Updates to the Alberta Drug Benefit List. Effective May 1, 2018

Transcription

1 Updates to the Alberta Drug Benefit List Effective May 1, 2018

2 Inquiries should be directed to: Pharmacy Services Alberta Blue Cross Street NW Edmonton AB T5J 3C5 Telephone Number: (780) (Edmonton) (403) (Calgary) (Toll Free) FAX Number: (780) (Toll Free) 901BWebsite: Hhttp:// Administered by Alberta Blue Cross on behalf of Alberta Health. The Drug Benefit List (DBL) is a list of drugs for which coverage may be provided to program participants. The DBL is not intended to be, and must not be used as a diagnostic or prescribing tool. Inclusion of a drug on the DBL does not mean or imply that the drug is fit or effective for any specific purpose. Prescribing professionals must always use their professional judgment and should refer to product monographs and any applicable practice guidelines when prescribing drugs. The product monograph contains information that may be required for the safe and effective use of the product. Copies of the Alberta Drug Benefit List are available from Pharmacy Services, Alberta Blue Cross at the address shown above. Binder and contents: ( G.S.T.) Contents only: ( G.S.T.) A cheque or money order must accompany the request for copies. ABC 40211/81160 (R2018/05)

3 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Table of Contents Special Authorization... 1 New Drug Product(s) Available by Special Authorization... 1 Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit / Special Authorization... 1 Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Special Authorization... 1 Drug Product(s) with Changes to Criteria for Coverage... 1 Added Product(s)... 2 New Established Interchangeable (IC) Grouping(s)... 3 Least Cost Alternative (LCA) Price Change(s)... 3 Product(s) with a Price Change... 3 Discontinued Listing(s)... 4 Part 2 Drug Additions Part 3 Special Authorization EFFECTIVE MAY 1, 2018

4 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Special Authorization The following drug product(s) will be considered for coverage by Special Authorization for patients covered under Alberta government-sponsored drug programs. Criteria for coverage of Alberta Human Services can be found in the May 1, 2018 Alberta Human Services Drug Benefit Supplement. New Drug Product(s) Available by Special Authorization Trade Name / Strength / Form Generic Description DIN MFR NUCALA 144 MG / VIAL INJECTION MEPOLIZUMAB GSK PHEBURANE 483 MG / G ORAL GRANULE SODIUM PHENYLBUTYRATE MDK RAVICTI 1.1 G / ML ORAL LIQUID GLYCEROL PHENYLBUTYRATE RAP VOSEVI 400 MG / 400 MG / 100 MG SOFOSBUVIR/ VELPATASVIR/ VOXILAPREVIR GIL Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit/ Special Authorization Trade Name / Strength / Form Generic Description DIN MFR JAMP-RIZATRIPTAN ODT 5 MG DISINTEGRATING JAMP-RIZATRIPTAN ODT 10 MG DISINTEGRATING RIZATRIPTAN BENZOATE JPC RIZATRIPTAN BENZOATE JPC Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Special Authorization Trade Name / Strength / Form Generic Description DIN MFR ESBRIET 267 MG ESBRIET 801 MG PIRFENIDONE PIRFENIDONE HLR HLR Drug Product(s) with Changes to Criteria for Coverage Trade Name / Strength / Form Generic Description DIN MFR ACLASTA 0.05 MG / ML INJECTION ZOLEDRONIC ACID NOV DIFLUCAN 10 MG / ML ORAL SUSPENSION FLUCONAZOLE PFI TARO-ZOLEDRONIC ACID 0.05 MG / ML INJECTION ZOLEDRONIC ACID TAR ZOLEDRONIC ACID 0.05 MG / ML INJECTION ZOLEDRONIC ACID DRL EFFECTIVE MAY 1,

