Updates to the Alberta Drug Benefit List. Effective July 1, 2017

Transcription

1 Updates to the Alberta Drug Benefit List Effective July 1, 2017

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) Website: Administered by Alberta Blue Cross on behalf of Alberta Health. The Drug Benefit List (DBL) is a list of drugs for which coverage June 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 June 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 (R2017/07)

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 Products Available by Step Therapy / Special Authorization... 1 Added Product(s)... 1 Restricted Benefit(s)... 2 Additional Brand(s) and/or Strength(s) of Drug Products Available by Restricted Benefit... 2 New Established Interchangeable (IC) Grouping(s)... 2 Least Cost Alternative (LCA) Price Change(s)... 3 Product(s) with a Price Change... 3 Discontinued Listing(s)... 3 Product(s) Removed from the ADBL as Price Policy Requirements Not Satisfied... 4 Part 2 Drug Additions Part 3 Special Authorization EFFECTIVE JULY 1, 2017

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 July 1, 2017 Updates to the Alberta Human Services Drug Benefit Supplement. New Drug Product(s) Available by Special Authorization Trade Name / Strength / Form Generic Description DIN MFR ENTYVIO 300 MG / VIAL INJECTION VEDOLIZUMAB TAK FERRIPROX 1000 MG TABLET DEFERIPRONE APP FERRIPROX 100 MG / ML ORAL SOLUTION DEFERIPRONE APP PLEGRIDY 125 MCG / SYRINGE INJECTION SYRINGE PEGINTERFERON BETA-1A BIO PLEGRIDY 63 MCG / SYRINGE / 94 MCG / SYRINGE INJECTION SYRINGE PEGINTERFERON BETA-1A/ PEGINTERFERON BETA-1A BIO Additional Brand(s) and/or Strength(s) of Drug Products Available by Step Therapy / Special Authorization Trade Name / Strength / Form Generic Description DIN MFR APO-CABERGOLINE 0.5 MG TABLET CABERGOLINE Added Product(s) Trade Name / Strength / Form Generic Description DIN MFR ACT OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL APH ACT OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL APH ACT OLMESARTAN HCT 20 MG / 12.5 MG TABLET ACT OLMESARTAN HCT 40 MG / 12.5 MG TABLET ACT OLMESARTAN HCT 40 MG / 25 MG TABLET OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE APH APH APH APO-OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL APO-OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL APO-OLMESARTAN / HCTZ 20 MG / 12.5 MG TABLET APO-OLMESARTAN / HCTZ 40 MG / 12.5 MG TABLET APO-OLMESARTAN / HCTZ 40 MG / 25 MG TABLET OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE AURO-OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL AUR EFFECTIVE JULY 1,

5 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Added Product(s), continued Trade Name / Strength / Form Generic Description DIN MFR AURO-OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL AUR FOSINOPRIL 10 MG TABLET FOSINOPRIL SODIUM SNS FOSINOPRIL 20 MG TABLET FOSINOPRIL SODIUM SNS JAMP-OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL JPC JAMP-OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL JPC LIDODAN 2% TOPICAL JELLY LIDOCAINE HCL ODN MYLAN-DIVALPROEX 125 MG ENTERIC-COATED TABLET MYLAN-DIVALPROEX 250 MG ENTERIC-COATED TABLET MYLAN-DIVALPROEX 500 MG ENTERIC-COATED TABLET DIVALPROEX SODIUM (VALPROIC ACID EQUIVALENT) DIVALPROEX SODIUM (VALPROIC ACID EQUIVALENT) DIVALPROEX SODIUM (VALPROIC ACID EQUIVALENT) MYP MYP MYP MYLAN-DULOXETINE 30 MG DELAYED-RELEASE CAPSULE MYLAN-DULOXETINE 60 MG DELAYED-RELEASE CAPSULE DULOXETINE HYDROCHLORIDE MYP DULOXETINE HYDROCHLORIDE MYP SANDOZ OLMESARTAN 20 MG TABLET OLMESARTAN MEDOXOMIL SDZ SANDOZ OLMESARTAN 40 MG TABLET OLMESARTAN MEDOXOMIL SDZ Restricted Benefit(s) Additional Brand(s) and/or Strength(s) of Drug Products Available by Restricted Benefit Trade Name / Strength / Form Generic Description DIN MFR AEROCHAMBER PLUS FLOW-VU W/ ADULT SMALL MASK ADULT DEVICE AEROSOL HOLDING CHAMBER/ MASK TMI 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 OLMESARTAN MEDOXOMIL 20 MG TABLET OLMESARTAN MEDOXOMIL 40 MG TABLET OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE 20 MG / 12.5 MG TABLET MG / 12.5 MG TABLET MG / 25 MG TABLET EFFECTIVE JULY 1, 2017

