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

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1 Updates to the Alberta Drug Benefit List Effective July 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) 109BWebsite: 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 (R2018/07)

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 Restricted Benefit(s)... 2 Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit... 2 Added Product(s)... 2 New Established Interchangeable (IC) Grouping(s)... 2 Product(s) with a Price Change... 2 Discontinued Listing(s)... 3 Part 2 Drug Additions Part 3 Special Authorization EFFECTIVE JULY 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. New Drug Product(s) Available by Special Authorization GLATECT 20 MG / SYRINGE INJECTION GLATIRAMER ACETATE PMS INVEGA TRINZA (0.875 ML) 175 MG / SYRINGE INJECTION INVEGA TRINZA (1.315 ML) 263 MG / SYRINGE INJECTION INVEGA TRINZA (1.75 ML) 350 MG / SYRINGE INJECTION INVEGA TRINZA (2.625 ML) 525 MG / SYRINGE INJECTION PALIPERIDONE PALMITATE JAI PALIPERIDONE PALMITATE JAI PALIPERIDONE PALMITATE JAI PALIPERIDONE PALMITATE JAI Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit/ Special Authorization APO-VARENICLINE 0.5 MG TABLET VARENICLINE TARTRATE APO-VARENICLINE 1 MG TABLET VARENICLINE TARTRATE MAR-RIZATRIPTAN ODT 5 MG ORAL DISINTEGRATING TABLET MAR-RIZATRIPTAN ODT 10 MG ORAL DISINTEGRATING TABLET RIZATRIPTAN BENZOATE MAR RIZATRIPTAN BENZOATE MAR Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Special Authorization CUBICIN RF 500 MG / VIAL INJECTION DAPTOMYCIN CUB MINT-EPLERENONE 25 MG TABLET EPLERENONE MPI MINT-EPLERENONE 50 MG TABLET EPLERENONE MPI Drug Product(s) with Changes to Criteria for Coverage JAMP-VANCOMYCIN 125 MG CAPSULE VANCOMYCIN HCL JAMP-VANCOMYCIN 250 MG CAPSULE VANCOMYCIN HCL EFFECTIVE JULY 1,

5 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Drug Product(s) with Changes to Criteria for Coverage, continued VANCOCIN 125 MG CAPSULE VANCOMYCIN HCL MLI VANCOCIN 250 MG CAPSULE VANCOMYCIN HCL MLI Restricted Benefit(s) Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Restricted Benefit CYCLOBENZAPRINE 10 MG TABLET CYCLOBENZAPRINE HCL SIV PMS-TENOFOVIR 300 MG TABLET TENOFOVIR DISOPROXIL FUMARATE PMS Added Product(s) MINT-HYDRALAZINE 10 MG TABLET HYDRALAZINE HCL MPI MINT-HYDRALAZINE 25 MG TABLET HYDRALAZINE HCL MPI MINT-HYDRALAZINE 50 MG TABLET HYDRALAZINE HCL MPI New Established Interchangeable (IC) Grouping(s) The following IC Grouping(s) have been established and LCA pricing will be applied effective August 1, Generic Description Strength / Form New LCA Price EPLERENONE 25 MG TABLET EPLERENONE 50 MG TABLET VARENICLINE TARTRATE 0.5 MG TABLET VARENICLINE TARTRATE 1 MG TABLET Product(s) with a Price Change The following product(s) had a Price Decrease. The previous higher price will be recognized until July 31, For products within an established IC Grouping, the LCA price may apply. APO-HYDRALAZINE 10 MG TABLET HYDRALAZINE HCL APO-HYDRALAZINE 25 MG TABLET HYDRALAZINE HCL APO-HYDRALAZINE 50 MG TABLET HYDRALAZINE HCL JAMP-HYDRALAZINE 10 MG TABLET HYDRALAZINE HCL EFFECTIVE JULY 1, 2018