5 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Added Product(s) Trade Name / Strength / Form Generic Description DIN MFR APO-PERINDOPRIL 2 MG PERINDOPRIL ERBUMINE APO-PERINDOPRIL 4 MG PERINDOPRIL ERBUMINE APO-PERINDOPRIL 8 MG PERINDOPRIL ERBUMINE AURO-PERINDOPRIL 2 MG PERINDOPRIL ERBUMINE AUR AURO-PERINDOPRIL 4 MG PERINDOPRIL ERBUMINE AUR AURO-PERINDOPRIL 8 MG PERINDOPRIL ERBUMINE AUR MAR-AMLODIPINE 2.5 MG AMLODIPINE BESYLATE MAR MINT-ACITRETIN 10 MG CAPSULE ACITRETIN MPI MINT-ACITRETIN 25 MG CAPSULE ACITRETIN MPI MINT-METFORMIN 500 MG METFORMIN HCL MPI MINT-METFORMIN 850 MG METFORMIN HCL MPI PHARMA-SIMVASTATIN 20 MG SIMVASTATIN PHARMA-SIMVASTATIN 40 MG SIMVASTATIN BENZYDAMINE 0.15% ORAL RINSE BENZYDAMINE HCL PERINDOPRIL 2 MG PERINDOPRIL ERBUMINE PERINDOPRIL 4 MG PERINDOPRIL ERBUMINE PERINDOPRIL 8 MG PERINDOPRIL ERBUMINE SANDOZ PERINDOPRIL ERBUMINE 2 MG SANDOZ PERINDOPRIL ERBUMINE 4 MG SANDOZ PERINDOPRIL ERBUMINE 8 MG PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE PERINDOPRIL ERBUMINE SANDOZ PERINDOPRIL / INDAPAMIDE 4 MG / 1.25 MG SANDOZ PERINDOPRIL / INDAPAMIDE HD 8 MG / 2.5 MG PERINDOPRIL ERBUMINE/ INDAPAMIDE HEMIHYDRATE PERINDOPRIL ERBUMINE/ INDAPAMIDE HEMIHYDRATE TARO-ACITRETIN 10 MG CAPSULE ACITRETIN TAR A-BUDESONIDE MG / ML INHALATION SUSPENSION A-BUDESONIDE 0.5 MG / ML INHALATION SUSPENSION BUDESONIDE BUDESONIDE A-PERINDOPRIL 2 MG PERINDOPRIL ERBUMINE A-PERINDOPRIL 4 MG PERINDOPRIL ERBUMINE EFFECTIVE MAY 1, 2018

6 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Added Product(s), continued Trade Name / Strength / Form Generic Description DIN MFR A-PERINDOPRIL 8 MG PERINDOPRIL ERBUMINE A-PERINDOPRIL / INDAPAMIDE 4 MG / 1.25 MG A-PERINDOPRIL / INDAPAMIDE 8 MG / 2.5 MG PERINDOPRIL ERBUMINE/ INDAPAMIDE HEMIHYDRATE PERINDOPRIL ERBUMINE/ INDAPAMIDE HEMIHYDRATE New Established Interchangeable (IC) Grouping(s) The following IC Grouping(s) have been established and LCA pricing will be applied effective June 1, Generic Description Strength / Form New LCA Price ACITRETIN 10 MG CAPSULE ACITRETIN 25 MG CAPSULE BUDESONIDE MG / ML INHALATION SUSPENSION BUDESONIDE 0.5 MG / ML INHALATION SUSPENSION PERINDOPRIL ERBUMINE 2 MG PERINDOPRIL ERBUMINE 4 MG PERINDOPRIL ERBUMINE 8 MG PERINDOPRIL ERBUMINE/ INDAPAMIDE 4 MG / 1.25 MG PERINDOPRIL ERBUMINE/ INDAPAMIDE 8 MG / 2.5 MG Least Cost Alternative (LCA) Price Change(s) The following established IC Grouping(s) are affected and a revised LCA price has been established. Groupings affected by a Price Decrease, will be effective May 1, Please review the online Alberta Drug Benefit List at for further information. Generic Description Strength / Form New LCA Price BENZYDAMINE HCL 1.5 MG / ML ORAL RINSE Product(s) with a Price Change The following product(s) had a Price Decrease. The previous higher price will be recognized until May 31, For products within an established IC Grouping, the LCA price may apply. Trade Name / Strength / Form Generic Description DIN MFR ODAN-BENZYDAMINE 0.15% ORAL RINSE BENZYDAMINE HCL ODN EFFECTIVE MAY 1,

