Specialty drugs and approval guidelines_nov2013_empire

Special Authorization Drugs and Approval Guidelines
(Special authorization drugs may vary depending on plan)
For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months, AND who have tried and failed Cimzia or Enbrel or Humira or Simponi For pediatric patients (between ≥ 2 and ≤ 16 years of age) with a confirmed diagnosis of sJIA with fever (>38oC) for at least 2 weeks AND at least ONE of the following symptoms: rash of systemic JIA, serositis, lymphadenopathy, hepatomegaly, splenomegaly AND who have not adequately responded to NSAIDS, corticosteroids and at least a 3 month trial of methotrexate Coordinate with provincial government program For patients with a confirmed diagnosis of pulmonary arterial hypertension functional class II or III Failure to conventional therapy (including calcium channel blockers, anticoagulation with warfarin to maintain INR 1.5-2.5, loop diuretics, digoxin, supplemental oxygen) Coordinate with provincial government program For patients with a confirmed diagnosis of metastatic renal cell carcinoma of clear cell morphology who have tried and failed initial treatment with either For treatment of well- or moderately differentiated PNET in patients with unresectable, locally advanced Coordinate with provincial government program For patients who have tried at least one anti-retroviral from each of the following sub-classes: Nucleoside Reverse Transcriptase Inhibitors (NRTI), Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTI) and Protease Inhibitors (PI) Coordinate with provincial government program For patient with chronic renal failure undergoing For patient with anemia secondary to chemotherapy Coordinate with provincial government program Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. Coordinate with provincial government program For chronic hepatitis B patients who develop resistance to Lamivudine AND who have tried and failed combination therapy with lamivudine/adefovir or For chronic hepatitis B patients who have severe liver For adult patients (≥ 18 years old) with moderate-severe SLE being treated by a rheumatologist Patient must be autoantibody positive (within last 3 months) i.e. ANA or dsDNA positive with SELENA- SLEDAI score ≥ 6 who have tried and failed or are intolerant to corticosteroid and hydroxychloroquine Renewal based on achieving/maintain a SELENA-SLEDAI reduction of 4 points or more Coordinate with provincial government program For the treatment of blepharospasm and strabismus in patients 12 years of age or older For the treatment of torticollis in adult patients For spasticity and other approved clinical conditions For axillary hyperhidrosis in patients that have failed OR are intolerant to an aluminum chloride preparation For the prophylaxis of headaches in adults with chronic migraines (≥ 15 per month with headaches lasting 4 hours a day or longer) who have tried and failed symptomatic (i.e. opioid and non-opioid analgesics, tryptans or ergots) and prophylactic treatment (tricyclic analgesics, antiepileptic drugs or beta blockers) For the treatment of symptomatic or progressive For patients with unresectable locally advanced or metastatic MTC that have enrolled with the CAPRELSA Restricted Distribution Program Coordinate with available provincial plans unresectable or locally advanced or metastatic disease For patients with confirmed Cystic Fibrosis and pulmonary infection with Pseudomonas aeruginosa, who have tried and failed or did not tolerate prior Co-ordinate with provincial programs where possible The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For patients who have tried at least one anti-retroviral from each of the following sub-classes: Nucleoside Reverse Transcriptase Inhibitors (NRTI), Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTI) and Protease Inhibitors (PI) Coordinate with provincial government program For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months Coordinate with provincial government program Coordinate with provincial government program For individuals with advanced Parkinson’s disease and who have tried and failed other oral therapies for control of severe, disabling motor fluctuations Individuals are being screened and managed by specialists and at appropriate centers where the individuals have responded to the drug during the test Coordinate with provincial government program For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months For patients ages 4 to 17 with a confirmed diagnosis of juvenile arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 For patients with a confirmed diagnosis of psoriatic arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide or Sulfasalazine for a period of 3 months For patients with confirmed diagnosis of active ankylosing spondylitis where symptoms are uncontrolled by NSAIDS and the BASDAI score is For patients who are 18 years and older with moderate to severe chronic plaque psoriasis with at least 10% body involvement AND who have tried and failed phototherapy AND have tried and failed or are intolerant to at least 2 systemic therapies AND who are being treated by a dermatologist, AND who have tried and failed Humira or Stelara Coordinate with provincial government program For patient with chronic renal failure undergoing For patient with anemia secondary to chemotherapy Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For patient with histologically confirmed diagnosis of metastatic or locally advanced basal cell carcinoma Whose condition is inappropriate for surgical Coordinate with provincial government program For patient with a confirmed diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF) as confirmed by clinical chest radiology (HRCT) or a lung biopsy who are ineligible for lung transplantation and where pulmonary rehabilitation and supportive care (including oxygen therapy) has not adequately controlled symptoms. Coordinate with available provincial programs For treatment of chronic iron overload in transfusion-dependent anemias for patients diagnosed with low-risk myelodysplastic syndrome (MDS) or other rare anemias, who have tried and failed or are intolerant to deferoxamine. For treatment of chronic iron overload in transfusion- dependent anemias, in children 2-5 years of age diagnosed with an inherited haemoglobin disorder (B-thalassemia, sickle cell disease), who cannot be adequately treated with deferoxamine Coordinate with provincial government program Coordinate with provincial government program For patients diagnosed with Multiple Sclerosis with Coordinate with available provincial plans An initial 6 weeks of Fampyra will be approved Demonstrates a noted improvement in walking speed from baseline based on one of the following clinical tools (e.g. T25FW, Timed Up and Go, MSWS012, Two Minute Walk) Second-line treatment for patients who have failed treatment with or have had intractable side-effects to The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For patients who have failed first-line treatment and meet the following criteria: Provincial cancer drug coverage is not available for Fludarabine oral tablet in the province where the Applicant has first tried I.V. / infusion Fludarabine and has developed intolerance or adverse effects to this formulation Severe osteoporosis where patient has a bone scan of less than -3.5 SD AND a history of non-trauma related Severe osteoporosis where patient has a bone scan of less than -1.5 SD and a minimum of 3 months of sustained systemic glucocorticoid therapy For patients who have tried at least one anti-retroviral from each of the following sub-classes: Nucleoside Reverse Transcriptase Inhibitors (NRTI), Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTI) and Protease Inhibitors (PI) Coordinate with provincial government program Diagnosis of relapsing remitting multiple sclerosis Failure or intolerance to one or more therapies for multiple sclerosis treatments i.e. Avonex, Betaseron, Copaxone, Extavia, Rebif, Tysabri Coordinate with provincial government program For the treatment of newly diagnosed, Philadelphia-chromosome positive, CML in chronic phase For the treatment adult patients with Philadelphia chromosome-positive CML in blast crisis, accelerated phase or chronic phase after failure of interferon-alpha For the treatment of C-Kit positive (CD 117) inoperable Coordinate with provincial government program For chronic hepatitis B patients who develop resistance to Lamivudine or who have severe liver For hepatitis B patients co-infected with HIV who do not require HAART therapy for HIV The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For the treatment of children and adolescents under 17 years of age with endogenous growth hormone deficiency or with renal failure resulting in slowed growth rate For the treatment of patients with Turner’s syndrome under 14 years of age For adolescents/adults who were growth hormone-deficient during childhood and who have GHD syndrome confirmed as an adult. Use of growth For adults who have GHD (GH ≤ 5 mcg/L ) due to multiple hormone deficiencies, as a result of pituitary disease (hypopituitarism); hypothalamic disease; surgery (pituitary gland tumour ablation); radiation For treatment of ISS which is defined as: (i) normal birth weight; (ii) diagnostic evaluation that excludes other known causes of short stature; (iii) height at least 2.25 