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

Transcription

1 Updates to the Alberta Drug Benefit List Effective December 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) Website: 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 (R2018/12)

3 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Table of Contents Special Authorization... 1 New Product(s) Available by 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... 2 Added Product(s)... 2 New Established Interchangeable (IC) Grouping(s)... 3 Least Cost Alternative (LCA) Price Change(s)... 4 Product(s) with a Price Change... 4 Discontinued Listing(s)... 5 Part 2 Drug Additions Part 3 Special Authorization EFFECTIVE DECEMBER 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 Trade Name / Strength / Form Generic Description DIN MFR BRIVLERA 10 MG TABLET BRIVARACETAM UCB BRIVLERA 25 MG TABLET BRIVARACETAM UCB BRIVLERA 50 MG TABLET BRIVARACETAM UCB BRIVLERA 75 MG TABLET BRIVARACETAM UCB BRIVLERA 100 MG TABLET BRIVARACETAM UCB HEMANGIOL 3.75 MG / ML ORAL SOLUTION PROPRANOLOL HCL PIE LANCORA 5 MG TABLET IVABRADINE HYDROCHLORIDE SEV LANCORA 7.5 MG TABLET IVABRADINE HYDROCHLORIDE SEV QUINSAIR 100 MG / ML INHALATION SOLUTION LEVOFLOXACIN RAP SPINRAZA 2.4 MG / ML INJECTION NUSINERSEN SODIUM BIO Additional Brand(s) and/or Strength(s) of Drug Product(s) Available by Special Authorization Trade Name / Strength / Form Generic Description DIN MFR O-LACOSAMIDE 50 MG TABLET LACOSAMIDE O-LACOSAMIDE 100 MG TABLET LACOSAMIDE O-LACOSAMIDE 150 MG TABLET LACOSAMIDE O-LACOSAMIDE 200 MG TABLET LACOSAMIDE PHARMA-LACOSAMIDE 50 MG TABLET LACOSAMIDE PHARMA-LACOSAMIDE 100 MG TABLET LACOSAMIDE PHARMA-LACOSAMIDE 150 MG TABLET LACOSAMIDE PHARMA-LACOSAMIDE 200 MG TABLET LACOSAMIDE SANDOZ LACOSAMIDE 50 MG TABLET LACOSAMIDE SANDOZ LACOSAMIDE 100 MG TABLET LACOSAMIDE SANDOZ LACOSAMIDE 150 MG TABLET LACOSAMIDE SANDOZ LACOSAMIDE 200 MG TABLET LACOSAMIDE A-LACOSAMIDE 50 MG TABLET LACOSAMIDE A-LACOSAMIDE 100 MG TABLET LACOSAMIDE A-LACOSAMIDE 150 MG TABLET LACOSAMIDE A-LACOSAMIDE 200 MG TABLET LACOSAMIDE EFFECTIVE DECEMBER 1,