7 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Product(s) with a Price Change, continued Trade Name / Strength / Form Generic Description DIN MFR PHARIXIA 0.15% ORAL RINSE BENZYDAMINE HCL PPH Discontinued Listing(s) Notification of discontinuation has been received from the manufacturer(s). The Alberta government-sponsored drug programs previously covered the following drug product(s). Effective May 1, 2018, the listed product(s) will no longer be a benefit and will not be considered for coverage by Special Authorization. A transition period will be applied and, as of June 1, 2018 claims will no longer pay for these product(s). Trade Name / Strength / Form Generic Description DIN MFR ACT IRBESARTAN / HCT 300 MG / 12.5 MG ACT IRBESARTAN / HCT 300 MG / 25 MG IRBESARTAN/ HYDROCHLOROTHIAZIDE IRBESARTAN/ HYDROCHLOROTHIAZIDE APH APH ACT RISPERIDONE 0.25 MG RISPERIDONE APH ACT RISPERIDONE 0.5 MG RISPERIDONE APH ACT RISPERIDONE 3 MG RISPERIDONE MYP ACT RISPERIDONE 4 MG RISPERIDONE APH ACT RIZATRIPTAN ODT 10 MG DISINTEGRATING RIZATRIPTAN BENZOATE APH ACT ROSUVASTATIN 40 MG ROSUVASTATIN CALCIUM APH ACT TELMISARTAN 40 MG TELMISARTAN APH APO-CANDESARTAN / HCTZ 16 MG / 12.5 MG APO-CANDESARTAN / HCTZ 32 MG / 12.5 MG APO-CANDESARTAN / HCTZ 32 MG / 25 MG APO-IRBESARTAN / HCTZ 150 MG / 12.5 MG CANDESARTAN CILEXETIL/ HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL/ HYDROCHLOROTHIAZIDE CANDESARTAN CILEXETIL/ HYDROCHLOROTHIAZIDE IRBESARTAN/ HYDROCHLOROTHIAZIDE APO-NITROGLYCERIN 0.4 MG / DOSE SUBLINGUAL METERED DOSE SPRAY NITROGLYCERIN APO-TELMISARTAN / HCTZ 80 MG / 12.5 MG TELMISARTAN/ HYDROCHLOROTHIAZIDE APO-ZOLMITRIPTAN 2.5 MG ZOLMITRIPTAN CO GABAPENTIN 100 MG CAPSULE GABAPENTIN APH CO GABAPENTIN 300 MG CAPSULE GABAPENTIN APH CO GABAPENTIN 400 MG CAPSULE GABAPENTIN APH 4 EFFECTIVE MAY 1, 2018

8 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Discontinued Listing(s), continued Trade Name / Strength / Form Generic Description DIN MFR GABAPENTIN 100 MG CAPSULE GABAPENTIN AHI MAR-METFORMIN 500 MG METFORMIN HCL MAR MESASAL 500 MG ENTERIC-COATED MESALAZINE GSK MYLAN-CLOPIDOGREL 75 MG CLOPIDOGREL BISULFATE MYP MYLAN-DONEPEZIL 10 MG DONEPEZIL HCL MYP MYLAN-LISINOPRIL 20 MG LISINOPRIL MYP MYLAN-MONTELUKAST 5 MG CHEWABLE MONTELUKAST SODIUM MYP MYLAN-RISPERIDONE 0.25 MG RISPERIDONE MYP MYLAN-RISPERIDONE 0.5 MG RISPERIDONE MYP MYLAN-SERTRALINE 25 MG CAPSULE SERTRALINE HCL MYP MYLAN-SERTRALINE 50 MG CAPSULE SERTRALINE HCL MYP MYLAN-VENLAFAXINE XR 37.5 MG EXTENDED-RELEASE CAPSULE MYLAN-VENLAFAXINE XR 75 MG EXTENDED-RELEASE CAPSULE VENLAFAXINE HCL MYP VENLAFAXINE HCL MYP -LORAZEPAM 0.5 MG LORAZEPAM A-PRAMIPEXOLE 0.25 MG PRAMIPEXOLE DIHYDROCHLORIDE EFFECTIVE MAY 1,