standard deviation scores below the mean for age and sex; (iv) height velocity below the 25th percentile for bone age; and (v) patients whose epiphyses are not closed Coordinate with provincial government program For patients with fistulizing Crohn’s disease or patients with moderate to severe Crohn’s disease who have failed to respond to corticosteroids AND an immunosuppressant agent (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine) For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months For patients with a confirmed diagnosis of psoriatic arthritis with persistent active disease where the Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide or Sulfasalazine for a For patients with confirmed diagnosis of active ankylosing spondylitis where symptoms are uncontrolled by NSAIDS and the BASDAI score is For patients who are 18 years and older with moderate to severe chronic plaque psoriasis with at least 10% body involvement AND who have tried and failed phototherapy AND have tried and failed or are intolerant to at least 2 systemic therapies AND who are being treated by a dermatologist Coordinate with provincial government program For patients with a confirmed diagnosis Cryopyrin- Associated Periodic Syndromes (CAPS), Familial Cold Autoinflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU, or Muckle-Wells Syndrome Coordinate with available provincial programs AND The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For adults with chronic hepatitis C genotype 1 infection in combination with peginterferon alpha/ribavirin An initial 6 weeks of Incivek will be approved The authorization will be renewed if the HCV-RNA is < 1000 IU/ml at week 4 of Incivek therapy The maximum duration of treatment will be 12 weeks of Incivek therapy Coordinate with available provincial plans For patients who have failed prior systemic therapy For combination antiretroviral therapy in patients who have evidence of resistance to at least one antiretroviral therapy from each of the following sub- classes: Nucleoside Reverse Transcriptase Inhibitors (NRTI), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) and Protease Inhibitors (PI) Coordinate with provincial government program Coordinate with provincial government program For patients who have tried and failed first-line and second-line chemotherapy or are ineligible for second- line therapy. Treatment with platinum compounds and docetaxel must be documented. ECOG performance Coordinate with provincial government program For patients who have tried at least one anti-retroviral from each of the following sub-classes: Nucleoside Reverse Transcriptase Inhibitors (NRTI), Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTI) Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For the treatment of splenomegaly and/or its associated symptoms (weight loss, fever, night sweats, fatigue, bone pain, pruritus, peripheral edema) in adult patients diagnosed with: Primary myelofibrosis (also known as chronic Post-essential thrombocythemia myelofibrosis AND where allogenic stem cell transplantation is deemed inappropriate Coordinate with provincial government program For patients 6 years of age and older diagnosed with mild to moderate cystic fibrosis (i.e. FEV1 ≥ 40%) with a G551D mutation in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene who have tried and failed or are intolerant to standard of care therapies (e.g. tobramycin, dornase alfa, bronchodilators) AND who are being treated by a CF specialist Coordinate with provincial government program For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months, AND who have tried and failed Cimzia or Enbrel or Humira or Simponi Coordinate with provincial government program Diagnosis of hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive Phenylketonuria (PKU) for patients 12 years of age or under Patients must demonstrate responsiveness to 30-day trial and maintain Phe-restrictive diet during treatment Coordinate with provincial government program For patient with a diagnosis of wet AMD AND where For patients with central retinal vein occlusion who For patients with branch retinal vein occlusion who For patients with diabetic macular edema who have Coordinate with provincial government program For patient with a diagnosis of wet AMD AND where Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. Confirmed BRAF V600 mutation positive disease – Coordinate with available provincial plans In combination with G-CSF for NHL and MM patients that are eligible for autologous stem cell patients are predicted to mobilize poorly for the A peak CD34+ circulating cell count of < 15 A history of prior failed mobilization (i.e. Neupogen For patients who