Prior Authorization Criteria

Requests for Special Authorization are considered for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional, and/or biologic therapy.

Requests for special authorization will be considered for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional and/or biologic therapy.

Requests for Special Authorization are considered for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Requests for special authorization will be considered for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients.

Requests for special authorization are considered for:

Plaque Psoriasis:

In adult patients for the treatment of chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Psoriatic Arthritis:

For the treatment of adult patients with active psoriatic arthritis. Jamteki can be used alone or in combination with methotrexate (MTX).

Requests for special authorization are considered for:

Plaque Psoriasis:

- the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.

- the treatment of chronic moderate to severe plaque psoriasis in pediatric patients (6-17 years of age) who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Psoriatic Arthritis:

- the treatment of adult patients with active psoriatic arthritis. Wezlana can be used alone or in combination with methotrexate (MTX).

Crohn’s Disease:

- the treatment of adult patients with moderately to severely active Crohn’s disease, who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids.

Ulcerative Colitis:

- the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies

Allergic Asthma:

Requests for Special Authorization approval of Xolair® will depend on the following criteria including, but not limited to:

- Patient is diagnosed with allergic asthma as established by skin or blood tests and history
- Patient is diagnosed with moderate to severe persistent Asthma
- Patient is being prescribed Xolair® and followed by a specialist (such as):
- a Respirologist with certification from the Royal College of Physicians & Surgeons or Collège des Médicins du Quebéc or
- a Pediatrician with Respirologist designation or
- either an Internist or Pedicatrician with clinical Immunology and Allergy certification by either of the two bodies mentioned above
- Environmental issues considered and addressed as reasonably possible
- Patient has had inadequate response to or has developed intolerable side effects to first line maintenance therapies
- Baseline IgE level
- Evidence of reversible disease
- Patient's weight
- Patient is a non-smoker

Because these cases are not always easily definable using black and white criteria, each case will be reviewed by our Respirology physician to confirm that Xolair® would be an effective medication to include in the patient's overall treatment plan. For efficient claims processing, please ensure a special authorization form is completed and accompanied by supporting documentation including those mentioned above.

Chronic Idiopathic Uticaria (CIU):

Requests for special authorization are considered for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment.

Requests for Special Authorization are considered for:
- the treatment of neovascular (wet) age-related macular degeneration
- the treatment of visual impairment due to diabetic macular edema
- the treatment of visual impairment due to macular edema secondary to retinal vein occlusion
- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)

Requests for Special Authorization are considered for the treatment of moderate to severe plaque psoriasis (PsO) in adult patients who are candidates for systemic therapy or phototherapy.

Requests for Special Authorization are considered for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Requests for special authorization are considered for adult patients with inadequately controlled type 2 diabetes mellitus on triple therapy with a GLP-1 receptor agonist and two oral agents or dual therapy with a GLP-1 receptor agonist and basal insulin.

Note: DPP-4 inhibitors and GLP-1 receptor agonists should not be combined, as there do not appear to be additive effects on glucose lowering.

Requests for special authorization for Xywav will be considered only for patients meeting all of the criteria:

a) Enrolled in the Jazz Success Program (see below for details);

b) Diagnosis of cataplexy associated with narcolepsy

c) Currently receiving treatment with a CNS stimulant

d) No current use of alcohol, sedative hypnotics, or other CNS depressants

e) Age > 18 years of age.

Note: Xywav is available only through a single central pharmacy, and patients must enrol in the Jazz Success Program in order to receive the medication.

Requests for special authorization are considered for the prevention of episodic migraine (< 15 migraine days per month) in adults.

Requests for Special Authorization are considered for:

Ankylosing Spondylitis (AS, radiographic axial spondyloarthritis):

- the treatment of adults with active ankylosing spondylitis who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable.

Non-radiographic Axial Spondyloarthritis (nr-axSpA):

- the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable.

Requests for Special Authorization are considered for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable.

Requests for special authorization are considered as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults with the following conditions who are on maximally tolerated dose of a statin, with or without other LDL-C -lowering therapies:

• Heterozygous familial hypercholesterolemia (HeFH), or
• Non-familial hypercholesterolemia with atherosclerotic cardiovascular disease

Requests for special authorization will be considered for the treatment of inoperable adrenal cortical carcinoma of both functional and non-functional type.

Requests for special authorization are considered for the prevention of migraine in adults who have at least 4 migraine days per month.

Requests for special authorization are considered for the prevention of migraine in adults who have at least 4 migraine days per month.

Requests for Special Authorization are considered for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.

Requests for special authorization are considered for use as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of
- 30 kg/m2 or greater (obesity), or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.

Requests for Special Authorization are considered in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations.

Requests for special authorization are considered for the treatment of adult patients with rearranged during transfection (RET)fusion-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).

Requests for special authorization are considered for treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic agent.

Requests for special authorization will be considered in combination with pembrolizumab, for the treatment of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy and are not candidates for curative surgery or radiation.

Requests for special authorization will be considered for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Requests for special authorization will be considered for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

Requests for Special Authorization are considered as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma.

Requests for special authorization are considered in addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).

Requests for Special Authorization are considered for:

- the treatment of neovascular (wet) age-related macular degeneration

- the treatment of visual impairment due to diabetic macular edema

- the treatment of visual impairment due to macular edema secondary to retinal vein occlusion

- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)

Requests for Special Authorization are considered for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors.

Requests for Special Authorization are considered for the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies.

Requests for Special Authorization are considered for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable.

Requests for Special Authorization are considered for the treatment of:

- Neovascular (wet) age-related macular degeneration (AMD)

- Diabetic macular edema (DME)

Requests for special authorization are considered for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Requests for Special Authorization are considered for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease.

OPSYNVI® should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets

Requests for special authorization will be considered for patients who are intolerant to medroxyprogesterone unless it is unsuitable for the patient’s condition.

Requests for Special Authorization are considered for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib.

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients.

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Adult Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for Special Authorization are considered for the treatment of postmenopausal vulvovaginal atrophy.

Requests for Special Authorization are considered in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).

Requests for special authorization are considered as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

Requests for Special Authorization are considered for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with intact uterus.

Requests for Special Authorization are considered for the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy.

Requests for Special Authorization are considered for:

- the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
- the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
- the treatment of adult patients with chronic lymphocytic leukemia (CLL).

Requests for special authorization are considered for the treatment of adult and pediatric patients with solid tumours that:

- have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation,

- are metastatic or where surgical resection is likely to result in severe morbidity, and

- have no satisfactory treatment options.

Requests for Special Authorization are considered in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.

Requests for special authorization are considered for:

Cryopyrin-Associated Periodic Syndromes (CAPS)

For the ongoing management of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children aged 2 years and older, including:

- Familial Cold Autoinflammatory Syndrome (FCAS)/ Familial Cold Urticaria (FCU),

- Muckle-Wells Syndrome (MWS)

Neonatal-Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA).

Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)

For the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.

Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)

For the treatment of Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.

Familial Mediterranean Fever (FMF)

For the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients.

Still’s Disease

For the treatment of active Still’s disease including Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older, and adult-onset Still’s disease (AOSD).

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult

patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis

- in combination with MTX, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients, 2 years of age and older who have

had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients (PsA).

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Pediatric Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40 kg with severely active Crohn’s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor (TNF) alpha antagonist.

Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa (HS) in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg), who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients.

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Adult Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization are considered for:

Renal Cell Carcinoma (RCC)

- for the treatment of advanced RCC:

- In treatment-naïve adults with intermediate or poor risk.

- In adult patients who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.

Hepatocellular Carcinoma (HCC)

- for the treatment of patients with HCC who have been previously treated with sorafenib.

Requests for Special Authorization are considered for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs.

Requests for special authorization are considered for the prevention of migraine in adults who have at least 4 migraine days per month.

Requests for Special Authorization are considered for the treatment of patients with Wilson's Disease who are intolerant to penicillamine.

Requests for Special Authorization are considered for the treatment of patients with Wilson's Disease who are intolerant to penicillamine.

Requests for Special Authorization are considered for:

- the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

- the treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea (OSA)

Requests for Special Authorization are considered in combination with fulvestrant, for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CAmutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.

Requests for Special Authorization are considered for the treatment of splenomegaly and/or disease related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.

Requests for Special Authorization are considered for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Requests for Special Authorization are considered for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis (ATTR-CM), wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Requests for Special Authorization will be considered:

- Braftovi (encorafenib) in combination with Mektovi (binimetinib), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.

Requests for Special Authorization are considered for:

- the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(â)-thalassemia.

Requests for special authorization are considered for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.

Requests for special authorization are considered for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.

Requests for Special Authorization are considered:

- to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

- the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

Requests for special authorization will be considered for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

Requests for special authorization are considered to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to:

- established cardiovascular disease, or

- diabetes, and at least one other cardiovascular risk factor

Requests for special authorization are considered for the prevention of migraine in adults who have at least 4 migraine days per month.

Requests for special authorization are considered in combination with a SSRI or SNRI, for the treatment of major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.

Requests for special authorization are considered for:

- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:

(a) Diagnosis of moderate to severe rheumatoid arthritis AND:

The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:

(b) The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

- patients with ankylosing spondylitis who have failed a six-month trial of two different non-steroidal anti-inflammatory drugs (NSAIDS).

- treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

- treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years

- reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

- reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA).

Rheumatoid Arthritis:

- Requests for special authorization will be considered for use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:

- Diagnosis of moderate to severe rheumatoid arthritis AND:

The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:

- The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

Ankylosing Spondylitis:

-Requests for special authorization will be considered for the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis when the following criteria have been met:

- Diagnosis of ankylosing spondylitis AND :

- Medication is being prescribed by, or in consultation with, a rheumatologist or a specialist in the field of rheumatology AND:

- The patient has undergone a trial treatment of at least three months with 2 NSAIDs AND/OR the patient exhibits uveitis (iritis)

Psoriatic Arthritis:

- Requests for special authorization will be considered for the treatment of adult patients with active psoriatic arthritis (PSA) who meet ALL of the following criteria:

- The medication is prescribed by or in consultation with a rheumatologist, or a specialist in the field of RA or PsA

- The patient has had an inadequate response or intolerance to at least 2 disease modifying anti-rheumatic drugs (DMARDs), one of which must be methotrexate unless contraindicated . Patients must have had a trial of at least 3 months with these agents

Plaque Psoriasis:

- Requests for Special Authorization will be considered for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy who meet ALL of the following criteria:

- Patient has been diagnosed with chronic plaque psoriasis, and is being treated initially by a dermatologist, or in consultation with a dermatologist, (or a specialist, such as Internal Medicine),

- Patient has involvement in equal to or more than 10% body surface area. If the area is less than 10%, disabling psoriasis due to anatomic location (i.e., scalp, palmar, foot, or groin involvement) will allow the patient to qualify in he same manner as equal to or more than 10%.

- Patient has failed systemic therapy (for example with methotrexate. cyclosporine, or acitretin (Soriatane); must have had a trial of methotrexate (unless contraindicated).

- Patient has failed photochemical therapy,

- Patient is at least 18 years (adult in the submission) of age.

Crohn's Disease & Fistulizing Crohn’s Disease:

- Requests for special authorization will be considered for the reduction of signs and symptoms and induction and maintenance of clinical remission in adult patients with moderately to severely active Crohn’s disease when the following criteria have been met:

- Diagnosis of moderately to severely active Crohn’s disease AND:

- The patient must have had an inadequate response to conventional therapy

Ulcerative Colitis:

- Requests for special authorization will be considered for the reduction of signs and symptoms, inducing clinical remission, inducing mucosal healing, and reducing or eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Pediatric Crohn's Disease:

- reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (corticosteroid and/or aminosalicylate and/or immunosuppressant).

Pediatric Ulcerative Colitis:

- reduction of signs and symptoms, induction and maintenance of clinical remission, and induction of mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients.

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Pediatric Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40 kg with severely active Crohn’s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist.

Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, HULIO® should be used after phototherapy has been shown to be ineffective or inappropriate.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients.

Ankylosing Spondylitis

- reducing signs and symptoms in patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa in adult patients, who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, HYRIMOZ should be used after phototherapy has been shown to be ineffective or inappropriate.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients.

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Pediatric Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40 kg with severely active Crohn’s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist.

Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, Idacio® should be used after phototherapy has been shown to be ineffective or inappropriate.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis

- in combination with MTX, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients (PsA).

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Pediatric Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40 kg with severely active Crohn’s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor (TNF) alpha antagonist.

Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa (HS) in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg), who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis (Ps) who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, AMGEVITA should be used after phototherapy has been shown to be ineffective or inappropriate.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization are considered for:

Rheumatoid Arthritis

- reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older, who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis

- reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients.

Ankylosing Spondylitis

- reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Adult Crohn’s Disease

- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants.

Ulcerative Colitis

- treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

Hidradenitis Suppurativa

- treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg), who have not responded to conventional therapy (including systemic antibiotics).

Plaque Psoriasis

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, HADLIMATM (or HADLIMATM PushTouchTM) should be used after phototherapy has been shown to be ineffective or inappropriate.

Adult Uveitis

- treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Pediatric Uveitis

- treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization will be considered for:

- the treatment of Idiopathic Pulmonary Fibrosis (IPF).

- the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD).

Requests for special authorization are considered for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs.

Requests for special authorization are considered for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs.

Requests for special authorization will be considered:

- in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

- in combination with obinutuzumab, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

- in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Requests for special authorization are considered for:

- the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

- the treatment of adult patients with active psoriatic arthritis.

Requests for Special Authorization are considered for:

- the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

- as monotherapy for the maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Requests for special authorization are considered for:

- the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.

- the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.

Requests for special authorization will be considered for:

- the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

- alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD)

- the treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.

Requests for Special Authorization are considered for:

- in combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)

- as monotherapy for the treatment of patients with CLL who have received at least one prior therapy

- for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy

Requests for special authorization are considered for induction of clinico-pathological remission in adults with eosinophilic esophagitis (EoE).

Requests for special authorization are considered for the acute, intermittent treatment of “OFF” episodes in patients with Parkinson’s disease (PD).

Requests for special authorization are considered for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) not previously treated with crizotinib.