9 Drug Additions PART 2 Drug Additions

10 ACITRETIN 10 MG ORAL CAPSULE MINT-ACITRETIN TARO-ACITRETIN SORIATANE 25 MG ORAL CAPSULE MINT-ACITRETIN SORIATANE MPI TAR ACV MPI ACV AMLODIPINE BESYLATE 2.5 MG (BASE) ORAL ACT AMLODIPINE AMLODIPINE JAMP-AMLODIPINE MAR-AMLODIPINE AMLODIPINE SANDOZ AMLODIPINE APH SIV JPC MAR BENZYDAMINE HCL 0.15 % ORAL RINSE ODAN-BENZYDAMINE PHARIXIA BENZYDAMINE ODN PPH BUDESONIDE MG / ML INHALATION SUSPENSION A-BUDESONIDE PULMICORT NEBUAMP 0.5 MG / ML INHALATION SUSPENSION A-BUDESONIDE PULMICORT NEBUAMP AZC AZC FLUCONAZOLE 10 MG / ML ORAL SUSPENSION DIFLUCAN PFI RESTRICTED BENEFIT - This product is a benefit when prescribed by a Specialist in Infectious Diseases or a designated prescriber (Refer to Section 3 - Criteria for Special Authorization of Select Drug Products of the Alberta Drug Benefit List for eligibility when the prescriber prescribing the medication is not a Specialist in Infectious Diseases or a designated prescriber.) UNIT OF ISSUE - REFER TO PRICE POLICY 2. 1 EFFECTIVE MAY 1, 2018

11 METFORMIN HCL 500 MG ORAL ACT METFORMIN APO-METFORMIN AURO-METFORMIN JAMP-METFORMIN METFORMIN METFORMIN FC MINT-METFORMIN MYLAN-METFORMIN METFORMIN RAN-METFORMIN RATIO-METFORMIN HYDROCHLORIDE SANDOZ METFORMIN FC SEPTA-METFORMIN GLUCOPHAGE 850 MG ORAL ACT METFORMIN APO-METFORMIN AURO-METFORMIN JAMP-METFORMIN METFORMIN METFORMIN FC MINT-METFORMIN MYLAN-METFORMIN -METFORMIN RAN-METFORMIN RATIO-METFORMIN HYDROCHLORIDE SANDOZ METFORMIN FC SEPTA-METFORMIN GLUCOPHAGE APH AUR JPC SNS SIV MPI MYP RAN SEP SAV APH AUR JPC SNS SIV MPI MYP RAN SEP SAV PERINDOPRIL ERBUMINE 2 MG ORAL APO-PERINDOPRIL AURO-PERINDOPRIL PERINDOPRIL SANDOZ PERINDOPRIL ERBUMINE A-PERINDOPRIL COVERSYL 4 MG ORAL APO-PERINDOPRIL AURO-PERINDOPRIL PERINDOPRIL SANDOZ PERINDOPRIL ERBUMINE A-PERINDOPRIL COVERSYL 8 MG ORAL APO-PERINDOPRIL AURO-PERINDOPRIL -PERINDOPRIL SANDOZ PERINDOPRIL ERBUMINE A-PERINDOPRIL COVERSYL AUR SEV AUR SEV AUR SEV PRODUCT IS NOT INTERCHANGEABLE 2. 2 EFFECTIVE MAY 1, 2018