6 UPDATES TO THE ALBERTA DRUG BENEFIT LIST 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 change, will be effective August 1, Please review the online Alberta Drug Benefit List at for further information. Generic Description Strength / Form New LCA Price AMCINONIDE 0.1 % TOPICAL LOTION AMCINONIDE 0.1 % TOPICAL OINTMENT CABERGOLINE 0.5 MG TABLET SALBUTAMOL SULFATE 2 MG / ML INHALATION UNIT DOSE SOLUTION 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. Trade Name / Strength / Form Generic Description DIN MFR CLINDOXYL ADV 1% / 3% TOPICAL GEL CLINDAMYCIN PHOSPHATE/ BENZOYL PEROXIDE GSK CYCLOCORT 0.1% TOPICAL CREAM AMCINONIDE GSK CYCLOCORT 0.1% TOPICAL LOTION AMCINONIDE GSK CYCLOCORT 0.1% TOPICAL OINTMENT AMCINONIDE GSK PREVEX B 0.1% TOPICAL OCCLUSIVE CREAM BETAMETHASONE VALERATE GSK STIEVA-A 0.05% TOPICAL CREAM TRETINOIN GSK VENTOLIN 5 MG / ML INHALATION SOLUTION SALBUTAMOL SULFATE GSK VENTOLIN NEBULES P.F. 1 MG / ML INHALATION SOLUTION VENTOLIN NEBULES P.F. 2 MG / ML INHALATION UNIT DOSE SOLUTION SALBUTAMOL SULFATE GSK SALBUTAMOL SULFATE GSK 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, 2017, 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, 2017 claims will no longer pay for these product(s). Trade Name / Strength / Form Generic Description DIN MFR ACT AZITHROMYCIN 250 MG TABLET AZITHROMYCIN APH CO FENTANYL 12 MCG / HR TRANSDERMAL PATCH FENTANYL APH EFFECTIVE JULY 1,

7 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Discontinued Listing(s), continued Trade Name / Strength / Form Generic Description DIN MFR CO FENTANYL 25 MCG / HR TRANSDERMAL PATCH CO FENTANYL 50 MCG / HR TRANSDERMAL PATCH CO FENTANYL 75 MCG / HR TRANSDERMAL PATCH CO FENTANYL 100 MCG / HR TRANSDERMAL PATCH FENTANYL APH FENTANYL APH FENTANYL APH FENTANYL APH EMO-CORT 2.5% TOPICAL LOTION HYDROCORTISONE GSK MYLAN-VALSARTAN HCTZ 160 MG / 12.5 MG TABLET MYLAN-VALSARTAN HCTZ 160 MG / 25 MG TABLET VALSARTAN/ HYDROCHLOROTHIAZIDE VALSARTAN/ HYDROCHLOROTHIAZIDE MYP MYP NERISONE OILY 0.1% TOPICAL CREAM DIFLUCORTOLONE VALERATE GSK SANDOZ RAMIPRIL 1.25 MG TABLET RAMIPRIL SDZ Product(s) Removed from the ADBL as Price Policy Requirements Not Satisfied The Alberta government-sponsored drug programs previously covered the following drug product(s). Effective July 1, 2017, 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, 2017 claims will no longer pay for these product(s). Trade Name / Strength / Form Generic Description DIN MFR ACT CABERGOLINE 0.5 MG TABLET CABERGOLINE APH 4 EFFECTIVE JULY 1, 2017