Requests for special authorization are considered for:

- the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

- the treatment of adult patients with active psoriatic arthritis.

Requests for special authorization for Cimzia™ are considered for:

- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:
(a) Diagnosis of moderate to severe rheumatoid arthritis AND:
The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:
(b) The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

- alone or in combination with MTX in adult patients with moderately to severely active PsA who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs).

- for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

- the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.

- the treatment of adults with severe active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and / or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Requests for Special Authorization are considered for add-on maintenance treatment of adult patients with severe eosinophilic asthma who:

- are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (eg, LABA) and

- have a blood eosinophil count of ≥400 cells/μL at initiation of the treatment or a level of 3% or more in induced sputum eosinophil count of total cells.

Requests for special authorization will be considered for:

- the treatment of acne vulgaris and/or papular and pustular acne which has failed other treatments (e.g. tretinoin, benzoyl peroxide or topical clindamycin)

- the treatment of acne vulgaris and/or papular acne if the patient is intolerant or allergic to other therapies (e.g. tretinoin, benzoyl peroxide or topical clindamycin)

Requests for special authorization will be considered for:
- the treatment of moderate to severe plaque psoriasis in patients 6 year and older who are candidates for systemic therapy or phototherapy
- the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.
- the treatment of adult patients with active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

- for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
- for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy

Requests for special authorization are considered for:

Women undergoing an assisted reproductive technology (ART) treatment to induce cycles that require luteal phase support (i.e. history of spontaneous abortion).

Requests for special authorization are considered for: patients who have undergone a solid organ or bone marrow transplant, for treatment of severe psoriasis; for patients who have failed conventional therapy with other agents (only requests from dermatologists are to be considered) for treatment of severe active rheumatoid arthritis; for patients in whom classic anti-rheumatics are ineffective or inappropriate (only requests from rheumatologists are to be considered) for treatment of steroid-dependent and steroid-resistant nephrotic syndrome due to glomerular disease (only requests from nephrologists or internists are to be considered).

Daklinza in combination with Sovaldi is not eligible for coverage for the treatment of genotype 3 chronic hepatitis C (CHC) patients. Alternative cost effective treatment options are eligible for coverage including Epclusa (pan genotypic, 12 weeks), with or without ribavirin.

Requests for special authorization will be considered for :

- the management of vasopressin sensitive central diabetes insipidus and the control of temporary polyuria and polydipsia following head trauma, hypophysectomy (removal of pituitary) or surgery in the pituitary region, in patients who for medical reasons are unable to use the nasal formulation.

- the short term management of nocturnal enuresis (bedwetting) in children five years of age and older, who have normal ability to concentrate urine.

Requests for special authorization are considered for:

- palliative treatment of inoperable progressing prostatic carcinoma in males

- hormone replacement therapy in females

- treatment advanced mammary carcinoma in post menopausal women.

Requests for Special Authorization are considered for:

Treatment of HIV-1 Infection
- in combination with other antiretrovirals (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg.

HIV-1 Pre-Exposure Prophylaxis (PrEP)
- for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ≥ 35 kg, excluding individuals at risk from receptive vaginal sex.

Requests for special authorization are considered for :

- documented iron deficiency for patients where oral forms of iron supplementation are contraindicated, not tolerated or have failed

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization are considered for :

- female patients with a diagnosis of severe acne, which is unresponsive to oral antibiotics (e.g. tetracycline) and other available treatments (e.g. isotretinoin), with associated symptoms of androgenization including seborrhea and mild hirsutism.

- hirsutism associated with PCOD (polycystic ovarian disease)

Requests for special authorization considered for:

- patients who require treatment of severe or life threatening systemic fungal infections including meningitis (oral suspension and tablets)

- patients who require treatment for severe dermatophytoses not responding to other forms of therapy including ketoconazole (oral suspension and tablets)

- patients who require prophylaxis treatment to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation and/or radiation therapy (oral suspension and tablets)

- treatment of oropharyngeal and esophageal candidiasis when other treatments have failed

Requests for Special Authorization are considered for:

- overactive bladder with symptoms of urinary frequency, urgency or urge incontinence where the patient has failed on, or proven intolerant to, a previous trial of first-line therapy (oxybutynin)

Requests for special authorization for Divigel are considered for:
The treatment of moderate to severe vasomotor symptoms associated with menopause.

Requests for special authorization will be considered for: protection against cholera in adults and children 2 years of age and older who will be visiting areas where there is risk of contracting cholera caused by V. cholerae. -protection against traveller's diarrhea in immunocompromised (e.g. HIV infection, transplant patients) adults and children 2 years of age and older who will be visiting areas where there is risk of contracting traveller's diarrhea caused by enterotoxigenic E. coli

Requests for special authorization will be considered for:

- reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults.

- for the symptomatic treatment of focal spasticity affecting the upper limbs in adults.

- for the symptomatic treatment of lower limb spasticity in pediatric patients 2 years of age and older

Requests for special authorization will be considered for clients diagnosed with moderate to severe Alzheimer's disease. For approval purposes, moderate to severe corresponds to a Mini Mental State Exam (MMSE) score of 5 to 15 inclusively.

Requests for special authorization are considered for:

- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:

(a) Diagnosis of moderate to severe rheumatoid arthritis AND:

The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:

(b) The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

- patients with psoriatic arthritis that does not respond to conventional treatments

- patients with ankylosing spondylitis who have failed a six-month trial of two different non-steroidal anti-inflammatory drugs (NSAIDS).

- patients aged 4 to 17 with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Requests for Special Authorization will be considered for the treatment of pediatric patients ages 4 to 17 years OR adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy.

Criteria:

1. Patient has been diagnosed with chronic plaque psoriasis, and is being treated initially by a dermatologist, or in consultation with a dermatologist, (or a specialist, such as Internal Medicine),

AND

2.Patient has involvement in equal to or more than 10% body surface area. If the area is less than 10%, disabling psoriasis due to anatomic location (i.e., scalp, palmar, foot, or groin involvement) will allow the patient to qualify in he same manner as equal to or more than 10%

AND

3. Patient has failed systemic therapy (for example with methotrexate or acitretin (Soriatane); must have had a trial of methotrexate (unless contraindicated),,

AND

4.Patient has failed photochemical therapy

Requests for special authorization will be considered for:
- the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNF_ antagonist.
- the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a tumor necrosis factor-alpha (TNF_) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.

Requests for Special Authorization are considered for the treatment of lab-confirmed pan-genotypic chronic hepatitis C virus (HCV) infection [genotypes 1-6], as monotherapy in adults without cirrhosis or with compensated cirrhosis and in combination with ribavirin in adults with decompensated cirrhosis, for a maximum of 12 weeks. Fibrosis stage must be provided.

NOTE: PATIENT APPROVALS WILL BE LIMITED TO ONE HEPATITIS C TREATMENT PER LIFETIME

Requests for special authorization are considered for:

- patients who have a documented allergy resulting in anaphylactic reactions.

Requests for special authorization are considered for patients suffering from anemia of the following types:

- Anemia of Chronic Renal Failure including patients on dialysis or not on dialysis: Non-dialysis patients with symptomatic anemia should have a hematocrit of less than 30% to be considered for therapy 2

- Anemia secondary to zidovudine treatment of AIDS/HIV: Patients treated with zidovudine (AZT) must have endogenous serum erythropoietin levels of less than or equal to 500 mU/mL and where the dose of zidovudine (AZT) is less than or equal to 4,200 mg/week.

- Anemia in cancer patients: Anemia in patients with non-myeloid malignancies may be disease related or may be secondary to chemotherapy. Treatment in patients with grossly elevated serum erythropoietin levels (>200 mU/mL) is not recommended.

Requests for Eprex treatment prior to an elective-surgical procedure will not be approved.

Requests for Special Authorization are considered for:

- treatment of moderately to severely active rheumatoid arthritis (RA) in adults.

- treatment of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

- treatment of active ankylosing spondylitis (AS).

- for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA).

- treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

- treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years.

Requests for special authorization are considered for:

- patients suffering from unacceptable adverse effects due to oral estrogen therapy (e.g. estrogen-induced hypertension or migraine)

- patients with a contraindication to oral therapy (e.g. dysphagia or liver disease)

- patients who have not had symptom relief with oral hormone replacement therapy

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization are considered in combination with other antituberculosis medications in the treatment of all forms of tuberculosis, including tuberculous meningitis, caused by Mycobacterium tuberculosis.

Requests for special authorization is considered for:

-patients diagnosed with Alzheimer's disease of mild to moderate severity. For approval purposes, mild to moderate severity corresponds to a Mini Mental State Exam (MMSE) score of 10 to 26 inclusively.

In advanced Alzheimer's, there is no evidence that the use of this product is beneficial and, therefore, the product is not a benefit. Cases of early-onset dementia (< than 60 years of age) require assessment by a neurologist or geriatrician before this product can be approved.

Requests for special authorization are considered for:
-patients diagnosed with Alzheimer's disease of mild to moderate severity. For approval purposes, mild to moderate severity corresponds to a Mini Mental State Exam (MMSE) score of 10 to 26 inclusively.

Requests for Special Authorization will be considered for patients with the following conditions:
the management of chronic iron overload in patients with transfusion-dependent anemias aged six years and older;
the management of chronic iron overload in patients with transfusion-dependent anemias aged two to five who cannot be adequately treated with deferoxamine. Therapy with Exjade® should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions.

Requests for special authorization are considered for:

- Patients with a diagnosis of relapsing-remitting multiple sclerosis or RRMS that has progressed to SPMS. The patient must have suffered a minimum of two exacerbations in the previous two years and must be able to walk with or without a walking aid.

- Patients presenting with a first isolated and well-defined neurologic event as consistent with MS and involving the optic nerve, spinal cord, brain stem or cerebellum. Patients must also have two or more clinically significant lesions of the brain that are at least 3mm in diameter on MRI scans and are characteristic of MS. Patients must also be able to walk with or without a walking aid

- For all requests the diagnosis must be made by a neurologist.

Requests for Special Authorization for Eylea are considered when prescribed by a qualified ophthalmologist experienced in intravitreal injections, or a retinal specialist. for:
- the treatment of (wet) age-related macular degeneration
- the treatment of diabetic macular edema (DME)
- the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)
- the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO)
- the treatment of myopic choroidal neovascularization (myopic CNV).

Any requests for Fabrazyme should be redirected to the The Canadian Fabry Disease Initiative (CFDI). All patients in Canada who are known to have Fabry disease or who may have Fabry disease based on a positive family history are encouraged to see a family physician for a referral to the appropriate Canadian Fabry Disease Initiative centre.

Requests for Special Authorization are considered for:

- for the treatment of estrogen receptor-positive, human epidermal growth receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

- for the hormonal treatment of locally advanced or metastatic breast cancer in postmenopausal women, regardless of age, who have disease progression following prior anti-estrogen therapy.

Requests for special authorization are considered for:

- the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate

- the treatment of patients with transfusional iron overload due to sickle cell disease or other anemias.

Requests for special authorization will be considered for:

- treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age, who are eligible for surgery.

- Intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age.

The duration of each treatment course is 3 months.

Requests for special authorization will be considered for the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase inhibitor deficiency.

Requests for special authorization are considered for:
patients with a diagnosis of advanced hormone-dependant prostate cancer in whom androgen deprivation is warranted.

Requests for special authorization will be considered for the long-term intravenous treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) or PAH associated with connective tissue diseases (CTD) in patients with WHO Functional Class III-IV symptoms who did not respond adequately to conventional therapy.

Requests for special authorization are considered for the treatment of benign prostate hyperplasia (BPH) in patients who have not responded to, who have not tolerated or who can not use alpha blockers on formulary (e.g. terazosin, doxazosin)

Requests for Special Authorization for Forteo will be considered under the following circumstances:
Individuals who are intolerant to oral bisphosphonates and Aclasta and Prolia
Individuals with a confirmed trial of antiresorptive therapy (patient compliant and persistent for at least one full year) and has significant BMD loss or unexpected fragility fractures after one full year of treatment
Individuals on current oral corticosteroids and are at very high risk of fracture as defined by:
Already has one or more vertebral fracture
Has very low BMD (T-score -3.5)
Has sustained a fracture while on treatment with an antiresorptive treatment

Forteo® (teriparatide) will be considered experimental and/or investigational for the treatment of any of the following:
A. Children and adolescents; or
B. Individuals with Paget's disease of the bone; or
C. Individuals with hypercalcemia; or
D. Women who are pregnant or nursing; or
E. Individuals who have diagnosed with bone cancer or other cancers that have metastasized to the bones.

Requests for special authorization for Fosamax will be considered for:

- the treatment of osteoporosis in postmenopausal women and men
who are deemed at high risk of fracture based on any one of the following:
-Prior fragility fracture after age 40, including asymptomatic vertebral fractures identified on X-rays
-Current use of oral corticosteroids (any dose)
-BMD report indicating high ten year fracture risk (defined as > 20%)
who are deemed at moderate risk of fracture based on BMD report, with at least one of the following compelling reasons to warrant treatment:
-Lumbar spine T-score much lower than femoral neck T-score (at least a difference of one full standard deviation)
-Rapid bone density loss ( 4% in the past year)
-Men receiving androgen-deprivation therapy for prostate cancer
-Women receiving aromatase-inhibitor therapy for breast cancer
-Repeated corticosteroid use (oral or parenteral) in last two years, even if patient is not currently on corticosteroid.
-Recurrent falls (2 or more in the past year)

-the treatment of Paget's disease of the bone in individuals who are symptomatic or with alkaline phosphatase level of at least two times the upper limit of normal

Requests for special authorization are considered for:

- patients who have a definite diagnosis of migraine AND have failed to respond to first-line abortive therapy (i.e. NSAIDs and standard analgesic therapy), unless contraindicated.

Requests for special authorization are considered for clients who meet the following criteria: HIV positive patients who have failed traditional antiretroviral therapy, defined as those patients who have failed at least 2 susceptible antiretrovirals and whose viral load is more than 5000

Galexos containing regimens are not eligible for coverage for the treatment of hepatitis C virus (CHC) infection genotypes 1 - 4. Alternative cost effective treatment options are eligible for coverage including Epclusa (pan genotypic, 12 weeks), Harvoni (genotype 1, 8 weeks), Holkira Pak (genotype 1, 12 weeks), Zepatier (genotype 1 & 4, 12 weeks) and Technivie (genotype 4, 12 weeks), with or without ribavirin.