require GCSF (Neupogen 300mcg) treatment for more than or equal to 12 consecutive days OR who require GCSF (Neupogen 480mcg) treatment for more than or equal to 8 consecutive days OR have tried and failed and/or had intolerable Co-ordinate with provincial government program Co-ordinate with provincial government program For patients who are refractory or resistant to For patients with advanced hepatocellular carcinoma who are Chid-Pugh Class A and have an ECOG of 0-2 Coordinate with provincial government program For patients with a platelet count ≤ 30 x 109/L and who have had an inadequate response or are intolerant to corticosteroids or immunoglobulins or splenectomy Coordinate with provincial government program For the treatment of children and adolescents under 17 years of age with endogenous growth hormone deficiency or with renal failure resulting in slowed growth rate For the treatment of patients with Turner’s syndrome For adolescents/adults who were growth hormone- deficient during childhood and who have GHD syndrome confirmed as an adult. Use of growth For adults who have GHD (GH ≤ 5 mcg/L ) due to multiple hormone deficiencies as a result of pituitary disease (hypopituitarism), hypothalamic disease, surgery (pituitary gland tumour ablation), radiation therapy, or trauma Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For the treatment of children and adolescents under 17 years of age with endogenous growth hormone deficiency or with renal failure resulting in slowed growth rate For adolescents/adults who were growth hormone- deficient during childhood and who have growth hormone deficiency syndrome confirmed as an adult. Use of growth hormone as a child must be For adults who have GHD (GH ≤ 5 mcg/L ) due to multiple hormone deficiencies, as a result of pituitary disease (hypopituitarism); hypothalamic disease; surgery (pituitary gland tumour ablation); radiation therapy; or trauma. Coordinate with provincial government program For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months, AND who have tried and failed Cimzia or Enbrel or Humira or Simponi For patients ages 6 and older with a confirmed diagnosis of juvenile arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND at least one other DMARD, AND who have tried and failed Enbrel Coordinate with provincial government program For all Hepatitis C patients, an initial 16 weeks will be approved. For genotypes 2 and 3, an additional 8 weeks and for all other genotypes, an additional 32 weeks will be approved if they are responsive to the initial therapy as measured by Early Viral Response For chronic Hepatitis B patients with compensated liver disease, liver inflammation and evidence of viral replication (both cirrhotic and non-cirrhotic disease). An initial 16 weeks will be approved; an additional 32 weeks will be approved if there is response to the initial therapy as measured by HbeAg seroconversion or EVR protocol For patients who have tried at least one anti-retroviral from each of the following sub-classes: Nucleoside Reverse Transcriptase Inhibitors (NRTI), Non- Nucleoside Reverse Transcriptase Inhibitors (NNRTI) Coordinate with provincial government program For treatment in patients, aged 5 years or older, diagnosed with cystic fibrosis and who have a forced The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For patients who are 18 years and older with moderate to severe chronic plaque psoriasis with at least 10% body involvement AND who have tried and failed phototherapy AND have tried and failed or are intolerant to at least 2 systemic therapies AND who are being Coordinate with provincial government program Patients will advanced illness, receiving palliative care, who have tried and failed traditional laxatives and/or For patients with fistulizing Crohn’s disease or patients with moderate to severe Crohn’s disease who have failed to respond to corticosteroids AND an immunosuppressant agent (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine), AND who have tried and failed Humira Patients with active ulcerative colitis who failed or are intolerant to oral corticosteroid therapy AND 5-ASA products AND/OR immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate, or cyclosporine For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months, AND who have tried and failed For patients with a confirmed diagnosis of psoriatic arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide or Sulfasalazine for a period of 3 months, AND who have tried and failed Enbrel or Humira or Simponi For patients with confirmed diagnosis of active ankylosing spondylitis where symptoms are uncontrolled by NSAIDS and the BASDAI score is greater than or equal to 4, AND