5 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Drug Product(s) with Changes to Criteria for Coverage Trade Name / Strength / Form Generic Description DIN MFR CAYSTON 75 MG / VIAL INHALATION POWDER FOR SOLUTION AZTREONAM GIL Added Product(s) Trade Name / Strength / Form Generic Description DIN MFR ACTIKERALL 0.5 % / 10 % TOPICAL SOLUTION 5-FLUOROURACIL/ SALICYLIC ACID CIP APO-HYDROMORPHONE CR 3 MG CONTROLLED-RELEASE CAPSULE APO-HYDROMORPHONE CR 4.5 MG CONTROLLED-RELEASE CAPSULE APO-HYDROMORPHONE CR 6 MG CONTROLLED-RELEASE CAPSULE APO-HYDROMORPHONE CR 9 MG CONTROLLED-RELEASE CAPSULE APO-HYDROMORPHONE CR 18 MG CONTROLLED-RELEASE CAPSULE APO-HYDROMORPHONE CR 24 MG CONTROLLED-RELEASE CAPSULE APO-HYDROMORPHONE CR 30 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL APX HYDROMORPHONE HCL APX HYDROMORPHONE HCL APX HYDROMORPHONE HCL APX HYDROMORPHONE HCL APX HYDROMORPHONE HCL APX HYDROMORPHONE HCL APX O-DUTASTERIDE 0.5 MG CAPSULE DUTASTERIDE O-TRANDOLAPRIL 0.5 MG CAPSULE TRANDOLAPRIL O-TRANDOLAPRIL 1 MG CAPSULE TRANDOLAPRIL O-TRANDOLAPRIL 2 MG CAPSULE TRANDOLAPRIL O-TRANDOLAPRIL 4 MG CAPSULE TRANDOLAPRIL BACLOFEN 0.05 MG / ML INJECTION BACLOFEN TGT BACLOFEN 0.5 MG / ML INJECTION BACLOFEN TGT BACLOFEN 2 MG / ML INJECTION BACLOFEN TGT DYSPORT THERAPEUTIC 300 IU / VIAL INJECTION ABOBOTULINUMTOXINA ISP DYSPORT THERAPEUTIC 500 IU / VIAL INJECTION ABOBOTULINUMTOXINA ISP ENSTILAR 50 MCG / G / 0.5 MG / G TOPICAL FOAM CALCIPOTRIOL MONOHYDRATE/ BETAMETHASONE DIPROPIONATE LEO JAMP-PREGABALIN 25 MG CAPSULE PREGABALIN JPC JAMP-PREGABALIN 50 MG CAPSULE PREGABALIN JPC JAMP-PREGABALIN 75 MG CAPSULE PREGABALIN JPC JAMP-PREGABALIN 150 MG CAPSULE PREGABALIN JPC 2 EFFECTIVE DECEMBER 1, 2018

6 Added Product(s), continued UPDATES TO THE ALBERTA DRUG BENEFIT LIST Trade Name / Strength / Form Generic Description DIN MFR JAMP-URSODIOL 250 MG TABLET URSODIOL JPC JAMP-URSODIOL 500 MG TABLET URSODIOL JPC MAR-METHIMAZOLE 5 MG TABLET THIAMAZOLE MAR MINT-CANDESARTAN 8 MG TABLET CANDESARTAN CILEXETIL MPI MINT-CANDESARTAN 16 MG TABLET CANDESARTAN CILEXETIL MPI MINT-FUROSEMIDE 20 MG TABLET FUROSEMIDE MPI MINT-FUROSEMIDE 40 MG TABLET FUROSEMIDE MPI ONDANSETRON USP 2 MG / ML INJECTION ONDANSETRON HCL DIHYDRATE STM A-TRANDOLAPRIL 0.5 MG CAPSULE TRANDOLAPRIL A-TRANDOLAPRIL 1 MG CAPSULE TRANDOLAPRIL A-TRANDOLAPRIL 2 MG CAPSULE TRANDOLAPRIL A-TRANDOLAPRIL 4 MG CAPSULE TRANDOLAPRIL TRESIBA FLEXTOUCH PEN 100 UNIT / ML INJECTION INSULIN DEGLUDEC NNA TRESIBA FLEXTOUCH PEN 200 UNIT / ML INJECTION INSULIN DEGLUDEC NNA New Established Interchangeable (IC) Grouping(s) The following IC Grouping(s) have been established and LCA pricing will be applied effective January 1, Generic Description Strength / Form New LCA Price HYDROMORPHONE HCL 3 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL 4.5 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL 6 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL 9 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL 18 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL 24 MG CONTROLLED-RELEASE CAPSULE HYDROMORPHONE HCL 30 MG CONTROLLED-RELEASE CAPSULE LACOSAMIDE 50 MG TABLET LACOSAMIDE 100 MG TABLET LACOSAMIDE 150 MG TABLET LACOSAMIDE 200 MG TABLET THIAMAZOLE 5 MG TABLET EFFECTIVE DECEMBER 1,