Requests for special authorization for Gilenya are considered for the treatment of:

Adult patients with relapsing remitting multiple sclerosis (RRMS) who have failed therapy with an interferon-beta (i.e., Avonex, Betaseron, Rebif, Extavia) OR glatiramer acetate (Copaxone) OR Aubagio OR Tecfidera. The patient must have suffered a minimum of ONE exacerbations in the previous year and have an EDSS score less than or equal to 5.5.

- for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) who meet all of the following criteria:

- failure to respond to full and adequate courses of at least one interferon or glatiramer acetate OR Aubagio OR Tecfidera

- one or more clinically disabling relapses in the previous year.

- significant increase in T2 lesion load compared with that from a previous MRI scan (i.e. 3 or more new lesions) or at least one gadolinium-enhancing lesion.

- requested and followed by a neurologist experienced in the management of RRMS

Pediatric patients of 10 years to below 18 years of age with relapsing multiple sclerosis to reduce the frequency of clinical exacerbations.

Les demandes d’autorisation spéciale pour Giotrif sont admissibles dans le cas suivant :

- comme monothérapie chez les patients présentant un adénocarcinome du poumon métastatique (y compris un épanchement pleural diagnostiqué à la cytologie) porteurs de mutation(s) activatrice(s) du récepteur du facteur de croissance épidermique (R-EGF) et n’ayant jamais reçu d’inhibiteur de la tyrosine-kinase du R-EGF.

Requests for special authorization are considered for:
- the treatment of patients with unresectable and/or metastatic gastrointestinal stromal tumor (GIST),
- for the treatment of adult patients with chronic myeloid leukemia (CML)
- for the adjuvant treatment of adult patients who are at intermediate to high risk of relapse following-complete resection of Kit (CD117) positive GIST.

Requests for Special Authorization are considered for use in combination with metformin as an adjunct to diet and exercise, to achieve glycemic control in adult patients with type 2 diabetes mellitus (T2DM):
- inadequately controlled on metformin and empagliflozin, or
- inadequately controlled on metformin and linagliptin.

Requests for Special Authorization are considered for the treatment of lab-confirmed chronic hepatitis C virus (HCV) infection genotype 1, in treatment-naïve adults without cirrhosis and with pre-treatment HCV RNA load < 6 million IU/ml, for a maximum of 8 weeks. Fibrosis stage must be provided.

NOTE: PATIENT APPROVALS WILL BE LIMITED TO ONE HEPATITIS C TREATMENT PER LIFETIME.

Requests for special authorization are considered for the treatment of proliferating infantile hemangioma requiring systemic therapy:

• Life- or function-threatening hemangioma,

• Ulcerated hemangioma with pain and/or lack of response to simple wound care measures,

• Hemangioma with a risk of permanent scarring or disfigurement.

Requests for special authorization are considered for clients in whom a diagnosis of chronic hepatitis B has been made.
Hepsera is to be prescribed by or in consultation with a hepatologist, gastroenterologist or infectious disease specialist. These requests may include the following: A. Patients who cannot tolerate lamivudine or for whom lamivudine is contraindicated. B. Patients with lamivudine-resistant chronic hepatitis B who have failed on, or relapsed after lamivudine treatment; have developed viral resistance to lamivudine. C. Patients with severe liver disease who have decompensated chronic hepatitis B; have evidence of severe fibrosis or cirrhosis; are pre- or post-liver transplantation. The recurrence of chronic hepatitis B after liver transplantation results in increased risk for graft failure and death of patients. have compensated chronic hepatitis B and are at risk of liver decompensation (e.g., Chronic Hepatitis B flare, highly replicative HBV). D. Patients with HBV/HIV co-infection who are not on antiviral agents but require HBV treatment only (treatment for these patients should be undertaken in conjunction with infectious disease specialist physician).

Requests for Special Authorization are considered for the treatment of lab-confirmed chronic hepatitis C virus (HCV) infection, with fibrosis stage F2 or greater, in adult patients with genotype 1a or 1b without cirrhosis or genotype 1b with cirrhosis, for a maximum of 12 weeks.

NOTE: PATIENT APPROVALS WILL BE LIMITED TO ONE HEPATITIS C TREATMENT PER LIFETIME.

Requests for special authorization are considered for:

- Pediatric Growth Hormone Deficiency - Patients who have growth failure due to growth hormone inadequacy.

- Turner Syndrome - Patients who have short stature associated with Turner Syndrome

- Adults Growth Hormone Deficiency - Replacement of endogenous growth hormone in adults with growth hormone deficiency who meets either of the following two criteria:

(A) Adult Onset (AO) - Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; OR

(B) Childhood Onset (CO) - Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Requests for Special Authorization are considered for:

Rheumatoid Arthritis:

- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:

(a) Diagnosis of moderate to severe rheumatoid arthritis AND:

The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:

(b) The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

Psoriatic Arthritis:

- Patients with moderate to severe psoriatic arthritis who have had an inadequate response to at least two disease modifying antirheumatic drugs (DMARDS), one of which must be methotrexate unless contraindicated.

Ankylosing Spondylitis:

- Patients with moderate to severe ankylosing spondylitis who have failed to respond to sequential use of at least 2 NSAIDs at optimum dose. If there is a history of recurrent uveitis as a manifestation of ankylosing spondylitis, reimbursement can be authorized as first line therapy.

Crohn’s Disease:

- Patients with moderately to severely active Crohn’s disease who have had an inadequate response , or intolerance to:

A 6 week trial of sulfasalazine if there is mild active Crohn’s disease involving the colon OR oral or intravenous corticosteroids for more severe Crohn’s disease

AND A trial of immunosuppresants (i.e., azathioprine, 6-mercaptopurine or methotrexate) for a minimum of 3 months unless the severity of the disease requires earlier use of TNF inhibitors.

Fistuliizing Crohn’s Disease:

- Patients with fistuliizing Crohn’s disease who have had an inadequate response or intolerance to An appropriate course of antibiotic therapy AND A 3 month trial of immunosuppressants (i.e., azathioprine, 6-mercaptopurine, methotrexate)

Polyarticular Juvenile Idiopathic Arthritis

- in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). HUMIRA® can be used as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate.

Ulcerative Colitis:

-reducing signs and symptoms, inducing and maintaining clinical remission, inducing and maintaining mucosal healing, and reducing or eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Pediatric Crohn’s Disease

- Patients (between 13 and 17 years of age) diagnosed with pediatric Crohn’s Disease weighing ≥ 40 kg with severely active Crohn’s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist.

Plaque Psoriasis:

- adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy.

1. Patient has been diagnosed with chronic plaque psoriasis, and is being treated initially by a dermatologist, or in consultation with a dermatologist, (or a specialist, such as Internal Medicine),

AND

2. Patient has involvement in equal to or more than 10% body surface area. If the area is less than 10%, disabling psoriasis due to anatomic location (i.e., scalp, palmar, foot, or groin involvement) will allow the patient to qualify in the same manner as equal to or more than 10>#/p###

AND

3. Patient has failed systemic therapy (for example with methotrexate. cyclosporine, or acitretin (Soriatane); must have had a trial of methotrexate (unless contraindicated),,

AND

4. Patient has failed photochemical therapy,

AND

5. Patient is at least 18 years (adult in the submission) of age.Requests for Special Authorization will be considered for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy.

Hidradenitis Suppurativa:

- For the treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).

Uveitis:

- For the treatment of non-infectious uveitis (intermediate, posterior and panuveitis) in adult patients with inadequate response to corticosteroids or as corticosteroid sparing treatment in corticosteroid-dependent patients.

Humira should not be used in combination with other TNF antagonists. The medication must have been prescribed by, or in consultation with, a specialist (i.e., rheumatologist, gastroenterologist, internal medicine specialist).

Pediatric Uveitis:

- For the treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Requests for special authorization will be considered for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced ormetastatic breast cancer in combination with:

- an aromatase inhibitor as initial endocrine-based therapy; or

- fulvestrant in patients with disease progression after prior endocrine therapy. Pre- or perimenopausal women must also be treated with a luteinizing hormone releasing hormone (LHRH) agonist.

Requests for special authorization will be considered for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including CML or Ph+ ALL that is T315I mutation positive or where there is prior TKI resistance or intolerance.

Requests for special authorization are considered for:

- the treatment of patients with previously untreated active Chronic Lymphocytic Leukemia (CLL), including those with 17p deletion.

- in combination with obinutuzumab for the treatment of patients with previously untreated active CLL, including those with 17p deletion.

- the treatment of patients with CLL who have received at least one prior therapy, including those with 17p deletion.

- in combination with venetoclax for the treatment of adult patients with previously untreated CLL, including those with 17p deletion.

- the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL)

- the treatment of patients with Waldenstrm's macroglobulinemia (WM).

Rheumatoid Arthritis:

- Requests for special authorization will be considered for use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:

- Diagnosis of moderate to severe rheumatoid arthritis AND:

The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:

- The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

Ankylosing Spondylitis:

-Requests for special authorization will be considered for the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis when the following criteria have been met:

- Diagnosis of ankylosing spondylitis AND :

- Medication is being prescribed by, or in consultation with, a rheumatologist or a specialist in the field of rheumatology AND:

- The patient has undergone a trial treatment of at least three months with 2 NSAIDs AND/OR the patient exhibits uveitis (iritis)

Psoriatic Arthritis:

- Requests for special authorization will be considered for the treatment of adult patients with active psoriatic arthritis (PSA) who meet ALL of the following criteria:

- The medication is prescribed by or in consultation with a rheumatologist, or a specialist in the field of RA or PsA

- The patient has had an inadequate response or intolerance to at least 2 disease modifying anti-rheumatic drugs (DMARDs), one of which must be methotrexate unless contraindicated . Patients must have had a trial of at least 3 months with these agents

Plaque Psoriasis:

- Requests for Special Authorization will be considered for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy who meet ALL of the following criteria:

- Patient has been diagnosed with chronic plaque psoriasis, and is being treated initially by a dermatologist, or in consultation with a dermatologist, (or a specialist, such as Internal Medicine),

- Patient has involvement in equal to or more than 10% body surface area. If the area is less than 10%, disabling psoriasis due to anatomic location (i.e., scalp, palmar, foot, or groin involvement) will allow the patient to qualify in he same manner as equal to or more than 10%.

- Patient has failed systemic therapy (for example with methotrexate. cyclosporine, or acitretin (Soriatane); must have had a trial of methotrexate (unless contraindicated).

- Patient has failed photochemical therapy,

- Patient is at least 18 years (adult in the submission) of age.

Crohn's Disease & Fistulizing Crohn’s Disease:

- Requests for special authorization will be considered for the reduction of signs and symptoms and induction and maintenance of clinical remission in adult patients with moderately to severely active Crohn’s disease when the following criteria have been met:

- Diagnosis of moderately to severely active Crohn’s disease AND:

- The patient must have had an inadequate response to conventional therapy

Ulcerative Colitis:

- Requests for special authorization will be considered for the reduction of signs and symptoms, inducing clinical remission, inducing mucosal healing, and reducing or eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Requests for Individual Consideration for Inlyta will be considered for:

Patients with metastatic renal cell carcinoma (RCC) of clear cell morphology, after failure of initial treatment with sunitinib (Sutent®), sorafenib (Nexavar®) or pazopanib (Votrient). In addition, Inlyta should be reimbursed only if it is used as an alternative to everolimus (Afinitor) in cases when the patient is intolerant to or has a contraindication to the latter.

Requests for special authorization are considered for clients who meet the following criteria:

to be used in combination with other antiretroviral agents in treatment experienced adult patients who are infected with HIV-1 and who have documented resistance to at least one agent from each of the three major classes of antiretroviral agents [nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI)]

Requests for special authorization are considered for:

- Chronic Non-A, Non-B/C Hepatitis

- Chronic Active Hepatitis B: Candidates must be: HBeAg or HBV DNA positive, HIV negative, and have hepatitis but not decompensated liver disease.

- Chronic Myelogenous Leukemia: Reserved for patients who are not candidates for bone marrow transplant or have relapsed after one marrow transplant.

-Multiple Myeloma

- Non-Hodgkin's Lymphoma

- Malignant Melanoma

- AIDS Related Kaposi's Sarcoma

- Hairy Cell Leukemia: In patients where cladribine and/or pentostatin has failed or is not indicated.

- Basal Cell Carcinoma: Detailed information as to why surgery and/or radiation are deemed not appropriate must be provided

- Condylomata Acuminata

Requests for Special Authorization will be considered for patients with the following conditions:
the management of chronic iron overload in patients with transfusion-dependent anemias aged six years and older;
the management of chronic iron overload in patients with transfusion-dependent anemias aged two to five who cannot be adequately treated with deferoxamine.

Therapy with Jadenu should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions.

Requests for Special Authorization are considered for:

Requests for reimbursement for Kineret will be considered for

the treatment of adult patients with moderate to severe rheumatoid arthritis who have had an inadequate response to treatment with two DMARDs (one of which must me methotrexate unless contraindicated) AND to two TNF-alpha inhibitors. Medication must have been prescribed by, or in consultation with, a rheumatologist.

Requests are considered for patients who have a diagnosis of Phenylketonuria (PKU), with baseline blood phenylalanine (Phe) levels > 360 μmol/L despite compliance with all recommendations for dietary intervention and monitoring, who have demonstrated a response to the initial 3 month trial of sapropterin [reimbursed through the manufacturer] and who meet the following criteria:

A >30% reduction in blood phenylalanine concentration compared with baseline* AND clinically meaningful improvement in neurocognitive or neurobehavioral function as determined by a healthcare professional

OR

A >30% reduction in blood phenylalanine concentration compared with baseline* AND demonstrated increase in dietary protein tolerance based on targets set between the clinician and patient

* Copy of test report is required.

Requests for special authorization are considered for:

- patients who suffer from nausea and vomiting with chemotherapy treatment.

Requests for treatment of malaria will be considered on an individual basis.

Requests for the prevention of malaria will not be considered.