who have tried and failed Enbrel or Humira or Simponi For patients who are 18 years and older with moderate to severe chronic plaque psoriasis with at least 10% body involvement AND who have tried and failed phototherapy AND who have tried and failed or are intolerant to at least 2 systemic therapies AND who are being treated by a dermatologist, AND who have tried and failed Humira or Stelara Coordinate with provincial government program For the treatment of chronic Non-Infectious Posterior Uveitis in patients who have tried and failed oral prednisone or an equivalent corticosteroid alone and/or an immunosuppressive agent (cyclosporine, azathioprine, The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For patients with a confirmed diagnosis of pulmonary arterial hypertension functional class II or III Failure to conventional therapy (including calcium channel blockers, anticoagulation with warfarin to maintain INR 1.5-2.5, loop diuretics, digoxin, Coordinate with provincial government program For the treatment of refractory or recurrent multiple myeloma, in combination with dexamethasone, in patients who have tried and failed at least two therapies (e.g. Bortezomib, Melphalan and Prednisone, Thalomide) and whose ECOG is of 2 or less. Coordinate with provincial government program For patients who are splenectomized and have tried and failed corticosteroids and immunoglobulins For patients who are non-splenectomized (where surgery is contraindicated) and have tried and failed Maximum approval is 1 year of continuous treatment where therapy should be discontinued thereafter should platelet count exceed 400 x 109/L For the treatment of ALS in patient with symptoms of less than 5 years and still has a vital lung capacity of 60% or more in the absence of tracheotomy For patients who have tried and failed or could not tolerate at least one or more anti-TNF treatment i.e. Coordinate with provincial government program For the treatment of non-hypovolemic hyponatremia patients (e.g. serum sodium < 130 mEq/L or symptomatic hyponatremia) who have tried and failed or are intolerant to standard of care therapies (i.e. fluid restriction, loop diuretics and hypertonic saline) An initial 30 days of Samsca will be approved Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. Adult MS patients with neuropathic pain who have tried other medications such analgesics, opioids, antidepressants or anti-convulsants, with little or no For patients with hyperparathyroidism secondary to CKD with parathyroid hormone levels greater than 33pmol/L For the treatment of HIV wasting associated with catabolism, weight loss or cachexia for patients who are currently on antiretroviral treatment and have tried and Coordinate with provincial government program For patients with a confirmed diagnosis of rheumatoid arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide for a period of 3 months For patients with a confirmed diagnosis of psoriatic arthritis with persistent active disease where the patient has not adequately responded to Methotrexate at a dose equal to or greater than 15 mg/week AND Leflunomide or Sulfasalazine for a period of 3 months For patients with confirmed diagnosis of active ankylosing spondylitis where symptoms are uncontrolled by NSAIDS and the BASDAI score is greater than or equal to 4 Coordinate with provincial government program Coordinate with provincial government program For patients who have tried and failed surgery and/or radiation therapy and other medical therapies OR are ineligible for surgery and/or radiation therapy and other For patients with invasive aspergillosis who have failed or cannot tolerate Amphotericin B or Itraconazole For prophylaxis or prevention of aspergillus or candida infections in patients who have failed or cannot tolerate For treatment of oropharyngeal candidiasis in patients who have failed or cannot tolerate Fluconazole or The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For the treatment of adults with Philadelphia chromosome positive (Ph+) chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib For the treatment of adults with Philadelphia chromosome positive (Ph+) Acute Lymphoblatic Leukemia (ALL),resistant or intolerant to prior therapy Coordinate with provincial government program For patients who are 18 years and older with moderate to severe chronic plaque psoriasis with at least 10% body involvement AND who have tried and failed phototherapy AND have tried and failed or are intolerant to at least 2 systemic therapies AND who are being Coordinate with provincial government program For patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti- VEGF therapy (bevacizumab), and, if KRAS wild type, an