8 Drug Additions PART 2 Drug Additions

9 AEROSOL HOLDING CHAMBER/MASK RESTRICTED BENEFIT - Coverage is limited to one of each size (infant, pediatric, adult) aerosol holding chamber mask or chamber w/ mask per plan participant per year. ADULT DEVICE VORTEX ADULT MASK DEVICE KGH OPTICHAMBER ADVANTAGE II (WITH LARGE RNA MASK) OPTICHAMBER DIAMOND (WITH LARGE RNA MASK) AEROCHAMBER PLUS FLOW-VU W/ ADULT TMI SMALL MASK AEROCHAMBER PLUS FLOW-VU W/ LARGE TMI MASK AMCINONIDE 0.1 % TOPICAL CREAM RATIO-AMCINONIDE TARO-AMCINONIDE CYCLOCORT 0.1 % TOPICAL OINTMENT CYCLOCORT RATIO-AMCINONIDE 0.1 % TOPICAL LOTION CYCLOCORT RATIO-AMCINONIDE TAR GSK GSK GSK BETAMETHASONE VALERATE 0.1 % (BASE) TOPICAL OCCLUSIVE CREAM PREVEX B GSK DIVALPROEX SODIUM (VALPROIC ACID EQUIV.) 125 MG (BASE) ORAL ENTERIC-COATED TABLET APO-DIVALPROEX MYLAN-DIVALPROEX NOVO-DIVALPROEX EPIVAL 250 MG (BASE) ORAL ENTERIC-COATED TABLET APO-DIVALPROEX MYLAN-DIVALPROEX NOVO-DIVALPROEX EPIVAL 500 MG (BASE) ORAL ENTERIC-COATED TABLET APO-DIVALPROEX MYLAN-DIVALPROEX NOVO-DIVALPROEX EPIVAL MYP BGP MYP BGP MYP BGP UNIT OF ISSUE - REFER TO PRICE POLICY 2. 1 EFFECTIVE JULY 1, 2017

10 DULOXETINE HYDROCHLORIDE 30 MG (BASE) ORAL DELAYED-RELEASE CAPSULE APO-DULOXETINE AURO-DULOXETINE DULOXETINE DULOXETINE DR JAMP-DULOXETINE MAR-DULOXETINE MINT-DULOXETINE MYLAN-DULOXETINE PMS-DULOXETINE RAN-DULOXETINE SANDOZ DULOXETINE CYMBALTA 60 MG (BASE) ORAL DELAYED-RELEASE CAPSULE APO-DULOXETINE AURO-DULOXETINE DULOXETINE DULOXETINE DR JAMP-DULOXETINE MAR-DULOXETINE MINT-DULOXETINE MYLAN-DULOXETINE PMS-DULOXETINE RAN-DULOXETINE SANDOZ DULOXETINE CYMBALTA AUR SIV JPC MAR MPI MYP PMS RAN SDZ LIL AUR SIV JPC MAR MPI MYP PMS RAN SDZ LIL FOSINOPRIL SODIUM 10 MG ORAL TABLET APO-FOSINOPRIL FOSINOPRIL JAMP-FOSINOPRIL MYLAN-FOSINOPRIL A-FOSINOPRIL 20 MG ORAL TABLET APO-FOSINOPRIL FOSINOPRIL JAMP-FOSINOPRIL MYLAN-FOSINOPRIL A-FOSINOPRIL SNS JPC MYP SNS JPC MYP LIDOCAINE HCL 2 % TOPICAL JELLY LIDODAN XYLOCAINE JELLY ODN AZC PRODUCT IS NOT INTERCHANGEABLE 2. 2 EFFECTIVE JULY 1, 2017

11 OLMESARTAN MEDOXOMIL 20 MG ORAL TABLET ACT OLMESARTAN APO-OLMESARTAN AURO-OLMESARTAN JAMP-OLMESARTAN SANDOZ OLMESARTAN OLMETEC 40 MG ORAL TABLET ACT OLMESARTAN APO-OLMESARTAN AURO-OLMESARTAN JAMP-OLMESARTAN SANDOZ OLMESARTAN OLMETEC APH AUR JPC SDZ MFC APH AUR JPC SDZ MFC OLMESARTAN MEDOXOMIL/ HYDROCHLOROTHIAZIDE 20 MG * 12.5 MG ORAL TABLET ACT OLMESARTAN HCT APO-OLMESARTAN/HCTZ OLMETEC PLUS 40 MG * 12.5 MG ORAL TABLET ACT OLMESARTAN HCT APO-OLMESARTAN/HCTZ OLMETEC PLUS 40 MG * 25 MG ORAL TABLET ACT OLMESARTAN HCT APO-OLMESARTAN/HCTZ OLMETEC PLUS APH MFC APH MFC APH MFC SALBUTAMOL SULFATE 1 MG / ML (BASE) INHALATION SOLUTION PMS-SALBUTAMOL A-SALBUTAMOL STERINEBS P.F VENTOLIN NEBULES P.F. 5 MG / ML (BASE) INHALATION SOLUTION VENTOLIN 2 MG / ML (BASE) INHALATION UNIT DOSE SOLUTION VENTOLIN NEBULES P.F. PMS-SALBUTAMOL POLYNEB A-SALBUTAMOL STERINEBS P.F. PMS GSK GSK GSK PMS UNIT OF ISSUE - REFER TO PRICE POLICY 2. 3 EFFECTIVE JULY 1, 2017