Since malaria is not prevalent in Canada, consequently, medications used solely for the prevention of malaria (Lariam and Paludrine- [now discontinued]) are not eligible benefits.

Requests for special authorization will be considered for:

- the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with highly active disease defined by clinical and imaging features, despite an adequate course of treatment with at least two other disease modifying treatments (DMTs), or where any other DMT is contraindicated or otherwise unsuitable.

Requests for Special Authorization are considered for:

- Prevention of stroke and systemic embolic events in patients with atrial fibrillation, in whom anticoagulation is appropriate, and in whom warfarin therapy has failed, is unsuitable, or is contraindicated;

- Treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and PE in patients for whom warfarin therapy has failed, is unsuitable, or contraindicated.

Requests for special authorization are considered for:

- the prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: orthopedic surgery of the hip or knee; high risk abdominal, gynecological, or urological surgeries; colorectal surgery

- the prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis

- treatment of deep venous thrombosis with or without pulmonary embolism

- treatment of unstable angina or non-Q wave myocardial infarction, concurrently with ASA

- treatment of acute-ST segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI)Requests for special authorization are considered for:

- patients who require thromboprophylaxis related to abdominal surgery or orthopedic surgery of the hip or knee

Requests for Special Authorization are considered for:
- the treatment of neovascular (wet) age-related macular degeneration
- the treatment of visual impairment due to diabetic macular edema
- the treatment of visual impairment due to macular edema secondary to retinal vein occlusion
- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)

Requests for special authorization for Lyrica will be considered for patients with:
neuropathic pain, including pain associated with diabetic peripheral neuropathy & post herpetic neuralgia
fibromyalgia
who have not responded are have not tolerated treatment with an antidepressant (i.e., a tricyclic antidepressant, SSRI, SNRI) AND gabapentin, or whom a trial of these agents is inappropriate.

Requests for special authorization will be considered for :

- the treatment of severe nausea and vomiting associated with cancer chemotherapy in patients who have failed, are intolerant to or have a medical reason they cannot take other antinauseants (i.e. Stemetil, Zofran).

- the treatment of AIDS-related anorexia associated with weight loss in patients who have failed, are intolerant to or have a medical reason they cannot take Megace (megestrol).

Requests for special authorization are considered for:

- patients who have a definitive diagnosis of malaria

- prevention of malaria will NOT be considered for coverage

Requests for special authorization are considered for weight reduction in conjunction with a reduced calorie diet and an exercise program and for long-term maintenance of weight loss in patients:

- with a BMI greater than 30kg/m2

- with greater than 27kg/m2 in the presence of comorbidities such as elevated blood pressure, heart disease, diabetes or arthritis.

Requests for special authorization are considered for:
- the treatment of osteoporosis in females greater than five years postmenopause with low bone mass. These patients must have bone density of at least 2.0 standard deviations below premenopausal mean or have a history or presence of osteoporotic fracture.

This includes patients:
a) who cannot tolerate treatment with estrogens; or
b) in whom estrogens are contraindicated.

Requests for special authorization will be considered for:

- the treatment of opioid-induced constipation (OIC) in adult patients with non-cancer pain who have had an inadequate response to laxative(s).

Requests for special authorization for Mozobil will be considered for:
- in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Some patients with NHL and MM are able meet minimal and target HSC collection criteria with G-CSF alone.

Requests for special authorization are considered for:

- prophylaxis of organ rejection in patients receiving allogenic renal, cardiac or hepatic transplants

Requests for special authorization for Myrbetriq will be considered for:
- treatment of overactive bladder (OAB) with symptoms of urgency, urgency incontinence and urinary frequency

Requests for special authorization are considered for:

- patients who have undergone a solid organ or bone marrow transplant

- for treatment of severe psoriasis for patients who have failed conventional therapy with other agents (only requests from dermatologists are to be considered)

- for treatment of severe active rheumatoid arthritis for patients in whom classic anti-rheumatics are ineffective or inappropriate (only requests from rheumatologists are to be considered)

- for treatment of steroid-dependent and steroid-resistant nephrotic syndrome due to glomerular disease (only requests from nephrologists or internists are to be considered).

Requests for special authorization are considered for clients who are receiving myelosupressive chemotherapy and require prevention of febrile neutropenic episodes. Requests should be made by, or in consultation with, a specialist in Oncology, Hematology, Infectious diseases, or Internal medicine

Requests for Special Authorization are considered:
- for the management of pain and inflammation associated with cataract surgery.

Requests are considered for special authorization for:
- the treatment of advanced or metastatic Renal Cell (clear cell) Carcinoma (RCC) in patients who failed prior cytokine therapy or who are considered unsuitable for such initial therapy.
- the treatment of unresectable (inoperable) hepatocellular carcinoma (HCC).
- the treatment of patients with locally advanced or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine.

Requests for special authorization are considered for patients
a) Who have failed at least 3 other PPIs: Pariet (rabeprazole), generic omeprazole, Prevacid (lansoprazole) OR Tecta (pantoprazole magnesium)
b) Have a medical reason why Pariet (rabeprazole), generic omeprazole, Prevacid (lansoprazole) OR Tecta (pantoprazole magnesium) cannot be used AND
c) Being treated for one of the following conditions:

1. Duodenal Ulcer
2. Gastric Ulcer
3. Reflux Esophagitis
4. Zollinger-Ellison Syndrome:
5. Eradication of Helicobacter Pylori:
Patients with newly diagnosed H pylori positive duodenal or gastric
ulcer, clients with H Pylori infection and proven relapsing duodenal or
gastric ulcers (including those on maintenance therapy for recurrent PUD),
and H Pylori-positive clients who are sufficiently symptomatic (from
gastritis, non-ulcer dyspepsia, etc...) to require maintenance therapy

6. Previous upper GI bleed
7. Prevention or treatment of NSAID-induced sequelae. This includes clients
who are currently taking NSAIDs or have recently stopped but require short
term treatment (up to eight weeks).

Requests for special authorization are considered for:

- Pediatric Growth Hormone Deficiency - Patients who have growth failure due to growth hormone inadequacy.

- the treatment of children with short stature associated with Turner syndrome.

Requests for special authorization will be considered:

- as add-on maintenance treatment for adults, adolescents, and children (aged 6 years and older) with severe eosinophilic asthma who:

- are inadequately controlled with high-dose inhaled corticosteroids (patients ≥ 18 years of age) or medium-to-high-dose inhaled corticosteroids (patients 6-17 years of age) and an additional asthma controller(s) (e.g., LABA); and

- have a blood eosinophil count of ≥ 150 cells/ìL (0.15 GI/L) at initiation of treatment with NUCALA OR ≥ 300 cells/ìL (0.3 GI/L) in the past 12 months.

- as add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.

- as an add-on to standard therapy for the treatment of adult patients with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

Requests for special authorization are considered for:

- patients suffering from unacceptable adverse effects due to oral estrogen therapy (e.g. estrogen-induced hypertension or migraine)

- patients with a contraindication to oral therapy (e.g. dysphagia or liver disease)

- patients who have not had symptom relief with oral hormone replacement therapy

Requests for special authorization are considered for patients requiring treatment of
inflammatory and pruritic manifestations of moderate to severe atopic dermatitis.

Requests for special authorization are considered for:

- Pediatric Growth Hormone Deficiency - Patients who have growth failure due to growth hormone inadequacy.

- Turner Syndrome - Patients who have short stature associated with Turner Syndrome

- Adults Growth Hormone Deficiency - Replacement of endogenous growth hormone in adults with growth hormone deficiency who meets either of the following two criteria:

(A) Adult Onset (AO) - Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; OR

(B) Childhood Onset (CO) - Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Requests for special authorization will be considered for the topical treatment of facial erythema of rosacea in adults 18 years of age or older.

Requests for Special Authorization for Opsumit are considered for the:
- the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group l) to reduce morbidity in patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease. Opsumit is effective when used as monotherapy or in combination with phosphodiesterase-5 inhbitors.

Requests for Special Authorization are considered for the treatment of symptoms of seasonal grass pollen allergic rhinitis with or without conjunctivitis.

Requests for reimbursement of Orencia will be considered for use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:
- Diagnosis of moderate to severe rheumatoid arthritis AND:
The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:
- The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

Requests for reimbursement of Orencia® will be considered for the treatment of pediatric patients (6 years of age and older) who have been diagnosed with Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) who have had an inadequate response to treatment with one or more DMARDs, AND Enbrel®. Medication must have been prescribed by, or in consultation with a rheumatologist.

Requests for special authorization will be considered for:
- the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
- alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD)

Requests will be considered for the treatment of an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence where the client has failed, or proven intolerant to, a previous trial of first line oral therapy such as oxybutin. Requests for the treatment of stress incontinence will not be considered.

Requests for special authorization are considered for patients
a) Who have failed 2 of the 3 following drugs:
Pariet (rabeprazole), generic omeprazole OR Tecta (pantoprazole magnesium)
b) Have a medical reason why Pariet (rabeprazole) or generic
omeprazole or Tecta (pantoprazole magnesium) cannot be used AND
c) Being treated for one of the following conditions:

1. Duodenal Ulcer
2. Gastric Ulcer
3. Reflux Esophagitis
4. Zollinger-Ellison Syndrome:
5. Eradication of Helicobacter Pylori:
Patients with newly diagnosed H pylori positive duodenal or gastric
ulcer, clients with H Pylori infection and proven relapsing duodenal or
gastric ulcers (including those on maintenance therapy for recurrent PUD),
and H Pylori-positive clients who are sufficiently symptomatic (from
gastritis, non-ulcer dyspepsia, etc...) to require maintenance therapy

6. Previous upper GI bleed
7. Prevention or treatment of NSAID-induced sequelae. This includes clients
who are currently taking NSAIDs or have recently stopped but require short
term treatment (up to eight weeks).

Requests for special authorization are considered for:

- patients in whom a diagnosis of chronic hepatitis C has been made. Pegetron is to be prescribed only by physicians who are familiar with the treatment of chronic hepatitis C.

Requests for special authorization will be considered for osteoarthritis of the knee and other related musculoskeletal conditions (e.g. tendonitis, bursitis, sprains, strains) in patient who have failed on at least two oral NSAIDS or are unable to tolerate at least two oral NSAIDS, or who have medical reasons why oral NSAIDS cannot be used (e.g. drug interactions with warfarin, previous GI bleed).

Requests for special authorization for Picato will be considered for:
- the topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) in adults

Requests for special authorization are considered for the treatment of relapsing remitting multiple sclerosis (RRMS) for adult patients:
- to reduce the frequency of clinical exacerbations
- to slow the progression of disability.

For all requests the diagnosis must be made by a neurologist.

Requests for Special Authorization are considered for:

prophylaxis of Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or hematopoietic stem cell transplant (HSCT) recipients.

treatment of invasive aspergillosis in patients 13 years of age or older with disease that is refractory to amphotericin B or itraconazole, or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

treatment of oropharyngeal candidiasis (OPC) in patients 13 years of age or older.

Requests for special authorization are considered for:
- patients suffering from Peyronie's disease, scleroderma, dermatomyositis, or morphea and linear scleroderma.

Requests for Special Authorization are considered for the:

- prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery;

- treatment of venous thromboembolism events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PEin patients for whom warfarin therapy has failed, is unsuitable, or contraindicated;

- prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is warranted, and in whom warfarin therapy has failed, is unsuitable, or is contraindicated.

Requests for special authorization are considered for:

-patients with emphysema due to alpha-1 antitrypsin deficiency when ALL of the following criteria are meet:

1. Patient is a non-smoker

2. Patient is over 18 years of age

3. Patient has a low serum concentration of alpha-1 antitrypsin (AAT) <50 mg/dl or < 11 uM/L 0r 0.8 g/L (35% of normal), which is considered the threshold thought to protect against emphysema; and

4. Patient has progressive emphysema with a documented rate of decline in FEV1.

Requests for special authorization are considered for:

Osteoporosis in post-menopausal women who meet Special Authorization criteria for reimbursement of alendronate and/or risedronate for the treatment of osteporosis

AND have at least one of the following:

• Intolerant to oral bisphosphonates
• Contraindication to oral bisphosphonates

The treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy

The treatment to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture.

The treatment to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy, who have low bone mass and are at high risk for fracture.

The treatment to increase bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy.

Requests for special authorization are considered for :

- patients with a diagnosis of moderate symptomatic benign prostatic hyperplasia who are not candidates for immediate surgery. These patients would otherwise be considered for elective surgery or qualify as poor surgical candidates.

Requests for special authorization are considered for :

- patients with a diagnosis of moderate to severe atopic dermatitis (eczema) that has not responded to first-line therapy (topical corticosteroids).

Requests for children under two years of age will be reviewed under individual assessment.

Requests for special authorization are considered for:
- the management of cystic fibrosis (CF) patients to reduce the frequency of respiratory infections requiring parenteral antibiotics and to improve pulmonary function. Safety and efficacy of daily administration have not been demonstrated in patients with FVC < 40% of predicted, or for longer than 12 months.

Requests for Special Authorization are considered for the management of cystic fibrosis (CF) in patients aged 18 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections.

Requests for Special Authorization are considered for:
- Patients who have a diagnosis of mild to moderate essential hypertension
AND
Have tried at least 2 other anti- hypertensive medications

Requests for special authorization are considered for:

- Patients with a diagnosis of relapsing-remitting multiple sclerosis or RRMS that has progressed to SPMS. The patient must have suffered a minimum of two exacerbations in the previous two years and must be able to walk with or without a walking aid.

- Patients presenting with a first isolated and well-defined neurologic event as consistent with MS and involving the optic nerve, spinal cord, brain stem or cerebellum. Patients must also have two or more clinically significant lesions of the brain that are at least 3mm in diameter on MRI scans and are characteristic of MS. Patients must also be able to walk with or without a walking aid

-For all requests the diagnosis must be made by a neurologist.