6 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Product(s) with a Price Change, continued JAMP-HYDRALAZINE 25 MG TABLET HYDRALAZINE HCL JAMP-HYDRALAZINE 50 MG TABLET HYDRALAZINE HCL 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 July 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 August 1, 2018 claims will no longer pay for these product(s). ACT FINASTERIDE 5 MG TABLET FINASTERIDE APH ACT RAMIPRIL 1.25 MG CAPSULE RAMIPRIL APH ACT RISPERIDONE 1 MG TABLET RISPERIDONE APH ACT VALSARTAN 80 MG TABLET VALSARTAN APH ACT VALSARTAN 320 MG TABLET VALSARTAN APH BELLERGAL SPACETABS 0.2 MG / 0.6 MG / 40 MG SUSTAINED-RELEASE TABLET BELLADONNA/ ERGOTAMINE TARTRATE/ PHENOBARBITAL PAL CYCLOCORT 0.1% TOPICAL CREAM AMCINONIDE GSK MIRAPEX 1 MG TABLET PRAMIPEXOLE DIHYDROCHLORIDE BOE MYLAN-AZITHROMYCIN 250 MG TABLET AZITHROMYCIN MYP MYLAN-DONEPEZIL 5 MG TABLET DONEPEZIL HCL MYP MYLAN-DULOXETINE 30 MG DELAYED-RELEASE CAPSULE MYLAN-DULOXETINE 60 MG DELAYED-RELEASE CAPSULE DULOXETINE HYDROCHLORIDE MYP DULOXETINE HYDROCHLORIDE MYP MYLAN-FAMOTIDINE 40 MG TABLET FAMOTIDINE MYP MYLAN-LOSARTAN HCTZ 50 MG / 12.5 MG TABLET MYLAN-LOSARTAN HCTZ 100 MG / 12.5 MG TABLET MYLAN-LOSARTAN HCTZ 100 MG / 25 MG TABLET LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE MYP MYP MYP MYLAN-OMEPRAZOLE 20 MG DELAYED-RELEASE CAPSULE OMEPRAZOLE MYP MYLAN-ROSUVASTATIN 40 MG TABLET ROSUVASTATIN CALCIUM MYP MYLAN-ZOPICLONE 5 MG TABLET ZOPICLONE MYP EFFECTIVE JULY 1,

7 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Discontinued Listing(s), continued PMS-REPAGLINIDE 0.5 MG TABLET REPAGLINIDE PMS PMS-REPAGLINIDE 1 MG TABLET REPAGLINIDE PMS PMS-REPAGLINIDE 2 MG TABLET REPAGLINIDE PMS TEVA-ENALAPRIL 5 MG TABLET ENALAPRIL MALEATE TEV TEVA-ENALAPRIL 10 MG TABLET ENALAPRIL MALEATE TEV TEVA-ENALAPRIL 20 MG TABLET ENALAPRIL MALEATE TEV TEVA-PRAMIPEXOLE 1 MG TABLET PRAMIPEXOLE DIHYDROCHLORIDE TEV 4 EFFECTIVE JULY 1, 2018

8 Drug Additions PART 2 Drug Additions

9 ALBERTA DRUG BENEFIT LIST UPDATE CYCLOBENZAPRINE HCL RESTRICTED BENEFIT - Coverage is limited to 126 tablets per plan participant per year as an adjunct to rest and physical therapy for the treatment of acute muscle spasm. 10 MG ORAL TABLET APO-CYCLOBENZAPRINE AURO-CYCLOBENZAPRINE CYCLOBENZAPRINE CYCLOBENZAPRINE JAMP-CYCLOBENZAPRINE MYLAN-CYCLOBENZAPRINE PMS-CYCLOBENZAPRINE TEVA-CYCLOBENZAPRINE AUR SNS SIV MYP PMS TEV HYDRALAZINE HCL 10 MG ORAL TABLET APO-HYDRALAZINE JAMP-HYDRALAZINE MINT-HYDRALAZINE 25 MG ORAL TABLET APO-HYDRALAZINE JAMP-HYDRALAZINE MINT-HYDRALAZINE 50 MG ORAL TABLET APO-HYDRALAZINE JAMP-HYDRALAZINE MINT-HYDRALAZINE MPI MPI MPI The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 2. 1 EFFECTIVE JULY 1, 2018

10 ALBERTA DRUG BENEFIT LIST UPDATE 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 TABLET APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MAR-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT PMS-RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT TEVA-RIZATRIPTAN ODT MAXALT RPD 10 MG (BASE) ORAL DISINTEGRATING TABLET APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MAR-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT PMS-RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT TEVA-RIZATRIPTAN ODT VAN-RIZATRIPTAN ODT MAXALT RPD MAR MYP NTP PMS SNS SIV SDZ TEV MFC MAR MYP NTP PMS SNS SIV SDZ TEV VAN MFC TENOFOVIR DISOPROXIL FUMARATE RESTRICTED BENEFIT - This product is a benefit for the treatment of chronic hepatitis B when prescribed by a Specialist in Internal Medicine or a designated prescriber. 300 MG (BASE) ORAL TABLET APO-TENOFOVIR AURO-TENOFOVIR MYLAN-TENOFOVIR DISOPROXIL PMS-TENOFOVIR TEVA-TENOFOVIR VIREAD AUR MYP PMS TEV GIL VANCOMYCIN HCL 125 MG (BASE) ORAL CAPSULE JAMP-VANCOMYCIN VANCOCIN 250 MG (BASE) ORAL CAPSULE JAMP-VANCOMYCIN VANCOCIN MLI MLI The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. PRODUCT IS NOT INTERCHANGEABLE 2. 2 EFFECTIVE JULY 1, 2018

