Alberta Drug Benefit List - Alberta Blue Cross

Alberta Drug Benefit List

Effective April 1, 2021

Inquiries should be directed to:

78B

Pharmacy Services Alberta Blue Cross 10009 108 Street NW Edmonton AB T5J 3C5

Telephone Number: (780) 498-8370 (Edmonton) (403) 294-4041 (Calgary) 1-800-361-9632 (Toll Free)

Fax Number:

(780) 498-8384 1-877-828-4106 (Toll Free)

Websit 109B e:

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.

ABC 40211/81160 (R2021/04)

ALBERTA DRUG BENEFIT LIST

1BTable of Contents

PART 1 79B SECT 80B ION 1--POLICIES AND GUIDELINES Introduction

Acknowledgments ................................................................................................................................. 1.1 Eligibility ................................................................................................................................................ 1.1 Additional Notes Regarding Application of the List ............................................................................... 1.1 Legend .................................................................................................................................................. 1.3 Example of Drug Product Listings......................................................................................................... 1.4 Drug Reviews ........................................................................................................................................ 1.5 Alberta Health Expert Committee on Drug Evaluation and Therapeutics ............................................ 1.7

Submissions for Drug Reviews

Submissions for Drug Reviews ............................................................................................................. 1.8 Criteria for Listing Drug Products ........................................................................................................ 1.10 Interchangeable Drug Products ? Additional Criteria.......................................................................... 1.12 Interchangeable Drug Products ? Additional Criteria Appendices...................................................... 1.17 Review of Benefit Status (ROBS) Criteria........................................................................................... 1.22 Submission Requirements .................................................................................................................. 1.23 Non-Innovator Policy........................................................................................................................... 1.43 Supply Shortages ................................................................................................................................ 1.45 Units of Issue for Pricing ..................................................................................................................... 1.46 Policy for Administering Interchangeability Challenges ...................................................................... 1.48 Your Comments Disclosure for Potential Conflicts of Interest ............................................................ 1.50

Restricted Benefits

Restricted Benefits .............................................................................................................................. 1.51 Products Designated as Restricted Benefits ...................................................................................... 1.51 Limited Restricted Benefits ................................................................................................................. 1.54

Special Authorization Guidelines

Special Authorization Policy................................................................................................................ 1.55 Special Authorization Procedures ....................................................................................................... 1A.1 Special Authorization Forms ............................................................................................................... 1A.2 Prescriber Registration Forms ............................................................................................................ 1A.6 Drug Special Authorization Request Form.......................................................................................... 1A.7 Donepezil/Galantamine/Rivastigmine Special Authorization Request Form ...................................... 1A.9 Darbepoetin/Epoetin Special Authorization Request Form .............................................................. 1A.11 Abatacept/Adalimumab/Anakinra/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/ Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form ................... 1A.14 Peginterferon Alfa-2a for Chronic Hepatitis C Special Authorization Request Form........................1A.16 Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form ............................................................................................................. 1A.18 Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form .................................................................... 1A.20 Select Quinolones Special Authorization Request Form .................................................................. 1A.22 Alendronate/Raloxifene/Risedronate for Osteoporosis Special Authorization Request Form..........1A.25