Rheumatoid Arthritis:
- Requests for special authorization of Remicade® will be considered for use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:
- Diagnosis of moderate to severe rheumatoid arthritis AND:
The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:
- The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

Crohn's Disease & Fistulizing Crohn's Disease:
- Requests for special authorization will be considered for Remicade® for the reduction of signs and symptoms and induction and maintenance of clinical remission in adult patients with moderately to severely active Crohn's disease when the following criteria have been met:
- Diagnosis of moderately to severely active Crohn's disease AND:
- The patient must have had an inadequate response to conventional therapy

Ankylosing Spondylitis:
-Requests for special authorization for Remicade® will be considered for the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis when the following criteria have been met:
- Diagnosis of ankylosing spondylitis AND :
Medication is being prescribed by, or in consultation with, a rheumatologist or a specialist in the field of rheumatology AND:
- The patient has undergone a trial treatment of at least three months with 2 NSAIDs AND/OR the patient exhibits uveitis (iritis)

Ulcerative Colitis:
-Requests for special authorization will be considered for Remicade® for the reduction of signs and symptoms, inducing clinical remission, inducing mucosal healing, and reducing or eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Psoriatic Arthritis
- Requests for special authorization will be considered for the treatment of adult patients with active psoriatic arthritis (PSA) who meet ALL of the following criteria:
- The medication is prescribed by or in consultation with a rheumatologist, or a specialist in the field of RA or PsA
- The patient has had an inadequate response or intolerance to at least 2 disease modifying anti-rheumatic drugs (DMARDs), one of which must be methotrexate unless contraindicated . Patients must have had a trial of at least 3 months with these agents

Plaque Psoriasis:
- Requests for Special Authorization will be considered for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy who meet ALL of the following criteria:
- Patient has been diagnosed with chronic plaque psoriasis, and is being treated initially by a dermatologist, or in consultation with a dermatologist, (or a specialist, such as Internal Medicine),
- Patient has involvement in equal to or more than 10% body surface area. If the area is less than 10%, disabling psoriasis due to anatomic location (i.e., scalp, palmar, foot, or groin involvement) will allow the patient to qualify in he same manner as equal to or more than 10%.
- Patient has failed systemic therapy (for example with methotrexate. cyclosporine, or acitretin (Soriatane); must have had a trial of methotrexate (unless contraindicated).
- Patient has failed photochemical therapy,
- Patient is at least 18 years (adult in the submission) of age.

Requests for Special Authorization for Repatha are considered for the reduction of LDL-C in:

Heterozygous Familial Hypercholesterolemia:

Patient has been diagnosed with Heterozygous Familial Hypercholesterolemia with documented baseline LDL-C > 4.9 mmol/; AND

Tendon xanthomas are present in the patient, or in any 1st degree relative (parent, sibling, child), or in 2nd degree relative (grandparent, uncle, aunt).

OR

Homozygous Familial Hypercholesterolemia:

Patient has been diagnosed with Homozygous Familial Hypercholesterolemia with documented baseline LDL-C >13mmol/L; AND

Tendon xanthomas are present in the patient; OR

Evidence of heterozygous familial hypercholesterolemia in both parents is provided.

OR

Atherosclerotic Cardiovascular Disease (ASCVD) - Secondary Prevention:

Patient is an adult with a confirmed diagnosis of clinical Atherosclerotic Cardiovascular Disease (ASCVD), as defined below.

Patient has ONEor more of the following in their medical history:

A. Coronary Heart Disease

Acute coronary syndrome

History of myocardial infarction (MI)

Stable or unstable angina

Coronary or other arterial revascularization

B. Cerebral Disease - Stroke or transient ischemic attack

C. Peripheral arterial disease (including abdominal aortic aneurysm)

Requirements for all requests:

Physician confirmation that patient has been provided nutritional counselling as part of treatment plan;

Recent reatedtest report of LDL-C >2.4 mmol/L (within 3 months of request date);

Documented statin medication history demonstrating patient adherence to maximally tolerated dose;

If statin dose is not maximized, physician confirmed and documented patient contraindication to statins (e.g. pregnancy, nursing, active liver disease) will be required; OR

Physician confirmed documented patient intolerance to statins (e.g. myositis, rhabdomyolysis) AND

Confirmation that other conditions have been ruled out as predisposing factors (drug interactions, untreated hypothyroidism, febrile illness, acute renal failure, biliary obstruction, alcoholism) AND

Confirmation that the patient has trialed and failed at least 2 different statins, one of which is at the lowest dose as a re-challenge.

Patient must be enrolled in the RepathaREADY™ Patient Support Program (the SP;

For all ASCVD requests, patients will be required to have documented trial of ezetimibe for at least 3 months.

Initial Renewal after maximum of 6 month trial:

Recent LDL-C test report demonstrating a minimum 50% reduction in the Patient's LDL-C after 12 week trial on Repatha (up to maximum of 24 weeks of use) and a demonstrated continued statin adherence.

Annual Renewals

Subsequent annual renewals will require that the Patient is continuing to derive clinical benefit from the drug and has demonstrated continued statin adherence. (Repatha's criteria)

Requests for special authorization will be considered for:

- treatment of the signs and symptoms of Parkinson's disease when the patient has failed, cannot tolerate or is unable to take levodopa, bromocriptine or pergolide, or as an adjunct to levodopa.

Requests for special authorization for Resotran are considered for:
The treatment of chronic constipation in women for whom treatment with at least two laxatives from different classes at the highest tolerated recommended doses for at least 6 months has failed to provide adequate relief for constipation

Requests for special authorization for Restasis are considered for patients with:
Moderate to moderately severe dry eyes (DEWS severity level of 2 3) who have not responded to treatment with preservative-free artificial tears.
Therapy with Restasis must be initiated by an ophthalmologist (or optometrist, in those provinces in which optometrists have been granted prescribing authority.)

Requests for Special Authorization are considered for:

- the treatment of patients with transfusiondependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

- in combination with dexamethasone for the treatment of multiple myeloma patients who are not eligible for stem cell transplant.

Requests for special authorization for Revolade will be considered for:

- the treatment of chronic immune thrombocytopenia purpura (ITP) to increase platelet counts in adult and pediatric patients one year and older who have had an insufficient response to corticosteroids or immunoglobulins.

- Adults (≥18 years of age) to increase platelet counts in thrombocytopenic patients with chronic hepatitis C virus (HCV) infection to allow the initiation and maintenance of interferon-based therapy.

- for the treatment of adult patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy.

Requests for Special Authorization are considered for:

- the treatment of schizophrenia in adults

- as an adjunct to antidepressants for the treatment of major depressive disorder (MDD) in adult patients with an inadequate response to prior antidepressant treatments during the current episode

Requests for Special Authorization for Rituxan are considered for
- the reduction of signs and symptoms in adult patients with moderately or severely active rheumatoid arthritis who have had an inadequate response, or tolerance to one or more tumour necrosis factor (TNF) inhibitor therapies
- Induction remission therapy for patients with severely active granulomatosis with polyangitis (GPA) or microscopic polyangiitis (MPA) in whom the use of cyclophosphamide has failed or is not appropriate

Requests for special authorization will be considered for epileptic patients as adjunctive therapy in the management of patients who are not satisfactorily controlled with conventional therapy (e.g. carbamazepine, phenytoin). Requests will also be considered for the treatment of infantile spasms (West syndrome). Requests may be considered for children under the age of 18 years if requested from a neuologist, pediatrician, or specialist in the area of treating patients with epilepsy

Requests for special authorization are considered for:

- Pediatric Growth Hormone Deficiency - Patients who have growth failure due to growth hormone inadequacy.

- Children with Chronic Renal Insufficiency up to time of renal transplantation

- Turner Syndrome - Patients who have short stature associated with Turner Syndrome

- Adults Growth Hormone Deficiency - Replacement of endogenous growth hormone in adults with growth hormone deficiency who meets either of the following two criteria:

(A) Adult Onset (AO) - Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; OR

(B) Childhood Onset (CO) - Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization will be considered for clients who have
- undergone a solid organ or bone marrow transplant
- OR for treatment of severe psoriasis for clients who have failed conventional therapy with other agents (only requests from dermatologists are to be considered)
- OR for treatment of severe active rheumatoid arthritis for clients in whom classic anti-rheumatics are ineffective or inappropriate (only requests from rhematologists are to be considered)
-OR for treatment of steroid-dependent and steroid-resistant nephrotic syndrome due to glomerular disease (only requests from nephrologists or internists are to be considered).

Requests for special authorization for Saphris are considered for:
The treatment of schizophrenia in those patients for whom therapy with risperidone, olanzapine, or quetiapine has failed or is not appropriate.
The treatment of manic episodes in patients with bipolar I disorder for whom therapy with risperidone, olanzapine, or quetiapine has failed or is not appropriate.

Requests for special authorization are considered for use as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization are considered for adults of 16 years and older with compensated liver disease with evidence of viral replication and active liver inflammation in whom a diagnosis of chronic hepatitis B has been made.

Sebivo® is to be prescribed by or in consultation with a hepatologist, infectious disease specialist, or gastroenterologist.

These requests may include the following:

A. Patients who cannot tolerate lamivudine or for whom lamivudine is contraindicated, OR

B. Patients with lamivudine-resistant chronic hepatitis B who
have failed on, or relapsed after lamivudine treatment;
have developed viral resistance to lamivudine, OR

C. Patients with severe liver disease who
have decompensated chronic hepatitis B;
have evidence of severe fibrosis or cirrhosis;
are pre- or post-liver transplantation. The recurrence of chronic hepatitis B after liver transplantation
results in increased risk for graft failure and death of patients.
have compensated chronic hepatitis B and are at risk of liver decompensation (e.g., Chronic Hepatitis B flare, highly replicative HBV), OR

D. Patients with HBV/HIV co-infection who are not on antiviral agents but require HBV treatment only-
(treatment should be undertaken in consultation with a hepatologist, infectious
disease specialist, or gastroenterologist)

Requests for coverage of Sensipar may be considered for patients with
secondary hyperparathyroidism [a complication of chronic kidney disease (CKD)] on dialysis with PTH that is elevated above 33 pmol/L on more than 2 occasions, or rising and one of the following:
a. A previous parathyroidectomy
b. Are not eligible for surgical parathyroidectomy due to high operative risk medical conditions
c. Have calcific uremic arteriolopathy (CUA)
d. Standard therapy (vitamin D sterols and phosphate binders) has failed.
e. Vitamin D Sterols are contraindicated due to hypercalcemia (total calcium > 2.5 mmol/L on at least 2 occasions) AND/OR hyperphosphatemia (serum phosphorus > 1.8 mmol/L on at least 2 occasions)

Requests for special authorization will be considered for:

The treatment of schizophrenia in patients who:
1. have tried and failed therapy with one or more of any form (including generic or brand, immediate or extended release) of either quetiapine, olanzapine or risperidone; or

2. have a medical reason why one or more of any form of quetiapine, olanzapine or risperidone cannot be used.

The treatment of bipolar disorder in patients who:
1. have tried and failed therapy with one or more of a conventional mood stabilizer (e.g., lithium, divalproex) and one or more of any form of quetiapine, olanzapine or risperidone; or

2. have a medical reason why one or more of any form of lithium, divalproex, quetiapine, risperidone or olanzapine cannot be used.

The treatment of major depressive disorder who:
1. have tried and failed antidepressant drug therapy due to lack of efficacy and/or lack of tolerability.

Requests for special authorization for Simponi™ are considered for:

- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:
(a) Diagnosis of moderate to severe rheumatoid arthritis AND:
The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:
(b) The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

- adult patients to reduce the signs and symptoms associated with active ankylosing spondylitis (AS) in patients who have failed a six-month trial of 2 different non-steroidal anti-inflammatory drugs (NSAIDS).

- adult patients, alone or in combination with methotrexate, to reduce the signs and symptoms of moderately to severely active psoriatic arthritis (PsA). Patients must have failed at least 2 disease modifying antirheumatic drugs (DMARDS), one of which must be methotrexate unless contraindicated.

- adult patients with moderately to severely active Ulcerative Colitis (UC) who have had an inadequate response to, or have medical contraindications for, conventional therapy including corticosteroids, aminosalicylates, azathioprine (AZA), or 6-mercaptopurine (6-MP), for:
- Inducing and maintaining clinical response (reduction in signs and symptoms);
- Inducing clinical remission
- Achieving sustained clinical remission in induction responders;
- Improving endoscopic appearance of the mucosa during induction.

Request for special authorization will be considered for:

- long-term treatment of patients with acromegaly due to pituitary tumours who have had an inadequate response to - or cannot be treated with surgery and/or radiotherapy.

- for the relief of symptoms associated with acromegaly. (reduces blood levels of growth hormone and IGF-I).

- for the treatment of enteropancreatic neuroendocrine tumors in patients with grade 1 (G1) or a subset of grade 2 (G2; equivalent to Ki67<10%) unresectable, locally advanced or metastatic disease to delay progression.

Request for special authorization will be considered for the treatment of acromegaly in patients who have had an inadequate response to surgery, and/or radiation therapy or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels and to improve clinical signs and symptoms.

Sovaldi containing regimens are not eligible for coverage for the treatment of hepatitis C virus (CHC) infection genotypes 1 - 4. Alternative cost effective treatment options are eligible for coverage including Epclusa (pan genotypic, 12 weeks), Harvoni (genotype 1, 8 weeks), Holkira Pak (genotype 1, 12 weeks), Zepatier (genotype 1 & 4, 12 weeks) and Technivie (genotype 4, 12 weeks), with or without ribavirin.

Requests for special authorization are considered for :

- treatment of severe or life threatening systemic fungal infections

- treatment of non-life threatening histoplasmosis and blastomycosis

- treatment of cutaneous fungal infections or onychomycosis when other treatments have failed (e.g. ketoconazole, terbinafine)

Requests for special authorization are considered for the treatment of adults with Ph+ chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate.

Requests for special authorization are considered for:

- patients who fail to obtain pain relief from NSAIDs, standard analgesic therapy (including narcotics) and ergotamine preparations (when diagnosis is migraine)

- If the diagnosis is migraine - failure to respond or contraindication to prophylactic agents, or a frequency of headaches that is not sufficient to justify trial of prophylactic therapy.

Requests for special authorization for Stelara are considered for:

Adults:

Plaque Psoriasis:

- for the treatment of adult patients with chronic, moderate to severe plaque psoriasis in those patients who have failed systemic therapy with methotrexate, cyclosporine, or acitretin AND photochemical therapy.