anti-EGFR therapy (cetuximab, panitumumab). Coordinate with provincial government program For HIV-infected persons for whom a laboratory test showed an absence of sensitivity or resistance to Non- Nucleoside Reverse Transcriptase (NNRTIs) Coordinate with available provincial government For GIST patients who have tried and failed or had no Diagnosis of metastatic RCC. ECOG of two or less must Coordinate with provincial government program Confirmed BRAF V600 mutation positive disease – Coordinate with available provincial plans The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For patients who have tried and failed first-line and second-line chemotherapy or are ineligible for second- line therapy. Treatment with cisplatin or carboplatin must be documented. ECOG performance status must Maintenance treatment in patients with stable disease after 4 cycles of standard platinum based first line chemotherapy. ECOG performance status must be one Coordinate with provincial government program For treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in For adult patients with accelerated phase Ph+CML resistant to OR intolerant of at least one prior therapy Coordinate with provincial government program Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) Diagnosis of relapsing remitting multiple sclerosis Coordinate with provincial government program For the second-line treatment of glioblastoma multiforme For the treatment of newly diagnosed gioblastoma multiforme concurrently with radiation and post radiation. (10mg-250mg) $8.23-$411.45 (per capsule) For patients ≥ 65 years of age who are not eligible for autologous stem cell transplantation For use in combination with dexamethasone OR Coordinate with provincial government program Patient(s) must have well-differentiated thyroid cancer AND cannot tolerate Thyroid Hormone Suppression The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For management of cystic fibrosis patients, aged 6 years or older, with chronic pulmonary Pseudomonas Diagnosis of severe CHE characterized by fissures, vesicles, bumps, edema, exudation, scaling or lichenification Trial of at least 2 of the following high potency topical steroids: amcinonide (Cyclocort), desoximetasone (Topicort), fluocinonide (Lyderm, Tiamol), betamethasone dipropionate (Diprosone), clobetasol propionate (Clobex) For the treatment of patients with a confirmed diagnosis of pulmonary arterial hypertension functional class III AND who have tried and failed Revatio or Adcirca For the treatment of patients with a confirmed diagnosis of pulmonary arterial hypertension functional class IV Failure to conventional therapy (including calcium channel blockers, anticoagulation with warfarin to maintain INR 1.5-2.5, loop diuretics, digoxin, supplemental oxygen) Coordinate with provincial government program In combination with Xeloda, for the treatment of patients with advanced or metastatic HER2-positive breast cancer who have tried and failed taxanes, anthracyclines Coordinate with provincial government program For RRMS - patients have had an inadequate response to, or are unable to tolerate, other therapies. Patients should have evidence of lesions on their MRI scan, an EDSS value less than 6 and have had at least one For patients with rapidly evolving severe MS, they must have had two or more disabling relapses in one year and at least nine T2-hyperintense lesions in their cranial MRI or at least one gadolinium-enhancing (Gd-enhancing) lesion Coordinate with provincial government program For the treatment of retinitis caused by the cytomegalovirus (CMV) in HIV or immunocompromised For the prevention of CMV disease in solid organ transplant patients at risk (i.e. risk is defined as donor +ve/recipient -ve for CMV, or recipient +ve post-active treatment of CMV disease with IV ganciclovir, or recipient +ve in patients receiving antilymphocyte Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For the treatment of invasive aspergillosis for post- For patients with candidemia who cannot tolerate Amphotericin B and Fluconazole or who have infections with Fluconazole-resistant Candida species Coordinate with provincial government program For adults with chronic hepatitis C genotype 1 infection in combination with peginterferon alpha/ribavirin (Pegetron) Quantitative HCV RNA value from within the last 6 months Fibrosis stage F2 or greater (Metavir scale or equivalent) No diagnosis of cirrhosis OR cirrhosis with a Child Pugh An initial 12 weeks of Victrelis will be approved Renewal Criteria: The authorization will be renewed if the HCV-RNA is ≤ 100 IU/ml at week 8 of Victrelis therapy (week 12 of total treatment) The maximum duration of treatment will be 44 