7 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 Decrease, will be effective January 1, Please review the online Alberta Drug Benefit List at for further information. Generic Description Strength / Form New LCA Price BACLOFEN 0.05 MG / ML INJECTION BACLOFEN 0.5 MG / ML INJECTION BACLOFEN 2 MG / ML INJECTION FUROSEMIDE 20 MG TABLET FUROSEMIDE 40 MG TABLET TRANDOLAPRIL 0.5 MG CAPSULE TRANDOLAPRIL 1 MG CAPSULE TRANDOLAPRIL 2 MG CAPSULE TRANDOLAPRIL 4 MG CAPSULE URSODIOL 250 MG TABLET URSODIOL 500 MG TABLET Product(s) with a Price Change The following product(s) had a Price Decrease. The previous higher price will be recognized until December 31, For products within an established IC Grouping, the LCA price may apply. Trade Name / Strength / Form Generic Description DIN MFR APO-FUROSEMIDE 20 MG TABLET FUROSEMIDE APX APO-FUROSEMIDE 40 MG TABLET FUROSEMIDE APX BACLOFEN INTRATHECAL 0.05 MG / ML INJECTION BACLOFEN STM BACLOFEN INTRATHECAL 0.5 MG / ML INJECTION BACLOFEN STM BACLOFEN INTRATHECAL 2 MG / ML INJECTION BACLOFEN STM FUROSEMIDE 20 MG TABLET FUROSEMIDE SNS FUROSEMIDE 40 MG TABLET FUROSEMIDE SNS -TRANDOLAPRIL 0.5 MG CAPSULE TRANDOLAPRIL TRANDOLAPRIL 1 MG CAPSULE TRANDOLAPRIL TRANDOLAPRIL 2 MG CAPSULE TRANDOLAPRIL TRANDOLAPRIL 4 MG CAPSULE TRANDOLAPRIL URSODIOL C 250 MG TABLET URSODIOL URSODIOL C 500 MG TABLET URSODIOL SANDOZ TRANDOLAPRIL 0.5 MG CAPSULE TRANDOLAPRIL EFFECTIVE DECEMBER 1, 2018

8 UPDATES TO THE ALBERTA DRUG BENEFIT LIST Product(s) with a Price Change, continued Trade Name / Strength / Form Generic Description DIN MFR SANDOZ TRANDOLAPRIL 1 MG CAPSULE TRANDOLAPRIL SANDOZ TRANDOLAPRIL 2 MG CAPSULE TRANDOLAPRIL SANDOZ TRANDOLAPRIL 4 MG CAPSULE TRANDOLAPRIL A-FUROSEMIDE 20 MG TABLET FUROSEMIDE A-FUROSEMIDE 40 MG TABLET FUROSEMIDE URSODIOL TABLETS USP 250 MG TABLET URSODIOL GLM URSODIOL TABLETS USP 500 MG TABLET URSODIOL GLM 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 December 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 January 1, 2019 claims will no longer pay for these product(s). Trade Name / Strength / Form Generic Description DIN MFR APO-CYCLOSPORINE 100 MG / ML ORAL SOLUTION CYCLOSPORINE APX APO-LACTULOSE 667 MG / ML ORAL SYRUP LACTULOSE APX HOLKIRA PAK 12.5 MG / 75 MG / 50 MG / 250 MG TABLET OMBITASVIR/ PARITAPREVIR/ RITONAVIR/ DASABUVIR SODIUM MONOHYDRATE ABV MYLAN-ALPRAZOLAM 0.25 MG TABLET ALPRAZOLAM MYP PDP-PROCYCLIDINE 0.5 MG / ML ORAL ELIXIR PROCYCLIDINE HCL PPH PDP-PROCYCLIDINE 2.5 MG TABLET PROCYCLIDINE HCL PPH PDP-PROCYCLIDINE 5 MG TABLET PROCYCLIDINE HCL PPH EFFECTIVE DECEMBER 1,

9 Drug Additions PART 2 Drug Additions

10 ALBERTA DRUG BENEFIT LIST UPDATE 5-FLUOROURACIL/ SALICYLIC ACID 0.5 % * 10 % TOPICAL SOLUTION ACTIKERALL CIP ABOBOTULINUMTOXINA 300 IU / VIAL INJECTION DYSPORT THERAPEUTIC 500 IU / VIAL INJECTION DYSPORT THERAPEUTIC ISP ISP BACLOFEN 0.05 MG / ML INJECTION BACLOFEN INJECTION BACLOFEN INTRATHECAL LIORESAL INTRATHECAL 0.5 MG / ML INJECTION BACLOFEN INJECTION BACLOFEN INTRATHECAL LIORESAL INTRATHECAL 2 MG / ML INJECTION BACLOFEN INJECTION BACLOFEN INTRATHECAL LIORESAL INTRATHECAL TGT STM NOV TGT STM NOV TGT STM NOV CANDESARTAN CILEXETIL 8 MG ORAL TABLET APO-CANDESARTAN O-CANDESARTAN CANDESARTAN CANDESARTAN CANDESARTAN CILEXETIL JAMP-CANDESARTAN MINT-CANDESARTAN CANDESARTAN RAN-CANDESARTAN SANDOZ CANDESARTAN A-CANDESARTAN ATACAND 16 MG ORAL TABLET APO-CANDESARTAN CANDESARTAN CANDESARTAN CANDESARTAN CILEXETIL JAMP-CANDESARTAN MINT-CANDESARTAN -CANDESARTAN RAN-CANDESARTAN SANDOZ CANDESARTAN A-CANDESARTAN ATACAND APX SIV SNS AHI JPC MPI RAN AZC APX SIV SNS AHI JPC MPI RAN AZC 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 DECEMBER 1, 2018