Psoriatic Arthritis:

- for the treatment of adult patients with active psoriatic arthritis (PSA) who meet ALL of the following criteria:

- The medication is prescribed by or in consultation with a rheumatologist, or a specialist in the field of RA or PsA

- The patient has had an inadequate response or intolerance to at least 2 disease modifying anti-rheumatic drugs (DMARDs), one of which must be methotrexate unless contraindicated . Patients must have had a trial of at least 3 months with these agents.

Crohn’s Disease:

- for the treatment of adult patients with moderately to severely active Crohn’s disease, who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids.

Ulcerative Colitis:

- for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Pediatrics:

Plaque Psoriasis:

- for the treatment of chronic moderate to severe plaque psoriasis in pediatric patients (children and adolescents) from 6 to 17 years of age, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Requests for special authorization are considered for patients who require bone marrow transplant for:

- use in combination with Neupogen (filgrastim) to provide a sustained increase in the number of PBPC (peripheral blood progenitor cell) capable of engraftment, to increase the likelihood of patients reaching a PBPC target, and to reduce the number of aphereses required to collect a target number of PBPC

Requests will also be considered for patients receiving myelosuppressive or myeloblative chemotherapy.

Requests should be made by, or in consultation with, a specialist in oncology, hematology, infectious diseases or internal medicine.

Requests for special authorization are considered for:
- patients experiencing acne vulgaris

Requests for special authorization are considered for treatment of acne vulgaris. Requests will not be considered for photodamaged skin or intrinsic aging and related symptoms, such as aging or hyperpigmentation.

Requests for special authorization are considered for treatment of acne vulgaris. Requests will not be considered for photodamaged skin or intrinsic aging and related symptoms, such as aging or hyperpigmentation.

Requests for special authorization are considered for treatment of acne vulgaris. Requests will not be considered for photodamaged skin or intrinsic aging and related symptoms, such as aging or hyperpigmentation.

Requests for special authorization are considered for:

- men with advanced (Stage D) symptomatic carcinoma of the prostate where surgical orchiectomy is not a therapeutic option

- treatment of endometriosis for a maximum duration of six to nine months

Requests for special authorization for Sutent are considered for patients with metastatic renal cell carcinoma of clear cell histology who have received no prior systemic therapies or who have received prior treatment with cytokines for metastatic disease.

Request for special authorization are considered for patients with a diagnosis of GIST who have tried and failed Gleevec as first-line therapy.

Requests for special authorization are considered :

- when the patient is undergoing testing for adrenocortical function.

Requests for Special Authorization for Tafinlar (dabrafenib), in combination with Mekinist (trametinib) are considered for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Requests for Special Authorization for Tafinlar (dabrafenib), in combination with Mekinist(trametinib) are considered for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection.

Requests for Special Authorization are considered for:

- monotherapy for the first-line treatment of patients with locally advanced (stage III b, not amenable to curative therapy) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with EGFR activating mutations

- monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations after 4 cycles of standard platinum-based first-line chemotherapy.

- monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive

Requests for special authorization are considered for patients with:
Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
Ph+ chronic or accelerated phase CML with resistance or intolerance to prior therapy

Requests for special authorization are considered as monotherapy for adult patients for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability.

Requests for Special Authorization are considered for the treatment of adults with lab-confirmed genotype 4 chronic hepatitis C virus infection without cirrhosis who are either treatment naïve or previously treated with peg-interferon and ribavirin for a maximum of 12 weeks.

NOTE: PATIENT APPROVALS WILL BE LIMITED TO ONE HEPATITIS C TREATMENT PER LIFETIME.

Temodal capsules are indicated for the treatment of adult patients with glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) (with radiation therapy) and documented evidence of recurrence or progression after standard therapy.

Requests for special authorization for Tivicay are considered for the treatment of human immunodeficiency virus (HIV-1) infection in adults and in INSTI-naïve children weighing at least 30 kg.

Requests for special authorization are considered for short term management (not to exceed 5 days for post surgical or 7 days for musculoskeletal pain) for moderate to moderately severe acute pain, acute musculoskeletal trauma and post partum uterine cramping.
Requests will also be considered for the intermittent use for conditions such as migraine headaches and dental pain

Request for Special Authorization will be considered for the treatment of patients with hormone dependent advanced (stage D2) carcinoma of the prostate gland.

Requests for special authorization are considered for adults with partial seizures, as adjunctive therapy or monotherapy, and for children six years of age and older with partial seizures as adjunctive therapy. All patients must have uncontrolled seizures while on other medication, have contraindications to other medications or be unable to tolerate other medications (e.g.carbamazepine, phenytoin, valproic acid, divalproex)

Requests for special authorization will be considered for the treatment of Human Immunodeficiency Virus (HIV-1) infection in adults.

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization will be considered for sclerosing of varicose veins in patients with complications (e.g. venous insufficiency leading to deep vein thrombosis, severe bleeding or infection, ulcers or sores on skin due to lack of oxygen, phlebitis).
Requests will not be considered for treatment of varicose to alleviate leg muscle fatigue, leg cramps or for cosmetic reasons.

Requests for special authorization are considered for the following:
- the management of HIV-1 infection in adults, in combination with other antiretroviral agents.
- in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Requests for special authorization will be considered in combination with capecitabine for the treatment of patients with metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressed on taxanes and anthracycline before starting this therapy. In addition, patients should have progressed on prior trastuzumab therapy in the metastatic setting.

Requests for Special Authorization will be considered for patients who:

-are no less than 18 years of age;
-have been clinically diagnosed with and currently have the relapsing-remitting form of multiple sclerosis (safety and efficacy with chronic progressive MS have not been established);
-requests for Tysabri for the treatment of secondary progressive, primary progressive and progressive relapsing MS will be declined.
-have failed or are intolerant to one of the interferon beta products (Avonex®, Betaseron or Rebif®), AND have failed or are intolerant to Copaxone® (glatiramer) ;
-will be using Tysabri as monotherapy only;
-are being prescribed Tysabri by an MS-specialist or a neurologist;
-present with an EDSS score of 5.5 or less (ie. patient must be ambulatory);
-show a significant increase in T2 lesion load as compared to previous MRI or at least one gadolinium-enhancing lesion
AND,
-have had at least 2 relapses in the previous 12 month period;

Requests for Special Authorization will also be considered for patients who:
-have NOT failed or are intolerant to BOTH an interferon beta product AND Copaxone
IF
-showing an increase in EDSS score of 2.0 or greater over the previous 12 month period.
-all other criteria remain the same for these patients.

Requests for Special Authorization are considered for patients:
-no less than 18 years of age
-Clinically diagnosed relapsing-remitting form of multiple sclerosis (safety and efficacy with chronic progressive MS have not been established)
-Failed or intolerant to Copaxone® (glatiramer), AND have failed or intolerant to one of the interferon beta products (Avonex®, Betaseron or Rebif®)
-Being used as monotherapy only.
-Prescriber must be a neurologist or an MS-specialist (or in consultation with one)

Requests for special authorization will be considered for the long-term treatment of idiopathic pulmonary arterial hypertension (iPAH), heritable pulmonary arterial hypertension (HPAH), PAH associated with connective tissue disorders and PAH associated with congenital heart disease, in adult patients with WHO functional class (FC) II–III to delay disease progression.

Requests for special authorization will be considered for the treatment of CMV retinitis in adult patients with AIDS, as well as for the prevention of CMV retinitis in solid organ transplant patients at risk. (This drug does not fall under the list of provincial drug assistance medications for the treatment of the viral load associated with HIV/AIDS).

Requests for reimbursement of oral Vfend will be considered for the treatment of invasive aspergillosis (approved indication in Canada) as well as for the treatment of Candidemia and the following Candida infections: disseminated infections in the skin and infections in abdomen, kidney, bladder wall and wounds.

Requests for special authorization for Victoza™ are considered for:
Adult patients with inadequately controlled type 2 diabetes mellitus, who have had a trial of both metformin and at least one sulfonylurea

Requests for special authorization for Victrelis/Victrelis Triple are considered for:
The treatment of chronic hepatitis C genotype 1 infection in adults with compensated liver disease

Adult patients requiring the chronic use of NSAIDs who are at risk of developing gastric ulcers and who:

1. have tried and failed therapy with one or more of any drug containing any form (including generic or brand, immediate or extended release) of PARIET (rabeprazole), LOSEC (omeprazole), PREVACID (lansoprazole), TECTA (pantoprazole magnesium) or PANTOLOC (pantoprazole sodium); with Naproxen Sodium

2. have a medical reason why one or more of any form of rabeprazole, omeprazole, lansoprazole, pantoprazole magnesium or pantoprazole sodium cannot be used with Naproxen Sodium.

Requests for special authorization are considered for:
- adults with diagnosed with HIV-1 infection in combination with other antiretroviral agents

Request for special authorization will be considered for treatment of HIV infection when, because of intolerance or resistance, it is impossible to offer the patient a viable three-drug regimen from other antivirals on formulary.
Requests are also considered for the treatment of chronic hepatitis B in patients 18 years of age and older and who have failed treatment with lamivudine. Prescribed only by or in consultation with a hepatologist, infectious disease specialist, or gastroenterologist.

Requests for special authorization for Visanne™ will be considered for:
Management of endometriosis associated pelvic pain in female patients for whom less hormonal options such as oral contraceptives or medroxyprogesterone are either ineffective or cannot be used

Reimbursement will be considered for the treatment of (wet) age-related macular degeneration (AMD) in patients with predominantly classic choroidal neovascularization (CNV), pathologic myopia and presumed ocular histoplasmosis.

Only requests from ophthalmologists will be considered.

Requests for special authorization are considered for:
- patients with a medical diagnosis (other than weight loss) that require treatment with vitamin B6 or vitamin B12.

Requests for special authorization are considered for:

- patients with a medical diagnosis (other than weight loss) that require treatment with vitamin B6 or vitamin B12.

Requests for special authorization are considered for:

- patients suffering from unacceptable adverse effects due to oral estrogen therapy (e.g. estrogen-induced hypertension or migraine)

- patients with a contraindication to oral therapy (e.g. dysphagia or liver disease)

- patients who have not had symptom relief with oral hormone replacement therapy

Requests for Special Authorization are considered for Volibris for clients who have a diagnosis of:
a) primary (idiopathic) pulmomary arterial hypertension, OR
b) pulmonary arterial hypertension associated with connective tissue disease (CTD),
in patients with WHO functional III symptoms who have not responded to conventional therapy

Requests for special authorization for Votrient™ are considered
for patients with metastatic renal cell carcinoma who have received no prior systemic therapies or who have received prior treatment with cytokines for metastatic disease

Requests for special authorization are considered for the symptomatic treatment of depressive illness.

Requests for smoking cessation will not be considered.

Requests for special authorization are considered for:
- as monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

Requests for special authorization are considered for the treatment of benign prostate hyperplasia (BPH) in patients who have not responded to, who have not tolerated or who can not use alpha blockers on formulary (e.g. terazosin, doxazosin)

Requests for special authorization will be considered in combination with methotrexate or as monotherapy, will be considered for adult patients with moderate to severe rheumatoid arthritis who have tried and failed 2 DMARDs (eg. methotrexate).

Requests for special authorization will be considered for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNF-inhibitor.

Requests for special authorization will be considered in combination with methotrexate (MTX) or another conventional synthetic disease-modifying antirheumatic drug (DMARD), is indicated for reducing the signs and symptoms of psoriatic arthritis (PsA) in adult patients with active PsA when the response to previous DMARD therapy has been inadequate.

Requests for special authorization will be considered for:

Breast Cancer:
Combination Therapy: XELODA in combination with docetaxel is indicated for the
treatment of patients with advanced or metastatic breast cancer after failure of prior
anthracycline containing chemotherapy.
Monotherapy: XELODA is also indicated for the treatment of advanced or metastatic
breast cancer after failure of standard therapy including a taxane, unless therapy with a
taxane is clinically contraindicated.

Colorectal Cancer:
the first-line treatment of patients with metastatic colorectal cancer.

Requests for special authorization are considered for weight reduction in conjunction with a reduced calorie diet and an exercise program and for long-term maintenance of weight loss in patients:

- with a BMI greater than 30kg/m2

- with greater than 27kg/m2 in the presence of comorbidities such as elevated blood pressure, heart disease, diabetes or arthritis.

Requests for special authorization are considered for:

- patients 18 years of age and older with blepharospasm where treatment is currently being provided by an ophthalmologist or internist experienced in the use of botulinum toxin for the above indications.

- patients 18 years of age and older with cervical dystonia (spasmodic torticollis) where treatment is currently being provided by an internist experienced in the use of botulinum toxin for this indication

- patients 18 years of age and older with post-stroke spasticity of the upper limb where treatment is currently being provided by an internist experienced in the use of botulinum toxin for this indication

Requests for special authorization are considered for:

- Reducing the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours.

- Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Requests for special authorization will be considered for:

Treatment of metastatic castration-resistant prostate cancer (CRPC) in patients who:

- are chemotherapy-naïve with asymptomatic or mildly symptomatic disease after failure of androgen deprivation therapy.

- have received docetaxel therapy.

Treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).

Treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

Requests for special authorization for Xyrem will be considered only for patients meeting all
of the criteria:
a) Enrolled in the Xyrem Success Program (see below for details);
b) Diagnosis of cataplexy associated with narcolepsy
c) Currently receiving treatment with a CNS stimulant
d) No current use of alcohol, sedative hypnotics, or other CNS depressants
e) Age > 18 years of age.

Note: Xyrem is available only through a single central pharmacy, and patients must enrol in the Xyrem Success Program in order to receive the medication.

Requests for special authorization will be considered for:

- the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age.

- for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Requests for Special Authorization for Zelboraf are considered for the treatment of BRAV V600 mutation-positive unresectable stage IIIc or IV metastatic melanoma.

Requests for Special Authorization are considered for:
- the treatment of schizophrenia in patients who have tried and failed with either risperidone (Risperdal), or quetiapine (Seroquel) or have a medical reason why either of these medications can't be used.

Requests for special authorization will be considered for patients not adequately controlled with a regular benefit inhaled corticosteroid/long-acting beta2-adrenergic agonist combination product.

Requests for Special Authorization are considered for the treatment of lab-confirmed chronic hepatitis C virus (HCV) infection, with fibrosis stage F2 or greater, in adult patients with genotype 1 or genotype 4 with or without cirrhosis, who have not had on-treatment virologic failures, for a maximum of 12 weeks.