weeks of Victrelis therapy Coordinate with available provincial plans For adults with chronic hepatitis C genotype 1 infection Quantitative HCV RNA value from within the last 6 months Fibrosis stage F2 or greater (Metavir scale or equivalent) No diagnosis of cirrhosis OR cirrhosis with a Child Pugh Score = A (5-6) An initial 12 weeks of Victrelis Triple will be approved The authorization will be renewed if the HCV-RNA is ≤ 100 IU/ml at week 8 of Victrelis Triple therapy (week 12 of total treatment) The maximum duration of treatment will be 44 weeks of Victrelis Triple therapy Coordinate with available provincial plans are not eligible for hematopoietic stem cell transplantation with: Intermediate-2 and High-risk Myelodysplastic Syndrome (MDS) according to the International Acute Myeloid Leukemia (AML) with 20-30 % blasts and multi lineage dysplasia according to World Health Organization (WHO) classification Coordinate with provincial government program For the treatment of age-related macular degeneration in patients with neovascularization of 50% or more on the macular surface AND no provincial coverage is The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. For the treatment of patients with a confirmed diagnosis of pulmonary arterial hypertension functional class II or III AND who have tried and failed Revatio or Adcirca Failure to conventional therapy (including calcium channel blockers, anticoagulation with warfarin to maintain INR 1.5-2.5, loop diuretics, digoxin, supplemental oxygen) Coordinate with provincial government program For patients who have received no prior systemic therapies OR who have documented failure to first line Coordinate with provincial government program Confirmed diagnostic testing of ALK-positive mutation for patients with advanced or metastatic Non-Small Cell For patients who have received prior chemotherapy with Coordinate with available provincial plans For the first-line treatment of metastatic colorectal cancer For the treatment of metastatic colorectal cancer in combination with oxaliplatin after failure of irinotecan- For treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless contraindicated OR in combination with docetaxel after failure of prior anthracycline containing chemotherapy Coordinate with provincial government program For the treatment of blepharospasm in patients 18 years For the treatment of torticollis in adult patients For the treatment of post-stroke spasticity of the upper For patients with a confirmed diagnosis of Dupuytren’s Contracture with a palpable cord AND Who are ineligible or inappropriate for surgical Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors. Moderate to severe asthmatics who are skin test positive or have in-vitro reactivity to a perennial aeroallergen with a baseline IgE level within 30-700IU/ml and who are not adequately controlled by a concomitant therapy of Inhaled Corticosteroids (“ICS”) and Long-Acting Beta- Agonists (“LABA”) and Leukotriene-Recepetor Agonists If use of a previous mentioned drug cannot be used concomitantly, a combination of three of the four following drugs: ICS, LABA, LRA, and/or long-acting Theophylline. For treatment of mCRPC in patients who have received prior chemotherapy containing docetaxel Coordinate with provincial government program Diagnosis of narcolepsy with chronic symptoms of For the treatment of patients 18 years of age and older with mild to moderate Type 1 Gaucher disease for confirmed by laboratory or genetic testing AND for whom enzyme replacement therapy (e.g. Ceredase, Cerezyme, Vpriv) is not a therapeutic option due to constraints such as intolerability, allergy, hypersensitivity, or poor venous To slow the progression of some of the neurological manifestations in patients with Niemann-Pick Type C disease Coordinate with provincial government program Confirmed BRAF V600 mutation positive disease Coordinate with available provincial plans For patients who experience a beneficial clinical effect AND who do not have evidence of disease progression For patients with cutaneous manifestations in patients with advanced CTCL who have progressive, persistent or recurrent disease subsequent to 2 prior systemic therapies (e.g. chemotherapy, interferon, methotrexate) Coordinate with provincial government program For treatment of CRPC in combination with prednisone in patients who have received prior chemotherapy Coordinate with provincial government program The Special Authorization Drugs and Approval Guidelines document may be updated from time to time by the Company. Drugs classified as special authorization may vary amongst plan sponsors.

Source: http://www.empire.ca/docs/pdf/SA-DrugsApprovalGuidelines-EN-web.pdf