12 PERINDOPRIL ERBUMINE/ INDAPAMIDE HEMIHYDRATE 4 MG * 1.25 MG ORAL SANDOZ PERINDOPRIL/INDAPAMIDE A-PERINDOPRIL/INDAPAMIDE COVERSYL PLUS 8 MG * 2.5 MG ORAL SANDOZ PERINDOPRIL/INDAPAMIDE HD A-PERINDOPRIL/INDAPAMIDE COVERSYL PLUS HD SEV SEV RIZATRIPTAN BENZOATE RESTRICTED BENEFIT - This product is a benefit for patients 18 to 64 years of age inclusive for the treatment of acute migraine attacks in patients where standard therapy has failed. (Refer to Criteria for Special Authorization of Select Drug Products of the List for eligibility in patients 65 years of age and older; and Criteria for Special Authorization of Select Drug Products of the Alberta Human Services Drug Benefit Supplement for eligibility in Alberta Human Services clients.) 5 MG (BASE) ORAL DISINTEGRATING ACT RIZATRIPTAN ODT APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT A-RIZATRIPTAN ODT MAXALT RPD 10 MG (BASE) ORAL DISINTEGRATING APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT -RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT A-RIZATRIPTAN ODT VAN-RIZATRIPTAN ODT MAXALT RPD APH JPC MYP NTP SNS SIV MFC JPC MYP NTP SNS SIV VAN MFC UNIT OF ISSUE - REFER TO PRICE POLICY 2. 3 EFFECTIVE MAY 1, 2018

13 SIMVASTATIN 20 MG ORAL APO-SIMVASTATIN AURO-SIMVASTATIN JAMP-SIMVASTATIN MAR-SIMVASTATIN MINT-SIMVASTATIN MYLAN-SIMVASTATIN PHARMA-SIMVASTATIN SIMVASTATIN RAN-SIMVASTATIN SIMVASTATIN SIMVASTATIN A-SIMVASTATIN ZOCOR 40 MG ORAL APO-SIMVASTATIN AURO-SIMVASTATIN JAMP-SIMVASTATIN MAR-SIMVASTATIN MINT-SIMVASTATIN MYLAN-SIMVASTATIN PHARMA-SIMVASTATIN -SIMVASTATIN RAN-SIMVASTATIN SIMVASTATIN SIMVASTATIN A-SIMVASTATIN ZOCOR AUR JPC MAR MPI MYP RAN SNS SIV MFC AUR JPC MAR MPI MYP RAN SNS SIV MFC PRODUCT IS NOT INTERCHANGEABLE 2. 4 EFFECTIVE MAY 1, 2018

14 Special Authorization PART 3 Special Authorization

15 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS FLUCONAZOLE (Refer to Section 1 - Restricted Benefits of the Alberta Drug Benefit List for coverage of the product when prescribed by a Specialist in Infectious Diseases or a designated prescriber.) "For susceptible infections in patients who cannot swallow tablets."* *Special Authorization is only required when the prescriber prescribing the medication is not a Specialist in Infectious Diseases or a designated prescriber. 10 MG / ML ORAL SUSPENSION DIFLUCAN PFI GLYCEROL PHENYLBUTYRATE "For chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. For coverage, this drug must be prescribed by or in consultation with a metabolic or genetic physician. The diagnosis must be confirmed by blood, enzymatic, biochemical, or genetic testing. Special authorization may be granted for 12 months." The following product(s) are eligible for auto-renewal. 1.1 G / ML ORAL LIQUID RAVICTI RAP UNIT OF ISSUE - REFER TO PRICE POLICY 3. 1 EFFECTIVE MAY 1, 2018