NOTE: PATIENT APPROVALS WILL BE LIMITED TO ONE HEPATITIS C TREATMENT PER LIFETIME.

Requests for Special Authorization are considered for the treatment of hormone-dependent advanced carcinoma of the prostate , hormonal dependent breast cancer and for the hormonal management of endometriosis.

Requests for Special Authorization will be considered for the treatment of hormone-dependent advanced carcinoma of the prostate and for the hormonal management of endometriosis.

Requests for special authorization are considered for:

- patients who have a definite diagnosis of migraine AND have failed to respond to first-line abortive therapy (i.e. NSAIDs and standard analgesic therapy), unless contraindicated.

Requests for special authorization are considered for :

- patients for the short-term (up to eight days) topical relief of histamine mediated pruritis of moderate severity, especially accompanying conditions such as eczematous dermatitis.

Requests for special authorization will be considered:

- in combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).

Requests for special authorization will be considered as monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib.

Requests for special authorization will be considered for:

- in combination with prednisone for the treatment of metastatic prostate cancer (castration-resistant prostate cancer, mCRPC) in patients who:

- are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy

- have received prior chemotherapy containing docetaxel after failure of androgen deprivation therapy

- in combination with prednisone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed hormone-sensitive high-risk metastatic prostate cancer who may have received up to 3 months of prior ADT.

Requests for special authorization are considered for clients who have been diagnosed with:
Vancomycin Resistant Enterococcus (VRE) infections, or nosocomial pneumonia caused by methicillin-resistant Staphyloccus aureus,or complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus and other susceptible organisms.Requests will only be considered when prescribed or recommended by an infectious disease specialist.

Requests for Special Authorization are considered for:

Ovarian Cancer:
- for the maintenance treatment of adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Patients must have confirmation of BRCA mutation (identified by either germline or tumour testing) before LYNPARZA treatment is initiated.

- as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.

Adenocarcinoma of the Pancreas:
- as monotherapy for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated.

Prostate Cancer:
- as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castrationresistant Prostate Cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent. BRCA or ATM mutations must be confirmed before LYNPARZA treatment is initiated.

- In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before LYNPARZA treatment is initiated..

Breast Cancer
- for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before LYNPARZA treatment is initiated.

Requests for Special Authorization are considered to slow the loss of function in patients with amyotrophic lateral sclerosis (ALS), as measured by the ALS Functional Rating Scale - Revised (ALSFRSR).

Requests for Special Authorization are considered for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Requests for Special Authorization are considered for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations).

Requests for special authorization are considered for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs.

Requests for special authorization are considered for:

- to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

in combination with glucocorticoids is indicated for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

Requests for Special Authorization are considered as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:

- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;

- in combination with other medicinal products for the treatment of diabetes for patient populations and drug combinations tested).

Requests for Special Authorization are considered for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Requests for special authorization will be considered for:

- reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and reduction or elimination of corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (ie, aminosalicylate and/or corticosteroid and/or an immunosuppressant).

- reduction of signs and symptoms, induction and maintenance of clinical remission, and induction of mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (ie, aminosalicylate and/or corticosteroid and/or an immunosuppressant). The safety and efficacy of infliximab have not been established in patients less than 6 years of age.

- reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate. AVSOLA can be used alone or in combination with conventional therapy.

- treatment of fistulising Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment.

- the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies.

- reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (corticosteroid and/or aminosalicylate and/or an immunosuppressant). The safety and efficacy of infliximab is not established in patients less than 9 years of age.

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy. For patients with chronic moderate plaque psoriasis, AVSOLA should be used after phototherapy has been shown to be ineffective or inappropriate. When assessing the severity of psoriasis, the physician should consider the extent of involvement, location of lesions, response to previous treatments, and impact of disease on the patient’s quality of life.

- reduction of signs and symptoms, induction of major clinical response, and inhibition of the progression of structural damage of active arthritis, and improvement in physical function in patients with psoriatic arthritis.

- use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis.

Requests for Special Authorization are considered for:

Advanced or Metastatic Breast Cancer:

For the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer:

- in combination with an aromatase inhibitor in postmenopausal women as initial endocrinebased therapy.

- in combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone (GnRH) agonist.

Early Breast Cancer:

In combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features.

Requests for Special Authorization are considered for:

- the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

- as monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Requests for special authorization will be considered:

(1) Cancer Patients Receiving Myelosuppressive Chemotherapy;

(2) Patients with Acute Myeloid Leukemia;

(3) Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation;

(4) Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy;

(5) Patients with Severe Chronic Neutropenia (SCN); and

(6) Patients with HIV- Infection.

Requests for special authorization will be considered when prescribed by a qualified ophthalmologist experienced in intravitreal injections, or a retinal specialist for the treatment of:

- neovascular (wet) age-related macular degeneration (AMD)
- diabetic macular edema (DME)

Requests for special authorization will be considered for:

- the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).

- the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.

Requests for special authorization will be considered in combination with methotrexate in adult patients to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

Requests for special authorization are considered for the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.

Requests for Special Authorization are considered for the treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability.

Requests for special authorization will be considered in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in patients, at least 12 years of age and weighing at least 35 kg, who are virologically stable and

suppressed (HIV-1 RNA less than 50 copies/mL) as:

• an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA
• oral bridging therapy for missed CABENUVA injections

Requests for special authorization will be considered as a complete regimen for the treatment of HIV-1 infection in patients, at least 12 years of age and weighing at least 35 kg, to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL).

Requests for Special Authorization are considered as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous 12 months.

Requests for Special Authorization are considered for:

- the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy.

- to increase bone mass in men with primary or hypogonadal severe osteoporosis who have failed or are intolerant to previous osteoporosis therapy. The effects of teriparatide on risk for fracture in men have not been demonstrated.

- the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture.

Requests for special authorization are considered for:

• Pediatric Growth Hormone Deficiency - Patients who have growth failure due to growth hormone inadequacy.
• Turner Syndrome - Patients who have short stature associated with Turner Syndrome
• Adults Growth Hormone Deficiency - Replacement of endogenous growth hormone in adults with growth hormone deficiency who meets either of the following two criteria:

(A) Adult Onset (AO) - Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; OR

(B) Childhood Onset (CO) - Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Requests for Special Authorization are considered for:

- the treatment of patients with lab-confirmed pan- genotypic chronic hepatitis C virus (HCV) infection [genotypes 1-6], with fibrosis stage F0* or greater, as monotherapy in adults and in pediatric patients 3 years of age and older weighing ≥ 12 kg, without cirrhosis or with compensated cirrhosis.

*Documentation of fibrosis stage is required for consideration of coverage, and recent viral load report (with HCV RNA level).

- the treatment of patients with lab-confirmed HCV genotype 1 infection previously treated with either a regimen of NS5A inhibitor (other than Maviret) or with a NS3/4A protease inhibitor, but not both classes of inhibitors.

Requests for special authorization will be considered for:

• prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy
• prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone.

Requests for Special Authorization are considered for the the long-term intravenous treatment of idiopathic pulmonary arterial hypertension (iPAH), heritable pulmonary arterial hypertension (HPAH) and pulmonary arterial hypertension associated with connective tissue disease in NYHA functional Class III and Class IV patients who did not respond adequately to conventional therapy.

Requests for Special Authorization are considered for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA

Requests for Special Authorization for Praluent are considered for the reduction of LDL-C in:

Heterozygous Familial Hypercholesterolemia (HeFH): Patient is an adult with a confirmed diagnosis of Heterozygous Familial Hypercholesterolemia, as defined below.

A. Patient had documented baseline total cholesterol > 7.5 mmol/L at diagnosis or baseline LDL-C > 4.9 mmol/L at diagnosis; and

B. Tendon xanthomas are present in the patient, or in any 1st degree relative (parent, sibling, child), or in 2nd degree relative (grandparent, uncle, aunt); or

C. Family history of myocardial infarction before the age of 50 years in a 2nd degree relative or before the age of 60 years in a 1st degree relative; or

D. Family history of total cholesterol concentration above 7.5 mmol/L in a 1st or 2nd degree relative.

Atherosclerotic Cardiovascular Disease (CVD): Patient is an adult with a confirmed diagnosis of atherosclerotic cardiovascular disease, as defined below.

Patient has ONE or more of the following in their medical history:

A. Coronary Heart Disease

• Acute coronary syndrome
• History of myocardial infarction (MI)
• Stable or unstable angina
• Coronary or other arterial revascularization

B. Cerebral Disease - Stroke or transient ischemic attack

C. Peripheral arterial disease

*In additional to maximally tolerated statin, patient should have trialed ezetimibe for at least 3 months.

Requirements for all requests:

• Patient is enrolled in the MyPRALUENTCoach™ Patient Support Program (the “PSP”);
• Physician provided recent “treated” report of LDL-C >2.4 mmol/L (within 3 months of request date);
• Physician confirmed that patient has been provided nutritional counselling as part of treatment plan;
• Patient is currently maximized on a statin* OR
• Physician confirmed and documented patient contraindication to a statin (e.g. pregnancy, nursing, active liver disease); OR
• Physician confirmed and documented patient intolerance to a statin (myositis, rhabdomyolysis) AND has ruled out the following conditions as possible predisposing factors (drug interactions, untreated hypothyroidism, febrile illness, acute renal failure, biliary obstruction, alcoholism) AND the patient has trialed and failed at least 2 different statins, one of which is at the lowest dose with a re-challenge.

Renewals:

Initial (Year 1): Physician has provided recent LDL-C report demonstrating a minimum 40% reduction in the patient’s LDL-C after 12 week trial on Praluent™ (up to maximum of 24 weeks of use) and a demonstrated statin adherence as per Medavie Blue Cross’ internal metric.

Subsequent: Subsequent annual renewals will require that the patient is continuing to derive clinical benefit from the drug and has demonstrated statin adherence as per Medavie Blue Cross’ internal metric.

Requests for special authorization are considered as monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability.

Requests for special authorization are considered in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

A validated test is required to confirm the FLT3 mutation status of AML.

Requests for Special Authorization are considered for:

• Patients 12 years of age and older and diagnosed with moderate-to severe atopic dermatitis
• Being treated by a dermatologist, or in consultation with a dermatologist
• With Physician’s Global Assessment (PGA) score of 3 or higher (moderate-to-severe on a scale of 0–4) AND a body surface area (BSA) of 10% or higher
• Who have previously tried and failed (or been intolerant to) phototherapy if indicated and accessible
• And have previously tried and failed (or been intolerant to) medium-potency to high-potency topical corticosteroids AND topical calcineurin inhibitors
• Patient is enrolled in the patient support program (Freedom)

Renewal: Patient is continuing to derive clinical benefit from the drug (PGA score ≤1 & at least a 20% decrease in BSA from baseline)

Requests for special authorization are considered for the treatment of the signs and symptoms of dry eye disease.

Requests for special authorization are considered for adult patients with inadequately controlled type 2 diabetes mellitus, who have had a trial of both metformin and at least one sulfonylurea

Requests for special authorization are considered for:

- use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis.

- the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies.

- reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate.

- reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (corticosteroid and/or aminosalicylate and/or an immunosuppressant).

- treatment of fistulising Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment.

- reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and reduction or elimination of corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).

- reduction of signs and symptoms, induction and maintenance of clinical remission, and induction of mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).

- reduction of signs and symptoms, induction of major clinical response, and inhibition of the
progression of structural damage of active arthritis, and improvement in physical function in patients with psoriatic arthritis.

- treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy.

Requests for special authorization are considered for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Requests for special authorization are considered for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus in combination with:

- metformin,
- a sulfonylurea (alone or with metformin)
- pioglitazone (alone or with metformin),
- a basal insulin (alone or with metformin),
when the therapy listed above does not provide adequate glycemic control.

Requests for Special Authorization are considered for:

Requests for Special Authorization are considered for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have:

- genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor;

- genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

Requests for special authorization are considered for:

- for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.

- for the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity.

Requests for special authorization are considered for the management of opioid dependence in patients clinically stabilized on no more than 8 mg of sublingual buprenorphine in combination with counseling and psychosocial support.

Requests for special authorization are considered as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m2 or greater (obese) or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., controlled hypertension, type 2 diabetes mellitus, or dyslipidemia).

Requests for special authorization are considered for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs.

Requests for special authorization are considered for the prophylaxis of cytomegalovirus (CMV) infection in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Requests for special authorization are considered in combination with:

- an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy;

In pre/perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

- fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

Requests for special authorization are considered for the treatment of human immunodeficiency virus (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per mL).

Requests for special authorization are considered for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Requests for special authorization are considered for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with no known substitution associated with resistance to the individual components of BIKTARVY.

Requests for special authorization are considered for the treatment of moderate to severe pain associated with endometriosis.

Requests for special authorization are considered as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin.

Requests for special authorization are considered in combination with methotrexate (MTX), for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Requests for Special Authorization are considered for:

- the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).

- for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

Requests for Special Authorization will be considered:

- as a monotherapy treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).

- as a monotherapy for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

Requests for special authorization are considered in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.

Requests for Special Authorization are considered for:

- the first-line treatment of adult patients with unresectable hepatocellular carcinoma (HCC).

- in combination with pembrolizumab, for the treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC with no prior systemic therapy for metastatic RCC.

Requests for special authorization will be considered for use in adults for the treatment of:

- Invasive aspergillosis

- Invasive mucormycosis

Requests for special authorization are considered for the treatment of:

- adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

- adult patients with active psoriatic arthritis. Skyrizi can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

- the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response, intolerance, or demonstrated dependence to corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies.

Requests for special authorization are considered for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents 12 years of age and older and weighing at least 40 kg.

Requests for special authorization will be considered as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing “off” episodes while on a stable dose of levodopa.

Requests for special authorization will be considered for treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture.

Requests for special authorization are considered as an adjunct to lifestyle modifications, for the once-daily treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with metformin, with or without sulfonylurea, when these combined with basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily), do not provide adequate glycemic control.

Requests for special authorization will be considered for the management of moderate to severe opioid use disorder in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing product.

