Drug Benefit List

1 Non-Insured Health Benefits First Nations and Inuit Health Branch drug Benefit List September 2020. PLEASE NOTE: This PDF version of the drug Benefit List (DBL) does not have the most up-to-date listing information as it cannot be updated as frequently as the search tool. For current information please refer to the NIHB DBL. search tool on the ESC website, updated daily: The Non-Insured Health Benefits (NIHB) program provides supplementary health benefits, including prescription and non-prescription drugs, for registered First Nations and recognized Inuit throughout Canada. Visit our Web site at: Current DBL is available at Department of Indigenous Services Canada Non-Insured Health Benefits Introduction drug Benefit List Effective September 2020. Current DBL is available at Introduction to NIHB drug Benefit List Effective September 2020.

2 Table of Contents 1. Background on NIHB Program ..iii 2. Purpose of the NIHB drug Benefit List ..iii 3. drug review process ..iii 4. Benefit criteria .. v A. drug Benefit listings .. v B. Deletion C. Open benefits ..vi D. Limited use E. Exception criteria ..vii F. Exclusions ..vii 5. Policies .. viii A. Best price alternative and viii B. No substitution claims .. viii C. Prescription quantities .. viii D. Short term dispensing .. viii 6. Formulary for chronic renal failure 7. End of life care formulary .. x 8. Formulary for adjunct medications used during active cancer treatment .. x 9. Nutrition supplement formulary .. x 10. drug utilization evaluation ..xi 11. General 12. NIHB privacy code ..xi 13. Pharmacologic-therapeutic classification of Legend ..xii drug Benefit List 04:00 Antihistamine drugs .. 1. 08:00 Anti-Infective agents.

3 2. 10:00 Antineoplastic agents .. 16. 12:00 Autonomic drugs .. 28. 20:00 Blood formation and coagulation .. 36. 24:00 Cardiovascular drugs .. 41. 28:00 Central nervous system agents .. 64. 32:00 Contraceptives (non-oral) .. 103. 36:00 Diagnostic 104. 40:00 Electrolytic, caloric and water 106. 48:00 Respiratory tract agents .. 111. 52:00 Eye, ear, nose and throat preparations .. 114. 56:00 Gastrointestinal drugs .. 120. 60:00 Gold compounds .. 128. 64:00 Heavy metal 129. 68:00 Hormones and synthetic substitutes .. 130. 72:00 Local anesthetics .. 140. 84:00 Skin and mucous membrane agents .. 142. 86:00 Smooth muscle 150. 88:00 Vitamins .. 152. 92:00 Unclassified therapeutic agents .. 155. 94:00 Devices .. 167. 96:00 Pharmaceutical 173. Appendix A (limited use benefits and criteria)..A-1. Appendix B (formulary for chronic renal failure patients).

4 B-1. Appendix C (end of life care formulary) .. C-1. Appendix D (formulary for adjunct medications used during active cancer treatment) .. D-1. Appendix E (extemporaneous mixtures) ..E-1. Appendix F (list of drug manufacturers)..F-1. Appendix G (list of exclusions) .. G-1. Appendix H (new listings) .. H-1. Appendix I (nutritional products formulary) .. I-1. Alphabetical index of drug products .. Index-1. ii Current DBL is available at Introduction to NIHB drug Benefit List Effective September 2020. 1. Background on Non-Insured Health Benefits (NIHB) Program The Non-Insured Health Benefits (NIHB) Program of the Department of Indigenous Services Canada provides clients (registered First Nations and recognized Inuit) with coverage for a range of health benefits, including prescription drugs and over-the-counter medications, dental and vision care, medical supplies and equipment, mental health counselling, and transportation to access health services not available locally.

5 These benefits complement provincial and territorial health care programs, such as physician and hospital care, as well as other First Nations and Inuit community-based programs and services. Benefits include drugs, medical transportation, dental care, medical supplies and equipment, crisis intervention counselling and vision care. The authority for the NIHB Program is based on the 1979 Indian Health Policy which describes the responsibility for the health of First Nations as shared amongst various levels of government, the private sector and First Nations communities. As a result of this shared responsibility, when a Benefit is covered under another plan, the federal government requires the coordination of benefits to ensure that the other plan meets its obligations. 2. Purpose of the NIHB drug Benefit List The drug Benefit List (DBL) is a listing of the drugs provided as benefits by the NIHB Program.