16 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS MEPOLIZUMAB "Special authorization coverage may be provided for add-on maintenance treatment of adult patients with severe eosinophilic asthma if the following clinical criteria and conditions are met: Patient is inadequately controlled with high-dose inhaled corticosteroids (ICS) and one or more additional asthma controller(s) (e.g., a long-acting beta-agonist [LABA]). AND Patient has a blood eosinophil count of greater than or equal to 150 cells/mcl at initiation of treatment with mepolizumab or greater than or equal to 300 cells/mcl in the 12 months prior to treatment initiation. AND One of the following are met: 1) Patient has experienced two or more clinically significant asthma exacerbations* in the 12 months prior to treatment initiation and shows reversibility (of at least 12% and 200 ml in FEV1) on pulmonary function tests (i.e., spirometry). OR 2) Patient is treated with daily oral corticosteroids (OCS). For coverage, the drug must be initiated and monitored by a respirologist or clinical immunologist or allergist. Initial coverage may be approved for 12 months of 100 mg administered every 4 weeks. -Patients will be limited to receiving a one-month supply of mepolizumab per prescription at their pharmacy. -Patients will be permitted to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period). -Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy. -Coverage cannot be provided for mepolizumab when this medication is intended for use in combination with other biologics for the treatment of asthma. If the following criteria are met, special authorization may be approved for 100 mg administered every 4 weeks for a further 12-month period. Continued coverage may be considered if the following criteria are met at the end of each additional 12-month period: 1) A reduction in the number of clinically significant exacerbations* compared to the 12 months prior to initiation of treatment with mepolizumab. OR 2) A decrease in the maintenance OCS dose of at least 25% from pre-treatment baseline. * Clinically significant asthma exacerbation is defined as worsening of asthma such that the treating physician elected to administer systemic glucocorticoids for at least 3 days or the patient visited an emergency department or was hospitalized." All requests (including renewal requests) for mepolizumab must be completed using the Mepolizumab Special Authorization Request Form (ABC 60061). 144 MG / VIAL INJECTION NUCALA GSK PRODUCT IS NOT INTERCHANGEABLE 3. 2 EFFECTIVE MAY 1, 2018

17 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS PIRFENIDONE "Initial approval criteria: Adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF): - Diagnosis confirmed by a respirologist and a high-resolution CT scan within the previous 24 months. -All other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded. - Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted. - Patient is under the care of a physician with experience in IPF. Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests) Initial renewal criteria (at 6 months): Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of greater than or equal to 10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. Approval period: 6 months Second and subsequent renewals (at 12 months and thereafter): Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of greater than or equal to 10% within any 12 month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. Approval period: 12 months Exclusion Criteria: Combination use of pirfenidone and nintedanib will not be funded. Notes: Patients who have experienced intolerance or failure to pirfenidone or nintedanib will be considered for the alternate agent provided that the patient continues to meet the above coverage criteria." All requests for pirfenidone must be completed using the Nintedanib/Pirfenidone Special Authorization Request Form (ABC 60051). 267 MG ORAL ESBRIET 801 MG ORAL ESBRIET HLR HLR UNIT OF ISSUE - REFER TO PRICE POLICY 3. 3 EFFECTIVE MAY 1, 2018

18 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS RIZATRIPTAN BENZOATE (Refer to 28:32.28 of the Alberta Drug Benefit List for coverage of patients 18 to 64 years of age inclusive.) "For the treatment of acute migraine attacks in patients 65 years of age and older where other standard therapy has failed." "For the treatment of acute migraine attacks in patients 65 years of age and older who have been using rizatriptan benzoate prior to turning 65." "Special authorization for both criteria may be granted for 24 months." In order to comply with the first criteria, information is required regarding previous medications utilized and the patient's response to therapy. The following product(s) are eligible for auto-renewal. 5 MG (BASE) ORAL DISINTEGRATING ACT RIZATRIPTAN ODT APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT A-RIZATRIPTAN ODT MAXALT RPD 10 MG (BASE) ORAL DISINTEGRATING APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT -RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT A-RIZATRIPTAN ODT VAN-RIZATRIPTAN ODT MAXALT RPD APH JPC MYP NTP SNS SIV MFC JPC MYP NTP SNS SIV VAN MFC SODIUM PHENYLBUTYRATE "As adjunctive therapy in the chronic management of urea cycle disorders (UCDs) involving deficiencies of carbamoyl phosphate synthetase 1, ornithine transcarbamylase, or argininosuccinate synthetase, in patients with neonatal-onset presentation, and patients with late-onset disease who have a history of hyperammonemic encephalopathy. For coverage, this drug must be prescribed by or in consultation with a metabolic or genetic physician. The diagnosis must be confirmed by blood, enzymatic, biochemical, or genetic testing. Special authorization may be granted for 12 months." The following product(s) are eligible for auto-renewal. 483 MG / G ORAL GRANULE PHEBURANE MDK PRODUCT IS NOT INTERCHANGEABLE 3. 4 EFFECTIVE MAY 1, 2018