Requests for special authorization will be considered for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Requests for Special Authorization are considered:

- in combination with methotrexate is indicated in adult patients to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

- in combination with glucocorticoids for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

Requests for Special Authorization are considered for add-on maintenance treatment of adult patients with severe eosinophilic asthma.

Requests for Special Authorization are considered for the topical treatment of psoriasis vulgaris in adults for up to 4 weeks.

Requests for Special Authorization are considered for:

• the treatment of schizophrenia in patients who have tried and failed therapy with Seroquel® or Risperdal® , or have a medical reason why Risperdal or Seroquel can't be used.
• for the treatment of schizophrenia in adolescents 15 17 years of age.
• for the acute treatment of manic or mixed episodes in bipolar I disorder as monotherapy in adolescent patients 13 - 17 years of age.

Requests for Special Authorization are considered for:

- acute and maintenance treatment of schizophrenia in stabilized adult patients.
- for the maintenance monotherapy treatment of bipolar I disorder in adult patients.

Requests for special authorization are considered for:

- the prophylaxis and chronic treatment of asthma in adult and pediatric patients 12 years of age and older, when the client has been treated with an optimal dose of inhaled steroids that does not control symptoms

- the prophylaxis and chronic treatment of asthma in adult and pediatric patients 12 years of age and older, when the client is unable to use inhaled corticosteroids.

Requests for special authorization for Actemra are considered for:

Rheumatoid Arthritis:
- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:
- Diagnosis of moderate to severe rheumatoid arthritis AND:
The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:
- The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

Systemic Juvenile Idiopathic Arthritis:
· for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with one or more non steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, and methotrexate

Polyarticular Juvenile Idiopathic Arthritis:
- for the treatment of signs and symptoms of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have responded inadequately to previous therapy with DMARDs and systemic corticosteroids.

Giant Cell Arteritis (GCA) [SC formulation only]
- for the treatment of giant cell arteritis (GCA) in adult patients.

Requests for special authorization for Actonel will be considered for:

- the treatment of osteoporosis in postmenopausal women and men who are deemed at high risk of fracture based on any one of the following:
-Prior fragility fracture after age 40, including asymptomatic vertebral fractures identified on X-rays
-Current use of oral corticosteroids (any dose)
-BMD report indicating high ten year fracture risk (defined as > 20%) who are deemed at moderate risk of fracture based on BMD report, with at least one of the following compelling reasons to warrant treatment:
-Lumbar spine T-score much lower than femoral neck T-score (at least a difference of one full standard deviation)
-Rapid bone density loss ( 4% in the past year)
-Men receiving androgen-deprivation therapy for prostate cancer
-Women receiving aromatase-inhibitor therapy for breast cancer
-Repeated corticosteroid use (oral or parenteral) in last two years, even if patient is not currently on corticosteroid.
-Recurrent falls (2 or more in the past year)
-treatment of Paget's disease of the bone in individuals who are symptomatic or with alkaline phosphatase level of at least two times the upper limit of normal

Requests for special authorization are considered for:

- the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

- the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

Requests for Special Authorization are considered for
for clients who have a diagnosis of:
a) primary (idiopathic) pulmomary arterial hypertension, OR
b) pulmonary arterial hypertension associated with other disease in patients with WHO functional II or III symptoms who have not responded to conventional therapy.

Requests for special authorization will be considered for:
- inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4)
- persistent or recurrent CTEPH after surgical treatment
- pulmonary arterial hypertension (PAH, WHO Group 1), as monotherapy or in combination with endothelin receptor antagonists

Requests for special authorization are considered for:

- patients for the prophylaxis of organ rejection and for the treatment of refractory rejection in patients receiving liver or kidney transplants.

Requests for special authorization will be considered for patients not adequately controlled with a regular benefit inhaled corticosteroid/long-acting beta2-adrenergic agonist combination product.

Note: Advair Diskus and generics are regular benefits.

Requests for special authorization will be considered for:

- the treatment of postmenopausal women with hormone receptor-positive, HER2- negative advanced breast cancer in combination with exemestane after recurrence or progression following treatment with letrozole or anastrozole.

- the treatment of patients with metastatic renal cell carcinoma (RCC) of clear cell morphology, after failure of initial treatment with either of the VEGF-receptor TKIs3 sunitinib or sorafenib.

- for the treatment of well- or moderately differentiated neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease that has progressed within the last 12 months.

- for the treatment of unresectable, locally advanced or metastatic, welldifferentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults with progressive disease.

Requests for special authorization are considered for patients who have a diagnosis of: -chronic essential thrombocythemia,
-or thrombocythemia secondary to a myeloproliferative disorder.

Requests for special authorization will be considered for clients who suffer from narcolepsy or obstructive sleep apnea/hypopnea syndrome (OSAHS. Requests for fatigue caused by other medical conditions will only be considered on an exceptional basis and must include diagnosis, other medications tried and response to treatment, expected duration of therapy, and any other information that will support reimbursement of the drug on an individual consideration basis.

Requests for special authorization are considered for:

- patients who have a documented allergy resulting in anaphylactic reactions.

Requests for special authorization for Aloxi are considered for:

- patients receiving highly emetogenic or moderately emetogenic cancer chemotherapy

Requests for special authorization are considered for:

- patients who have a definite diagnoses of migraine AND have failed to respond to first-line abortive therapy (e.g. NSAIDs and standard analgesic therapy), unless contraindicated.

Requests for Special Authorization are considered for patients diagnosed with chronic plaque psoriasis, and is being treated initially by a dermatologist, or in consultation with a dermatologist, or a specialist, such as Internal Medicine AND Patient has involvement in equal to or more than 10% body surface area. If the area is less than 10%, disabling psoriasis due to anatomic location (i.e., scalp, palmar, foot, or groin involvement) will allow the patient to qualify in the same manner as equal to or more than 10% AND Patient has failed systemic therapy with methotrexate. cyclosporine, or acitretin (Soriatane); AND Patient has failed photochemical therapy AND Patient is at least 16 years of age AND If this is a renewal, a 12 week interval has passed since completion of the last treatment course.

Requests for special authorization will be considered for patients who have failed or are intolerant to regular benefit testosterone preparations unless they are unsuitable for the patient’s condition.

Requests for special authorization will be considered for patients who have failed or are intolerant to regular benefit testosterone preparations unless they are unsuitable for the patient’s condition.

Requests for Special Authorization are considered for:
patients suffering from unacceptable adverse effects due to other estrogen therapy (e.g. estrogen-induced hypertension or migraine), or patients who have not had symptom relief with other hormone replacement therapy.

Requests for special authorization are considered for:

- Adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.

- Monotherapy in the management of partial-onset seizures in adult patients with epilepsy.

Requests for special authorization are considered for: a) clients suffering from anemia associated with chronic renal failure (CRF). b) the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitantly asministered chemotherapy. Requests for Aranesp treatment prior to an elective-surgical procedure will not be approved.

Requests for special authorization is considered for:

- patients diagnosed with Alzheimer's disease or Lewy Body disease of mild to moderate severity.

For approval purposes, mild to moderate severity corresponds to a Mini Mental State Exam (MMSE) score of 10 to 26 inclusively.

In advanced Alzheimer's, there is no evidence that the use of this product is beneficial and therefore the product is not a benefit. Cases of early-onset dementia (< than 60 years of age) require assessment by a neurologist or geriatrician before this product can be considered.

Requests for special authorization are considered for HIV- naïve infected patients and in treatment-experienced adult patients who have failed prior antiretroviral therapy.

Requests for special authorization for Avandia™ and Avanadamet™ are considered
For the management of type 2 diabetes in patients for whom all other oral medications, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance.

Requests for special authorization are considered for:

- Patients with a diagnosis of relapsing-remitting multiple sclerosis or RRMS that has progressed to SPMS. The patient must have suffered a minimum of two exacerbations in the previous two years and must be able to walk with or without a walking aid.

- Patlients presenting with a first isolated and well-defined neurologic event as consistent with MS and involving the optic nerve, spinal cord, brain stem or cerebellum. Patients must also have two or more clinically significant lesions of the brain that are at least 3mm in diameter on MRI scans and are characteristic of MS. Patients must also be able to walk with or without a walking aid

- For all requests the diagnosis must be made by a neurologist.

Requests for special authorization will be considered for treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum transferases (ALT or AST) or histologically active disease. Prescribed only by or in consultation with a hepatologist, infectious disease specialist, or gastroenterologist. These requests may include the following:
A. Patients who cannot tolerate lamivudine or for whom lamivudine is
contraindicated, OR
B. Patients with lamivudine-resistant chronic hepatitis B who
have failed on, or relapsed after lamivudine treatment;
have developed viral resistance to lamivudine, OR
C. Patients with severe liver disease who
have decompensated chronic hepatitis B;
have evidence of severe fibrosis or cirrhosis;
are pre- or post-liver transplantation. The recurrence of chronic hepatitis B after
liver transplantation results in increased risk for graft failure and death of patients.
have compensated chronic hepatitis B and are at risk of liver decompensation
(e.g., Chronic Hepatitis B flare, highly replicative HBV), OR
D. Patients with HBV/HIV co-infection who are not on antiviral agents but require HBV treatment only- (treatment should be undertaken in consultation with a hepatologist or infectious
disease specialist)

Requests for special authorization are considered for clients where vaccination is required because of repeated exposure to untreated or inadequately treated active tuberculosis in conditions where usual preventive measures are not possible or have been unsuccessful e.g. in drug resistance AND/OR the client is a health care worker where there is considerable risk of infection AND a registered and qualified professional will be involved in the administration of the vaccine.

Requests for special authorization will be considered for adult patients with moderate-severe autoantibody positive systemic lupus erythematosus (SLE) who have not responded to, have had intolerable toxicity, or a contraindication to corticosteroids and hydroxychloroquine.

Requests for special authorization are considered for:

- Patients with a diagnosis of relapsing-remitting multiple sclerosis or RRMS that has progressed to SPMS. The patient must have suffered a minimum of two exacerbations in the previous two years and must be able to walk with or without a walking aid.

- Patients presenting with a first isolated and well-defined neurologic event as consistent with MS and involving the optic nerve, spinal cord, brain stem or cerebellum. Patients must also have two or more clinically significant lesions of the brain that are at least 3mm in diameter on MRI scans and are characteristic of MS. Patients must also be able to walk with or without a walking aid

-For all requests the diagnosis must be made by a neurologist.

Requests for special authorization are considered for for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy.

Requests for special authorization are considered for:

- patients 12 years of age and older with strabismus or blepharospasm where treatment is currently being provided by an ophthalmologist or internist experienced in the use of botulinum toxin for the above indications.

- adult patients with 7th nerve disorders, cervical dystonia (spasmodic torticollis) or achalasia where treatment is currently being provided by an internist experienced in the use of botulinum toxin for this indication

- patients 2 years of age and older with dynamic equinus foot deformity due to spasticity in pediatric cerebral palsy

- management of hyperhidrosis of the axilla in adult patients who have failed topical antiperspirants and anticholinergic medication or iontophoresis, and treatment is being provided by a dermatologist.

- for the management of focal spasticity, including the treatment of upper limb spasticity associated with stroke in adults

- for the symptomatic treatment of lower limb spasticity associated with stroke in adults

- for prophylaxis of headaches in adult patients with chronic migraine (≥ 15 migraines per month with headaches lasting 4 hours per day or longer) in which treatment with first-line therapy has failed or is inappropriate.

Requests for special authorization are considered for:

- use in combination therapy with methotrexate for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in adult patients, when the following criteria has been met:

(a) Diagnosis of moderate to severe rheumatoid arthritis AND:

The medication must be prescribed by, or in consultation with, a rheumatologist, or a specialist in the field of RA AND:

(b) The patient must have tried and failed a minimum 12 week trial of methotrexate plus one other disease modifying anti-rheumatic drug. Where combinations of non-biologic DMARDs are impossible, 3 consecutive non-biologic DMARDs would be acceptable.

- patients with ankylosing spondylitis who have failed a six-month trial of two different non-steroidal anti-inflammatory drugs (NSAIDS).

Requests for special authorization will be considered for patients not adequately controlled with a regular benefit inhaled corticosteroid/long-acting beta2-adrenergic agonist combination product.

Note: Breo Ellipta 100 mcg/25 mcg is a regular benefit.

Requests for Special Authorization are considered for:

Brilinta, co-administered with low-dose acetylsalicylic acid (ASA: 75-150 mg), for the secondary prevention of atherothrombotic events in:
- Patients with Acute Coronary Syndromes (ACS)
- Patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event

Requests for special authorization will be considered as adjunctive therapy in the management of partial-onset seizures in patients 4 years of age and older with epilepsy who are not satisfactorily controlled with conventional therapy.

Requests for special authorization are considered:

- for patients who have Paget's disease of the bone and have severe pain or evidence of active osteolytic lesions

- to treat hypercalcemia in patients who have cancer, where other measures have been tried and failed to control the hypercalcemia

- to treat pain from recent osteoporotic fracture which can not be relieved by analgesics

Requests for special authorization are considered:

- for patients who have Paget's disease of the bone and have severe pain or evidence of active osteolytic lesions

- to treat hypercalcemia in clients who have cancer, where other measures have been tried and failed to control the hypercalcemia

- to treat pain from recent osteoporotic fracture which can not be relieved by analgesics

Requests for special authorization are considered for the acute treatment of migraine attacks with or without aura in adults 18 years and older.

Requests for special authorization are considered for:

- patients who are presently abstaining from alcohol use and are enrolled in a comprehensive treatment program

Requests for Special Authorization for Caprelsa are considered for the:
treatment of symptomatic or progressive medullary thyroid cancer in adult patients with unresectable locally advanced or metastatic disease

Requests for special authorization are considered for:

- patients with a diagnosis of cystic fibrosis (CF) who have chronic pulmonary Pseudomonas aeruginosa infections and who have tried and failed or do not tolerate treatment with TOBI®

Requests for special authorization are considered for clients who meet the following criteria:

to be used in combination with other antiretroviral agents in treatment experienced adult patients who are infected with CCR5-tropic HIV-1 virus and who have documented resistance to at least one agent from each of the three major classes of antiretroviral agents [nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), protease inhibitors (PI)]

Requests for Special Authorization are considered for the first-line treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.