11 ALBERTA DRUG BENEFIT LIST UPDATE DUTASTERIDE 0.5 MG ORAL CAPSULE ACT DUTASTERIDE APO-DUTASTERIDE O-DUTASTERIDE DUTASTERIDE DUTASTERIDE MED-DUTASTERIDE MINT-DUTASTERIDE DUTASTERIDE SANDOZ DUTASTERIDE A-DUTASTERIDE AVODART APH APX SIV SNS GMP MPI GSK FUROSEMIDE 20 MG ORAL TABLET APO-FUROSEMIDE FUROSEMIDE MINT-FUROSEMIDE A-FUROSEMIDE 40 MG ORAL TABLET APO-FUROSEMIDE FUROSEMIDE MINT-FUROSEMIDE A-FUROSEMIDE APX SNS MPI APX SNS MPI INSULIN DEGLUDEC 100 U/ML / ML INJECTION TRESIBA FLEXTOUCH PEN 200 U/ML / ML INJECTION TRESIBA FLEXTOUCH PEN NNA NNA ONDANSETRON HCL DIHYDRATE 2 MG / ML (BASE) INJECTION JAMP-ONDANSETRON (PRESERVATIVE FREE) ONDANSETRON (PRESERVATIVE FREE) ONDANSETRON (UNPRESERVED) ONDANSETRON INJECTION USP ZOFRAN JPC MYP STM NOV 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 DECEMBER 1, 2018

12 ALBERTA DRUG BENEFIT LIST UPDATE PREGABALIN 25 MG ORAL CAPSULE APO-PREGABALIN O-PREGABALIN JAMP-PREGABALIN MINT-PREGABALIN PREGABALIN PREGABALIN PREGABALIN RAN-PREGABALIN SANDOZ PREGABALIN A-PREGABALIN 50 MG ORAL CAPSULE APO-PREGABALIN O-PREGABALIN JAMP-PREGABALIN MINT-PREGABALIN PREGABALIN PREGABALIN PREGABALIN RAN-PREGABALIN SANDOZ PREGABALIN A-PREGABALIN 75 MG ORAL CAPSULE APO-PREGABALIN O-PREGABALIN JAMP-PREGABALIN MINT-PREGABALIN PREGABALIN PREGABALIN PREGABALIN RAN-PREGABALIN SANDOZ PREGABALIN A-PREGABALIN 150 MG ORAL CAPSULE APO-PREGABALIN O-PREGABALIN JAMP-PREGABALIN MINT-PREGABALIN -PREGABALIN PREGABALIN PREGABALIN RAN-PREGABALIN SANDOZ PREGABALIN A-PREGABALIN APX JPC MPI SIV SNS RAN APX JPC MPI SIV SNS RAN APX JPC MPI SIV SNS RAN APX JPC MPI SIV SNS RAN THIAMAZOLE 5 MG ORAL TABLET MAR-METHIMAZOLE TAPAZOLE MAR PAL 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 DECEMBER 1, 2018