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

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ALBERTA DRUG BENEFIT LIST

Table of Contents, continued

Celecoxib Special Authorization Request Form ............................................................................... 1A.27 Filgrastim/Pegfilgrastim/Plerixafor Special Authorization Request Form ......................................... 1A.29 Fentanyl Special Authorization Request Form ................................................................................. 1A.32 Adalimumab/Etanercept/Infliximab/Ixekizumab/Risankizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form .................................................................... 1A.34 Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form .............................................................................. 1A.37 Adalimumab/Vedolizumab for Crohn's/Infliximab for Crohn's/Fistulizing Crohn's Disease Special Authorization Request Form ................................................................................................ 1A.39 Rituximab for Rheumatoid Arthritis Special Authorization Request Form ........................................ 1A.41 Imiquimod Special Authorization Request Form............................................................................... 1A.43 Aripiprazole/Paliperidone/Risperidone Prolonged Release Injection Special Authorization Request Form ................................................................................................................................... 1A.45 Abatacept for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form ......... 1A.48 Montelukast/Zafirlukast Special Authorization Request Form ........................................................... 1A.49 Febuxostat Special Authorization Request Form .............................................................................. 1A.51 Denosumab/Zoledronic Acid for Osteoperosis Special Authorization Request Form .......................1A.53 Omalizumab for Asthma Special Authorization Request Form ......................................................... 1A.55 Eculizumab Special Authorization Request Form..............................................................................1A.57 Eculizumab Consent Form.................................................................................................................1A.62 Rituximab for Granulomatosis with Polyangiitis/Microscopic Polyangiitis Special Authorization Request Form .............................................................................................................. 1A.64 Tocilizumab for Systemic Juvenile Idiopathic Arthritis Special Authorization Request Form ................................................................................................................................................... 1A.66 DPP-4/SGLT2 Inhibitors Special Authorization Request Form ......................................................... 1A.68 Apixaban/Dabigatran/Edoxaban/Rivaroxaban Special Authorization Request Form ........................1A.71 Tacrolimus Topical Ointment Special Authorization Request Form .................................................. 1A.73 Dimethyl Fumarate/Glatiramer Acetate/Interferon Beta-1a/Ocrelizumab/Peginterferon Beta-1a/Teriflunomide for RRMS/Interferon Beta-1b for SPMS or RRMS Special Authorization Request Form .............................................................................................................. 1A.76 Cladribine/Fingolimod/Natalizumab for Multiple Sclerosis Special Authorization Request Form ................................................................................................................................................... 1A.78 Ivacaftor Special Authorization Request Form................................................................................... 1A.80 Adalimumab/Golimumab/Infliximab/Vedolizumab for Ulcerative Colitis Special Authorization Request Form .............................................................................................................. 1A.82 Antivirals for Chronic Hepatitis C Special Authorization Request Form ............................................ 1A.84 Proton-Pump Inhibitors Pricing Authorization Request Form ............................................................ 1A.86 Nintedanib/Pirfenidone Special Authorization Request Form............................................................1A.89 Deferiprone Special Authorization Request Form ............................................................................. 1A.92 Long-Acting Fixed-Dose Combination Products for Asthma/COPD Special Authorization Request Form .................................................................................................................................... 1A.94 Eplernone/Ivabradine/Sacubitril+Valsartan Special Authorization Request Form.............................1A.97 Adalimumab for Hidradenitis Suppurativa Special Authorization Request Form...............................1A.100 Omalizumab for Chronic Idiopathic Urticaria Special Authorization Request Form .......................... 1A.102 Benralizumab/Mepolizumab Special Authorization Request Form....................................................1A.105 Alirocumab/Evolocumab for HeFH Special Authorization Request Form..........................................1A.107 Fidaxomicin Special Authorization Request Form ............................................................................. 1A.109 Asfotase Alfa Special Authorization Request Form .......................................................................... 1A.111 Asfotase Alfa Consent Form .............................................................................................................. 1A.116 Tocilizumab for Giant Cell Arteritis Special Authorization Request Form..........................................1A.118 Nusinersen Special Authorization Request Form .............................................................................. 1A.120 Obeticholic Acid Special Authorization Request Form ...................................................................... 1A.122

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

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Ocrelizumab for PPMS Special Authorization Request Form............................................................1A.125 Levodopa/Carbidopa Intestinal Gel Special Authorization Request Form.........................................1A.127 Velaglucerase Alfa/Taliglucerase Alfa for Gaucher Disease Special Authorization Request Form .................................................................................................................................... 1A.130 Migalastat Special Authorization Request Form ................................................................................ 1A.133 Single Entity Angiotensin-Converting Enzyme Inhibitors Pricing Authorization Request Form ................................................................................................................................................... 1A.136 Calcium Channel Blocking Agents (CCBs) Pricing Authorization Request Form..............................1A.139 HMG-COA Reductase Inhibitors (Statins) Pricing Authorization Request Form ............................... 1A.142 Combination Angiotensin-Converting Enzyme Inhibitors Pricing Authorization Request Form ................................................................................................................................................... 1A.145 Biosimilar Initiative Exception Special Authorization Request Form ................................................. 1A.148 Alemtuzumab for Multiple Sclerosis Special Authorization Request Form........................................1A.150 Edaravone Special Authorization Request Form ............................................................................... 1A.152 Rivaroxaban 2.5 mg Special Authorization Request Form ................................................................ 1A.154 Icatibant/Lanadelumab for HAE Type I or II Special Authorization Request Form............................1A.156 Inotersen/Patisiran for HATTR-PN Special Authorization Request Form..........................................1A.159 Registration for MS Neurologist Status Form .................................................................................... 1A.162 Application for Registered Prescriber Status for Restricted Benefit Claim Coverage under Alberta Government Sponsored Drug Benefit Programs ? Jetrea Form.................................1A.164 Opioid Agonist Therapy Program Extension Request Form..............................................................1A.167

SECTION 2--PRICE POLICY

Definitions ............................................................................................................................................. 2.1 Alberta Price Confirmation (APC) for Non-Fixed Price, Fixed Price and Pan-Canadian Select Molecule Price Initiative Drug Products ................................................................................................ 2.4 Interim APC ........................................................................................................................................... 2.6 Fixed Pricing Rules ............................................................................................................................... 2.7 Non-Fixed Pricing Rules ....................................................................................................................... 2.8 Exceptions............................................................................................................................................. 2.9 Price Reductions ................................................................................................................................. 2.11 Minister's Authority .............................................................................................................................. 2.11 Least Cost Alternative (LCA) Price Policy........................................................................................... 2.14 Maximum Allowable (MAC) Price Policy............................................................................................. 2.15 Transitional Period Price Policy .......................................................................................................... 2.16

SECTION 3--CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS

Special Authorization Policy.................................................................................................................. 3.1 Criteria for Coverage ............................................................................................................................. 3.3

SECTION 83B4 3A-- CRITERIA FOR OPTIONAL SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS

Criteria for Coverage .............................................................................................................................. 3A Role of the Prescribers........................................................................................................................... 3A Registration for Designated Prescriber Status for Alberta Drug Benefit List Claim Coverage ? Select Quinolone Antibiotics Form...................................................................................................... 3A.1

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

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Table of Contents, continued

SECTION 4--RARE DISEASES DRUG COVERAGE PROGRAM

Rare Diseases Drug Coverage ............................................................................................................. 4.1 Contraindications .................................................................................................................................. 4.1 Rare Diseases Drugs Eligible for Coverage ......................................................................................... 4.2 Alberta Rare Diseases Clinical Review Panel ...................................................................................... 4.2 Process for Rare Diseases Drug Coverage.......................................................................................... 4.2

PART 2

86BPHARMACOLOGIC?THERAPEUTIC CLASSIFICATION OF DRUGS

00:00 04:00 08:00 10:00 12:00 20:00 24:00 28:00 34:00 36:00 40:00 48:00 52:00 56:00 60:00 64:00 68:00 80:00 84:00 86:00 88:00 92:00 94:00

Non-Classified Drugs......................................................................................................1 Antihistamine Drugs ....................................................................................................... 3 Anti-Infective Agents.......................................................................................................5 Antineoplastic Agents ................................................................................................... 25 Autonomic Drugs .......................................................................................................... 27 Blood Formulation, Coagulation and Thrombosis ........................................................33 Cardiovascular Drugs ................................................................................................... 37 Central Nervous System Agents ..................................................................................77 Dental Agents ............................................................................................................. 133 Diagnostic Agents.......................................................................................................135 Electrolytic, Caloric, and Water Balance ....................................................................137 Respiratory Tract Agents............................................................................................141 Eye, Ear, Nose and Throat (EENT) Preparations ......................................................143 Gastrointestinal Drugs ................................................................................................ 155 Gold Compounds........................................................................................................165 Heavy Metal Antagonists............................................................................................167 Hormones and Synthetic Substitutes .........................................................................169 Serums, Toxoids and Vaccines ..................................................................................183 Skin and Mucous Membrane Agents .........................................................................185 Smooth Muscle Relaxants .......................................................................................... 197 Vitamins ...................................................................................................................... 199 Miscellaneous Therapeutic Agents ............................................................................201 Devices ....................................................................................................................... 207

87BAPPENDICES

Appendix 1 Abbreviations ............................................................................................................. 208 Appendix 2 Pharmaceutical Manufacturers..................................................................................209

INDICES

Index 1 Alphabetical List of Pharmaceutical Products ..................................................................N/A Index 2 Numerical List by Drug Identification Number ..................................................................N/A

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

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Section 1 Policies and Guidelines

PART 1 SECTION 1

Policies and

Guidelines

INTRODUCTION

ALBERTA DRUG BENEFIT LIST

Acknowledgments

Alberta Health acknowledges the important role Alberta Blue Cross continues to play in the production of the List and in the development of an overall strategy and initiatives to better manage Alberta Health sponsored drug programs.

Eligibility

The Alberta Drug Benefit List (the "List" or "ADBL") defines the Drug Products and Devices that are covered by Alberta government-sponsored drug programs. These programs are for Albertans and their dependents who are covered by:

1. the Alberta Blue Cross Non-Group Coverage (Group 1) offered by the Alberta Health Care Insurance Plan, or

2. the Alberta Blue Cross Coverage for Seniors (Group 66) provided to all Alberta senior citizens, or

3. the drug coverage provided to individuals approved by Alberta Health for Palliative Coverage. (For these individuals the Palliative Coverage Drug Benefit Supplement must also be considered), or

4. the drug coverage provided to Alberta Human Services clients. (For these clients the Alberta Human Services Drug Benefit Supplement must also be considered.)

Additional Notes Regarding Application of the List

1. The List is not intended to be used as a scientific reference or prescribing guide.

2. Formularies used by hospitals and continuing care facilities are developed independently of the List.

3. Drugs are classified according to the Pharmacologic?Therapeutic Classification (PTC) developed by the American Society of Health-System Pharmacists for the purpose of the American Hospital Formulary Service.

Permission to use this system has been granted by the American Society of HealthSystem Pharmacists. The Society is not responsible for the accuracy of transpositions or excerpts from the original content.

Where necessary, additional PTCs may have been assigned by Alberta Health to facilitate product location in the List.

4. Where appropriate, the Compendium of Pharmaceuticals and Specialties, published by the Canadian Pharmacist's Association, was used as a reference source for the trade name, generic name, Manufacturer, strength and dosage form.

The Canadian Pharmacist's Association is not responsible for the accuracy of transpositions or excerpts from the original content. 5. Other reference sources used for the trade name, generic name, manufacturer, strength

and dosage form are: Completed Drug Notification Form (DNF) Notice of Compliance (NOC) Product Monograph

The DBL is not a prescribing or a diagnostic tool. Prescribers should refer to drug monographs and utilize professional judgment.

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Section 1 ? 1

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