11 ALBERTA DRUG BENEFIT LIST UPDATE VARENICLINE TARTRATE RESTRICTED BENEFIT - This product is a benefit in patients 18 years of age and older for smoking cessation treatment in conjunction with smoking cessation counseling. Coverage will be granted for a total of 12 weeks." 0.5 MG (BASE) ORAL TABLET APO-VARENICLINE CHAMPIX 1 MG (BASE) ORAL TABLET APO-VARENICLINE CHAMPIX PFI PFI The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 2. 3 EFFECTIVE JULY 1, 2018

12 Special Authorization PART 3 Special Authorization

13 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS DAPTOMYCIN For the treatment of: - Culture confirmed gram-positive infections from sterile sites, specifically Methicillin-resistant Staphylococcus aureus (MRSA), AND - In patients who do not respond to, or exhibit multidrug intolerance to, or allergy to vancomycin, AND - to facilitate patient discharge from hospital where it otherwise would not be possible. This product must be prescribed in consultation with a specialist in Infectious Diseases in all instances. Special Authorization may be granted for 12 months. 500 MG / VIAL INJECTION CUBICIN CUBICIN RF CUB CUB EPLERENONE "For persons suffering from New York Heart Association (NYHA) class II chronic heart failure with left ventricular systolic dysfunction with ejection fraction less than or equal to 35 per cent, as a complement to standard therapy." Special authorization will be granted for 12 months. This product is eligible for auto-renewal. All requests (including renewal requests) for eplerenone must be completed using the Eplerenone/Sacubitril+Valstartan Special Authorization Request Form (ABC 60050). 25 MG ORAL TABLET MINT-EPLERENONE INSPRA 50 MG ORAL TABLET MINT-EPLERENONE INSPRA MPI PFI MPI PFI The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 3. 1 EFFECTIVE JULY 1, 2018

14 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS GLATIRAMER ACETATE 20 MG / SYR INJECTION SYRINGE GLATECT PMS ***Effective July 1, 2018, all new Special Authorization requests for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) for glatiramer-naive patients will be assessed for coverage with Glatect. Copaxone will not be approved for new glatiramer acetate starts for patients with the indication stated above; however, coverage for Copaxone will continue for patients who are currently well maintained on Copaxone as per maintenance coverage criteria. Additionally, patients will not be permitted to switch from Glatect to Copaxone.*** Relapsing Remitting Multiple Sclerosis (RRMS): "Special authorization coverage may be provided for the reduction of the frequency and severity of clinical relapses and reduction of the number and volume of active brain lesions, identified on MRI scans, in ambulatory patients with relapsing remitting multiple sclerosis. Coverage For coverage, this drug must be prescribed by a registered MS Neurologist. A current assessment must be completed by a registered MS Neurologist at every request. To register to become an MS Neurologist please complete the Registration for MS Neurologist Status Form (ABC 60002). Initial Coverage 1) The registered MS Neurologist must confirm a diagnosis of RRMS; 2) The patient must have active disease which is defined as at least two relapses* of MS during the previous two years or in the two years prior to starting an MS disease modifying therapy (DMT). *A relapse is defined as the appearance of new symptoms or worsening of old symptoms, lasting at least 48 hours in the absence of fever, not associated with withdrawal from steroids. Onset of clinical relapses must be separated by a period of at least one month. At least one definite gadolinium-enhancing T1 MRI lesion (not questionable faint enhancement) obtained at least 90 days after initiation of the DMT and at least 90 days before or after a relapse may substitute for one clinical relapse. 3) The patient must be ambulatory with or without aid (The registered MS Neurologist must provide a current updated Expanded Disability Status Scale (EDSS) score less than or equal to 6.5). Coverage may be approved for up to 12 months. Patients will be limited to receiving a one-month supply of glatiramer acetate per prescription at their pharmacy for the first 12 months of coverage. Continued Coverage For continued coverage beyond the initial coverage period, the patient must meet the following criteria: 1) The patient must be assessed by a registered MS Neurologist; 2) The registered MS Neurologist must confirm a diagnosis of RRMS; 3) The registered MS Neurologist must provide a current updated EDSS score. The patient must not have an EDSS score of 7.0 or above sustained for one year or more. Coverage of this drug may be considered in a patient with a sustained EDSS score of 7.0 or above in exceptional circumstances. For MS DMT coverage to be considered, details of the exceptional circumstance must be provided in a letter from the registered MS Neurologist and accompany the Special Authorization Request Form. Continued coverage may be approved for up to 12 months. Patients may receive up to 100 days' supply of glatiramer acetate per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. PRODUCT IS NOT INTERCHANGEABLE 3. 2 EFFECTIVE JULY 1, 2018