13 ALBERTA DRUG BENEFIT LIST UPDATE TRANDOLAPRIL 0.5 MG ORAL CAPSULE O-TRANDOLAPRIL TRANDOLAPRIL SANDOZ TRANDOLAPRIL A-TRANDOLAPRIL MAVIK 1 MG ORAL CAPSULE O-TRANDOLAPRIL TRANDOLAPRIL SANDOZ TRANDOLAPRIL A-TRANDOLAPRIL MAVIK 2 MG ORAL CAPSULE O-TRANDOLAPRIL TRANDOLAPRIL SANDOZ TRANDOLAPRIL A-TRANDOLAPRIL MAVIK 4 MG ORAL CAPSULE O-TRANDOLAPRIL -TRANDOLAPRIL SANDOZ TRANDOLAPRIL A-TRANDOLAPRIL MAVIK BGP BGP BGP BGP URSODIOL 250 MG ORAL TABLET JAMP-URSODIOL URSODIOL C URSODIOL TABLETS USP URSO 500 MG ORAL TABLET JAMP-URSODIOL -URSODIOL C URSODIOL TABLETS USP URSO DS JPC GLM AXC JPC GLM AXC 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. 4 EFFECTIVE DECEMBER 1, 2018

14 Special Authorization PART 3 Special Authorization

15 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS AZTREONAM The drug product(s) listed below are eligible for coverage via the step therapy/special authorization process. FIRST-LINE DRUG PRODUCT(S): TOBRAMYCIN INHALATION SOLUTION "For the treatment of chronic pulmonary Pseudomonas aeruginosa infections when used as cyclic treatment (28-day cycles) in patients 6 years of age and older with moderate to severe cystic fibrosis (CF) and deteriorating clinical condition despite treatment with inhaled tobramycin. Coverage will not be considered when inhaled aztreonam and other inhaled antibiotic(s) (e.g. levofloxacin, tobramycin) are intended for use in combination. Special authorization may be granted for 6 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 75 MG / VIAL INHALATION POWDER FOR SOLUTION CAYSTON GIL BRIVARACETAM "For adjunctive therapy in patients with refractory partial-onset seizures who meet all of the following criteria: - Are currently receiving two or more antiepileptic medications, AND - Have failed or demonstrated intolerance to three other antiepileptic medications, AND - Patients are not receiving concurrent therapy with levetiracetam, AND, - Therapy must be initiated by a Neurologist. For the purpose of administering these criteria failure is defined as inability to achieve satisfactory seizure control. Special authorization may be granted for six months. Coverage cannot be provided for brivaracetam, eslicarbazepine, lacosamide or perampanel when these medications are intended for use in combination." Each of these products is eligible for auto-renewal. 10 MG ORAL TABLET BRIVLERA 25 MG ORAL TABLET BRIVLERA 50 MG ORAL TABLET BRIVLERA 75 MG ORAL TABLET BRIVLERA 100 MG ORAL TABLET BRIVLERA UCB UCB UCB UCB UCB 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 DECEMBER 1, 2018

16 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS IVABRADINE HYDROCHLORIDE "For the treatment of heart failure (HF) in patients with the following criteria: 1) Reduced left ventricular ejection fraction (LVEF) (less than or equal to 35%) And 2) New York Heart Association (NYHA) class II or III HF symptoms despite at least FOUR weeks of optimal treatment with: - a stable dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB) - in combination with a beta-blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA) And 3) Who are in sinus rhythm with a resting heart rate greater than or equal to 77 beats per minute (bpm) on average using either an ECG on at least three separate visits or by continuous monitoring And 4) Who had at least one hospitalization due to HF in the last year For coverage, this drug must be initiated by a Specialist in Cardiology or Internal Medicine, and the initial request must be completed by the Specialist. Special authorization may be granted for six months." This product is eligible for auto-renewal. All requests (including renewal requests) for ivabradine hydrochloride must be completed using the Eplerenone/Ivabradine/Sacubitril+Valsartan Special Authorization Request Form (ABC 60050). 5 MG (BASE) ORAL TABLET LANCORA 7.5 MG (BASE) ORAL TABLET LANCORA SEV SEV 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 DECEMBER 1, 2018