12 Special Authorization PART 3 Special Authorization

13 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS CABERGOLINE The drug product(s) listed below are eligible for coverage via the step therapy/special authorization process. FIRST-LINE DRUG PRODUCT(S): BROMOCRIPTINE "For the treatment of hyperprolactinemia in patients who are intolerant to or who have failed bromocriptine. Special authorization may be granted for 24 months." Note: If a claim for the Step therapy drug product is rejected, pharmacists can use their professional judgment to determine the appropriateness of using the intervention code(s) noted below to re-submit a claim. The pharmacist is responsible to document on the patient's record the rationale for using the second-line therapy drug. UP - First-line therapy ineffective UQ - First-line therapy not tolerated 0.5 MG ORAL TABLET APO-CABERGOLINE DOSTINEX PAL CLINDAMYCIN PHOSPHATE/ BENZOYL PEROXIDE "For the treatment of severe acne as defined by scarring acne. Special Authorization may be granted for 6 months." The following product(s) are eligible for auto-renewal. 1 % * 3 % TOPICAL GEL CLINDOXYL ADV GSK DEFERIPRONE "For the treatment of transfusional iron overload due to thalassemia syndromes in patients who require iron chelation therapy but who have an inadequate response to a sufficient trial (i.e. a minimum of 6 months) of deferoxamine, or for whom deferoxamine is contraindicated. Contraindications to deferoxamine may include one or more of the following: known or suspected sensitivity to deferoxamine, recurrent injection or infusion-site reactions associated with deferoxamine administration (e.g., cellulitis), inability to obtain or maintain vascular access, severe needle phobia, concomitant bleeding disorders, immunocompromised patients with a risk of infection with parenteral administration, or risk of bleeding due to anticoagulation. Special authorization may be granted for 6 months." This product is eligible for auto-renewal. All requests (including renewal requests) for deferiprone must be completed using the Deferiprone Special Authorization Request Form (ABC 60054). 1,000 MG ORAL TABLET FERRIPROX 100 MG / ML ORAL SOLUTION FERRIPROX APP APP UNIT OF ISSUE - REFER TO PRICE POLICY 3. 1 EFFECTIVE JULY 1, 2017

14 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS PEGINTERFERON BETA-1A "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 onemonth supply of peg-interferon beta-1a 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 peg-interferon beta-1a per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months 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 peg-interferon beta-1a must be completed using PRODUCT IS NOT INTERCHANGEABLE 3. 2 EFFECTIVE JULY 1, 2017

15 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS PEGINTERFERON BETA-1A the Dimethyl Fumarate/Glatiramer Acetate/Interferon Beta-1a/Interferon Beta-1b/Peginterferon Beta-1a/Teriflunomide Special Authorization Request Form (ABC 60001). 125 MCG / SYR INJECTION SYRINGE PLEGRIDY BIO UNIT OF ISSUE - REFER TO PRICE POLICY 3. 3 EFFECTIVE JULY 1, 2017

16 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS PEGINTERFERON BETA-1A/ PEGINTERFERON BETA-1A "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 onemonth supply of peg-interferon beta-1a 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 peg-interferon beta-1a per prescription at their pharmacy. Restarting After an Interruption in Therapy Greater Than 12 Months 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 PRODUCT IS NOT INTERCHANGEABLE 3. 4 EFFECTIVE JULY 1, 2017