15 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS GLATIRAMER ACETATE In order to be eligible for coverage, after an interruption in therapy greater than 12 months, the patient must meet the following criteria: 1) At least one relapse* per 12 month period; or 2) At least two relapses* during the previous 24 month period." All requests (including renewal requests) for glatiramer acetate must be completed using the Dimethyl Fumarate/Glatiramer Acetate/Interferon Beta-1a/Interferon Beta-1b/Peginterferon Beta- 1a/Teriflunomide Special Authorization Request Form (ABC 60001). PALIPERIDONE PALMITATE "For the management of the manifestations of schizophrenia in patients who demonstrate a pattern of significant non-compliance that compromises therapeutic success and who possess clinical evidence of previous successful treatment with risperidone or paliperidone therapy; AND who meet at least one of the following criteria: - Experiences extra-pyramidal symptoms with either an oral or depot first generation antipsychotic agent that precludes the use of a first generation antipsychotic depot product; OR - Is refractory to trials of at least two other antipsychotic therapies (Note: one trial must include a first generation antipsychotic agent) To be considered for coverage of Invega Trinza, patients must have been maintained on Invega Sustenna for at least four months. The last two doses of Invega Sustenna should be the same dosage strength and dosing interval, before initiating Invega Trinza. Special Authorization may be granted for six months." All requests (including renewal requests) for paliperidone prolonged release injection must be completed using the Aripiprazole/Paliperidone/Risperidone Prolonged Release Injection Special Authorization Request Form (ABC 60024). The following product(s) are eligible for auto-renewal. 175 MG / SYR (BASE) INJECTION SYRINGE INVEGA TRINZA (0.875 ML SYR) 263 MG / SYR (BASE) INJECTION SYRINGE INVEGA TRINZA (1.315 ML SYR) 350 MG / SYR (BASE) INJECTION SYRINGE INVEGA TRINZA (1.75 ML SYR) 525 MG / SYR (BASE) INJECTION SYRINGE INVEGA TRINZA (2.625 ML SYR) JAI JAI JAI JAI The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 3. 3 EFFECTIVE JULY 1, 2018

16 ALBERTA DRUG BENEFIT LIST UPDATE 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 TABLET APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MAR-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT PMS-RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT TEVA-RIZATRIPTAN ODT MAXALT RPD 10 MG (BASE) ORAL DISINTEGRATING TABLET APO-RIZATRIPTAN RPD JAMP-RIZATRIPTAN ODT MAR-RIZATRIPTAN ODT MYLAN-RIZATRIPTAN ODT NAT-RIZATRIPTAN ODT PMS-RIZATRIPTAN RDT RIZATRIPTAN ODT RIZATRIPTAN ODT SANDOZ RIZATRIPTAN ODT TEVA-RIZATRIPTAN ODT VAN-RIZATRIPTAN ODT MAXALT RPD MAR MYP NTP PMS SNS SIV SDZ TEV MFC MAR MYP NTP PMS SNS SIV SDZ TEV VAN MFC The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. PRODUCT IS NOT INTERCHANGEABLE 3. 4 EFFECTIVE JULY 1, 2018

17 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS VARENICLINE TARTRATE For subsequent prescriptions, patients may obtain this product via special authorization with the following criteria for coverage: "For use in patients 18 years of age and older for smoking cessation treatment in conjunction with smoking cessation counseling. Special authorization coverage may be granted for a maximum of 24 weeks of therapy per year." This product is not eligible for auto-renewal. 0.5 MG (BASE) ORAL TABLET APO-VARENICLINE CHAMPIX 1 MG (BASE) ORAL TABLET APO-VARENICLINE CHAMPIX PFI PFI The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment. UNIT OF ISSUE - REFER TO PRICE POLICY 3. 5 EFFECTIVE JULY 1, 2018

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

Updates to the Alberta Drug Benefit List Effective August 1, 2018 Inquiries should be directed to: Pharmacy Services Alberta Blue Cross 10009 108 Street NW Edmonton AB T5J 3C5 Telephone Number: (780) 498-8370