6 The DBL. is updated regularly and published regularly. The listed drugs are those primarily used in a home or ambulatory setting. A prescription from a licensed practitioner is required for any listed drug to be processed as a Benefit . Practitioners are health professionals authorized to prescribe drugs within the scope of practice in their province or territory. The DBL is a tool for prescribers and pharmacists that encourages the selection of optimal, cost-effective drug therapy. 3. drug review process The review process for drug products that are considered for inclusion as a Benefit under the NIHB. Program varies depending on the type of drug submitted. New chemical entities / new combination drug products/ existing chemical entities with new Indication Submissions for new chemical entities, new combination drug products and existing chemical entities with new indications, must be sent to the Canadian Agency for Drugs and Technologies in Health (CADTH).

7 Clinical and pharmacoeconomic reviews are coordinated by the Common drug Review (CDR) Directorate, or by the pan-Canadian Oncology drug Review (pCODR) for cancer therapies, and forwarded to their respective expert committees for recommendations on formulary listing . These recommendations are forwarded to participating drug plans, including the NIHB. Program, for consideration. The NIHB Program and other drug plans make listing decisions based on these expert committee recommendations and other specific relevant factors, such as mandate, priorities and resources. Please refer to CADTH for a list of requirements for manufacturers' submissions and a summary of procedures for the CDR or pCODR process. Inquiries should be directed to: Canadian Agency for Drugs and Technologies in Health 865 Carling Avenue, Suite 600. Ottawa, Ontario K1S 5S8.

8 Telephone: (613) 226-2553. Website: Please ensure a copy of the complete submission is also sent to NIHB either electronically to or on compact CD to the mailing address indicated insection Paper (binder) versions of drug submissions are no longer accepted by the NIHBP rogram. Line extensions, generics and all other submissions Submissions for line extensions, generics and all other submissions are reviewed internally or by iii Current DBL is available at Introduction to NIHB drug Benefit List Effective September 2020. the NIHB Drugs and Therapeutics Advisory Committee (DTAC). Generic drug products are considered for inclusion on the formulary based on provincial interchangeability lists and other relevant factors. Drugs and Therapeutics Advisory Committee (DTAC). The DTAC provides formulary listing recommendations for drug products to the NIHB.

9 Program. The NIHB Program makes listing decisions based on DTAC recommendations and other specific relevant factors, such as mandate, priorities and resources. The DTAC. also contributes to the NIHB drug Use Evaluation (DUE) Program which promotes safe, therapeutically effective and efficient use of drug therapy for First Nations and Inuit. The DTAC is an advisory body of highly qualified health professionals who bring impartial and practical expert medical and pharmaceutical advice to the NIHB Program to promote improvement in the health outcomes of First Nations and Inuit clients through effective use of pharmaceuticals. The approach is evidence-based and the advice reflects medical and scientific knowledge, current utilization trends, current clinical practice, health care delivery and specific departmental client healthcare needs.

10 Submission requirements All submissions for drug products that are line extensions, generics and all other types of submissions must be submitted to the NIHB Program. Only drug products with a Health Canada Notice of Compliance (NOC) will be considered for provision as a Benefit . Letter of authorization The manufacturer will provide a letter authorizing the NIHB Program to gain access to all information with respect to the product in the possession of Health Canada or of the government of any provinces or territory in Canada, Patented Medicine Prices Review Board (PMPRB) or CADTH. Justification for consideration of listing The manufacturer will provide a statement indicating the rationale and evidence to justify the provision of the new product. General information Additional information should include: Evidence of approval by Health Canada, such as a Notice of Compliance (NOC) and drug Identification Number (DIN) and Two therapeutic Classifications: - American Hospital Formulary Service (AHFS) Pharmacologic Therapeutic Classification and.