17 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS PEGINTERFERON BETA-1A/ PEGINTERFERON BETA-1A 2) At least two relapses* during the previous 24 month period." All requests (including renewal requests) for peg-interferon beta-1a 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). 63 MCG / SYR * 94 MCG / SYR INJECTION SYRINGE PLEGRIDY BIO TRETINOIN "For the treatment of severe acne as defined by scarring acne. Special authorization may be granted for 6 months." The following product(s) are eligible for auto-renewal % TOPICAL CREAM STIEVA-A GSK UNIT OF ISSUE - REFER TO PRICE POLICY 3. 5 EFFECTIVE JULY 1, 2017

18 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS VEDOLIZUMAB Moderately to Severe Active Crohn's Disease "Special authorization coverage may be approved for coverage of vedolizumab for the reduction in signs and symptoms and induction and maintenance of clinical remission of Moderately to Severely Active Crohn's Disease in patients who meet the following criteria: - vedolizumab must be prescribed by a Specialist in Gastroenterology or a physician appropriately trained by the University of Alberta or the University of Calgary and recognized as a prescriber by Alberta Blue Cross for coverage for the treatment of Moderately to Severely Active Crohn's Disease patients ('Specialist'). - Patients must be 18 years of age or older to be considered for coverage of vedolizumab. - Patients will be limited to receiving one dose of vedolizumab per prescription at their pharmacy. - Patients may be allowed to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy (both primary loss of response and secondary loss of response) 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. - Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed. Prior to initiation of vedolizumab therapy for New Patients: 'New Patients' are patients who have never been treated with vedolizumab by any health care provider. Moderately to Severely Active Crohn's Disease: Prior to initiation of vedolizumab therapy, New Patients must have a current Modified (without the physical exam) Harvey Bradshaw Index score of greater than or equal to 7 (New Patient's Baseline Score), AND be Refractory. Refractory is defined as one or more of the following: 1) Serious adverse effects or reactions to the treatments specified below; OR 2) Contraindications (as defined in product monographs) to the treatments specified below; OR 3) Previous documented lack of effect at doses and for duration of all treatments specified below: a) mesalamine: minimum of 3 grams/day for a minimum of 6 weeks; AND refractory to, or dependent on, glucocorticoids: following at least one tapering dosing schedule of 40 mg/day, tapering by 5 mg each week to 20 mg, then tapering by 2.5 mg each week to zero, or similar. [Note: Patients who have used the above treatments in combination will not be required to be challenged with individual treatments as monotherapy] AND b) Immunosuppressive therapy as follows: - Azathioprine: minimum of 2 mg/kg/day for a minimum of 3 months; OR - 6-mercaptopurine: minimum of 1 mg/kg/day for a minimum of 3 months; OR - Methotrexate: minimum or 15 mg/week for a minimum of 3 months. OR - Immunosuppressive therapy discontinued at less than 3 months due to serious adverse effects or reactions. Applications for coverage must include information regarding the dosages and duration of trial of each treatment the patient received, a description of any adverse effects, reactions, contraindications and/or lack of effect, as well as any other information requested by Alberta Blue Cross. Coverage Criteria for Moderately to Severely Active Crohn's Disease - New Patients must meet the criteria above prior to being considered for approval. - All approvals are also subject to the following applicable criteria. Induction Dosing for New Patients: - Coverage for Induction Dosing may only be approved for New Patients (those who have never PRODUCT IS NOT INTERCHANGEABLE 3. 6 EFFECTIVE JULY 1, 2017