17 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS LACOSAMIDE "For adjunctive therapy in patients with refractory partial-onset seizures who meet all of the following criteria: - Are currently receiving two or more antiepileptic medications, AND - Have failed or demonstrated intolerance to three other antiepileptic medications, AND - Therapy must be initiated by a Neurologist. For the purpose of administering these criteria failure is defined as inability to achieve satisfactory seizure control. Special authorization may be granted for six months. Coverage cannot be provided for eslicarbazepine, lacosamide or perampanel when these medications are intended for use in combination." Each of these products is eligible for auto-renewal. 50 MG ORAL TABLET O-LACOSAMIDE PHARMA-LACOSAMIDE SANDOZ LACOSAMIDE A-LACOSAMIDE VIMPAT 100 MG ORAL TABLET O-LACOSAMIDE PHARMA-LACOSAMIDE SANDOZ LACOSAMIDE A-LACOSAMIDE VIMPAT 150 MG ORAL TABLET O-LACOSAMIDE PHARMA-LACOSAMIDE SANDOZ LACOSAMIDE A-LACOSAMIDE VIMPAT 200 MG ORAL TABLET O-LACOSAMIDE PHARMA-LACOSAMIDE SANDOZ LACOSAMIDE A-LACOSAMIDE VIMPAT UCB UCB UCB UCB 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 DECEMBER 1, 2018

18 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS LEVOFLOXACIN The drug product(s) listed below are eligible for coverage via the step therapy/special authorization process. FIRST-LINE DRUG PRODUCT(S): TOBRAMYCIN INHALATION SOLUTION "For the treatment of chronic pulmonary Pseudomonas aeruginosa infections when used as cyclic treatment (28-day cycles) in patients 18 years of age and older with moderate to severe cystic fibrosis (CF) and deteriorating clinical condition despite treatment with inhaled tobramycin." "Coverage will not be considered when inhaled levofloxacin and other inhaled antibiotic(s) (e.g. tobramycin, aztreonam) are intended for use in combination, either concurrently or for antibiotic cycling during off-treatment periods." "Special authorization may be granted for 6 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 100 MG / ML INHALATION SOLUTION QUINSAIR RAP 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 DECEMBER 1, 2018

19 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS NUSINERSEN SODIUM "For patients diagnosed with 5q Spinal Muscular Atrophy (SMA) Type 1 under the care of a specialist with experience in the diagnosis and management of SMA, if the following clinical criteria are met: - Genetic documentation of 5q SMA homozygous gene deletion, homozygous mutation, or compound heterozygote, AND - Genetic documentation of two copies of the survival motor neuron 2 (SMN2) gene, AND - Disease duration less than 26 weeks with onset of clinical signs and symptoms consistent with SMA after the first week after birth and on or before 7 months of age, AND - Patient is not currently requiring permanent invasive ventilation.* Initial coverage may be approved for three 12 mg doses at Day 0, Day 14 and Day 28, followed by one 12 mg dose at Day 63. Patients will be limited to receiving one dose of nusinersen per prescription at their pharmacy. For continued coverage, the patient must meet the following criteria: - there is demonstrated maintenance of motor milestone function (as assessed using the Hammersmith Infant Neurological Examination [HINE] Section 2) compared to pre-treatment baseline; OR - there is demonstrated improvement in motor milestone function (as assessed using the HINE Section 2) compared to pre-treatment baseline; AND - patient does not require permanent invasive ventilation*. Continued coverage may be considered for one 12 mg maintenance dose at a time, to be administered at 4-month intervals. Each maintenance dose cannot be considered prior to 4 months elapsing from the date of the previous dose. Treatment should be discontinued if, prior to the fifth dose or every subsequent dose of nusinersen, the above renewal criteria are not met. *Permanent invasive ventilation is defined as the use of tracheostomy and a ventilator due to progression of SMA that is not due to an identifiable and reversible cause. All requests (including renewal requests) for nusinersen must be completed using the Nusinersen Special Authorization Request Form (ABC 60064)." 2.4 MG / ML (BASE) INJECTION SPINRAZA BIO 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 DECEMBER 1, 2018

20 ALBERTA DRUG BENEFIT LIST UPDATE CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS PROPRANOLOL HCL "For the treatment of proliferating infantile hemangioma requiring systemic therapy and at least one of the following: - Life- or function-threatening hemangioma, OR - Ulcerated hemangioma with pain and/or lack of response to simple wound care measures, OR - Hemangioma with a risk of permanent scarring or disfigurement. Special authorization may be granted for 12 months. Continued coverage may be approved for a period of 12 months for patients who are responding to therapy or experience relapse of symptoms after treatment discontinuation." 3.75 MG / ML ORAL SOLUTION HEMANGIOL PIE 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. 6 EFFECTIVE DECEMBER 1, 2018