19 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS SOFOSBUVIR/ VELPATASVIR/ VOXILAPREVIR "For treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; AND II) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6 or mixed genotypes and have previously been treated with a CHC antiviral drug regimen containing a non-structural protein 5A (NS5A) inhibitor; OR Laboratory confirmed hepatitis C genotype 1, 2, 3, 4 and have previously been treated with a CHC antiviral drug regimen containing sofosbuvir without an NS5A inhibitor; AND III) Laboratory confirmed quantitative HCV RNA value within the last 6 months; AND IV) Fibrosis (2) stage of F0 or greater (Metavir scale or equivalent). Duration of therapy reimbursed: - Treatment-experienced, without cirrhosis or with compensated cirrhosis (3): 12 weeks Exclusion criteria: - Patients currently being treated with another HCV antiviral agent Notes: 1. Treatment-experienced is defined as those who have previously been treated with a CHC antiviral drug regimen. 2. Fibrosis score test is optional. Acceptable methods include liver biopsy, transient elastography (FibroScan), fibrotest and serum biomarker panels (such as AST-to-Platelet Ratio Index or Fibrosis-4 score) either alone or in combination. 3. Compensated cirrhosis is defined as cirrhosis with Child-Turcotte-Pugh A (i.e. score 5 to 6). 4. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations." All requests for sofosbuvir/velpatasvir/voxilaprevir must be completed using the Antivirals for Chronic Hepatitis C Special Authorization Request Form (ABC 60022). 400 MG * 100 MG * 100 MG ORAL VOSEVI GIL UNIT OF ISSUE - REFER TO PRICE POLICY 3. 5 EFFECTIVE MAY 1, 2018

20 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS ZOLEDRONIC ACID Osteoporosis: "For the treatment of osteoporosis in patients who have: A high 10-year risk (i.e., greater than 20%) of experiencing a major osteoporotic fracture, OR A moderate 10-year fracture risk (10-20%) and have experienced a prior fragility fracture; AND at least one of the following: 1) For whom oral bisphosphonates are contraindicated due to an abnormality of the esophagus which delays esophageal emptying; OR 2) Who have demonstrated persistent severe gastrointestinal intolerance to a course of therapy with either alendronate or risedronate; OR 3) Who had an unsatisfactory response (defined as a fragility fracture despite adhering to oral alendronate or risedronate treatment fully for 1 year and evidence of a decline in BMD below pre-treatment baseline level). Note: The fracture risk can be determined by the World Health Organization's fracture risk assessment tool, FRAX, or the most recent (2010) version of the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) table. Special Authorization may be granted for 12 months. -Patients will be limited to receiving one dose of zoledronic acid per prescription at their pharmacy. -Coverage cannot be provided for two or more osteoporosis medications (alendronate, denosumab, raloxifene, risedronate, zoledronic acid) when these medications are intended for use as combination therapy. -Requests for other osteoporosis medications covered via special authorization will not be considered until 6 months after the last dose of denosumab 60 mg/syr injection syringe. -Requests for other osteoporosis medications covered via special authorization will not be considered until 12 months after the last dose of zoledronic acid 0.05 mg/ml injection." -This product is eligible for auto-renewal for the treatment of osteoporosis. All requests for zoledronic acid for osteoporosis must be completed using the Denosumab/Zoledronic Acid for Osteoporosis Special Authorization Request Form (ABC 60007). Paget's Disease: "For the treatment of Paget's disease. Special Authorization for this criterion may be granted for one dose per 12 month period." "Coverage cannot be provided for two or more medications used in the treatment of PRODUCT IS NOT INTERCHANGEABLE 3. 6 EFFECTIVE MAY 1, 2018

21 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS ZOLEDRONIC ACID Paget's disease when these medications are intended for use in combination or when therapy with two or more medications overlap." 0.05 MG / ML INJECTION TARO-ZOLEDRONIC ACID ZOLEDRONIC ACID ACLASTA TAR DRL NOV UNIT OF ISSUE - REFER TO PRICE POLICY 3. 7 EFFECTIVE MAY 1, 2018