19 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS VEDOLIZUMAB been treated with vedolizumab by any health care provider). - 'Induction Dosing' means a maximum of one 300 mg dose of vedolizumab per New Patient at 0, 2 and 6 weeks (for a maximum total of three doses). - New Patients are eligible to receive Induction Dosing only once, after which time the Maintenance Dosing for New Patients and Continued Coverage for Maintenance Dosing criteria will apply. Maintenance Dosing: 'Maintenance Dosing' means one 300 mg dose of vedolizumab per patient every eight (8) weeks for a period of 12 months to: - New Patients following the completion of Induction Dosing; OR - Existing Patients, who are patients that are being treated, or have previously been treated, with vedolizumab. Maintenance Dosing for New Patients after Completion of Induction Dosing: - The New Patient must be assessed by a Specialist between weeks 10 and 14 after the initiation of Induction Dosing to determine response by obtaining a Modified Harvey Bradshaw Index score for patients with Moderately to Severely Active Crohn's Disease; AND - The Specialist must confirm the Modified Harvey Bradshaw Index score shows a decrease from the New Patient's Baseline Score of greater than or equal to 3 points for patients with Moderately to Severely Active Crohn's. Maintenance Dosing for Existing Patients: - The patient must be assessed by a Specialist at least 4 to 8 weeks after the day the last dose of vedolizumab was administered to the patient and prior to administration of the next dose to obtain: a Modified Harvey Bradshaw Index Score (Existing Patient's Baseline Score) for Moderately to Severely Active Crohn's; AND - these measures must be provided to Alberta Blue Cross for assessment for continued coverage for maintenance dosing. Continued Coverage for Maintenance Dosing: -Continued coverage may be considered for one 300 mg dose of vedolizumab per patient provided no more often than every 8 weeks for a period of 12 months, if the following criteria are met at the end of each 12 month period: - The New Patient or the Existing Patient must be assessed by a Specialist at least 4 to 6 weeks after the day the last dose of vedolizumab was administered to the patient and prior to the administration of the next dose to obtain a Modified Harvey Bradshaw Index Score for Moderately to Severely Active Crohn's; AND - For New Patients: The Specialist must confirm that the patient has maintained a greater than or equal to 3 point decrease from the New Patient's Baseline Score for Moderately to Severely Active Crohn's; OR - For Existing Patients: The Specialist must confirm that the patient has maintained the Existing Patient's Baseline Score." All requests (including renewal requests) for vedolizumab for Moderately to Severely Active Crohn's Disease must be completed using the Adalimumab/Vedolizumab for Crohn's/Infliximab for Crohn's/Fistulizing Crohn's Special Authorization Request Form (ABC 60031). Ulcerative Colitis "Special authorization coverage may be provided for the reduction in signs and symptoms and induction and maintenance of clinical remission of Ulcerative Colitis in adult patients (18 years of age or older) with active disease (characterized by a partial Mayo score >4 prior to initiation of biologic therapy) and who are refractory or intolerant to: - mesalamine: minimum of 4 grams/day for a minimum of 4 weeks AND - corticosteroids (failure to respond to prednisone 40 mg daily for 2 weeks, or; steroid dependent UNIT OF ISSUE - REFER TO PRICE POLICY 3. 7 EFFECTIVE JULY 1, 2017

20 CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS VEDOLIZUMAB i.e. failure to taper off steroids without recurrence of disease or disease requiring a second dose of steroids within 12 months of previous dose). 'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above. 'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs. Immunosuppressive therapy as follows may also be initiated if in the clinician's judgment a trial is warranted: i) Azathioprine: minimum of 2 mg/kg/day for a minimum of 2 months; OR ii) 6-mercaptopurine: minimum of 1 mg/kg/day for a minimum of 2 months For coverage, this drug must be prescribed by a Specialist in Gastroenterology or a physician appropriately trained by the University of Alberta or the University of Calgary and recognized as a prescriber by Alberta Blue Cross ('Specialist'). Initial coverage may be approved for three doses of 300 mg of vedolizumab at 0, 2 and 6 weeks. - Patients will be limited to receiving a one dose of vedolizumab 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. - Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed. For continued coverage beyond three doses, the patient must meet the following criteria: 1) The patient must be assessed by a Specialist between weeks 10 and 12 after the initiation of therapy to determine response. 2) The Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria: - a decrease in the partial Mayo score of greater than or equal to 2 points Following this assessment, continued coverage may be approved for a dose of 300 mg every 8 weeks for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period: 1) The patient has been assessed by a Specialist in Gastroenterology to determine response; 2) The Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by: - a decrease in the partial Mayo score of greater than or equal to 2 points from the score prior to initiation of vedolizumab therapy." All requests (including renewal requests) for vedolizumab for Ulcerative Colitis must be completed using the Golimumab/Infliximab/Vedolizumab for Ulcerative Colitis Special Authorization Request Form (ABC 60008). 300 MG / VIAL INJECTION ENTYVIO TAK PRODUCT IS NOT INTERCHANGEABLE 3. 8 EFFECTIVE JULY 1, 2017