DRUG BENEFIT LIST - Canada

1 NON-INSURED HEALTH benefits . First Nations and Inuit Health Branch DRUG BENEFIT LIST. Fall 2017. 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: Health Canada Non-Insured Health benefits INTRODUCTION. Drug BENEFIT List Effective Fall 2017. Introduction to NIHB Drug BENEFIT List Effective Fall 2017. 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 Criteria ..vi C. Open benefits ..vii D. Limited Use benefits .. vii E. Exception Criteria .. vii F. viii 5. Policies .. viii A. Best Price Alternative and Interchangeability.

2 Viii B. No Substitution Claims .. viii C. Prescription Quantities .. viii D. Short Term Dispensing .. ix 6. Special Formulary for Chronic Renal Failure Patients .. x 7. Palliative Care Formulary .. x 8. Drug Utilization Evaluation .. x 9. General Information .. xi 10. NIHB Privacy Code .. xi 11. Pharmacologic-Therapeutic Classification of Drugs .. xi xii Drug BENEFIT List 04:00 Antihistamine Drugs .. 1. 08:00 Anti-Infective Agents .. 2. 10:00 Antineoplastic 17. 12:00 Autonomic Drugs .. 22. 20:00 Blood Formation and Coagulation .. 30. 24:00 Cardiovascular 34. 28:00 Central Nervous System Agents .. 56. 32:00 Contraceptives (Non-Oral) .. 93. 36:00 Diagnostic Agents .. 94. 40:00 Electrolytic, Caloric and Water Balance .. 96. 48:00 Respiratory Tract Agents .. 100. 52:00 Eye, Ear, Nose and Throat Preparations .. 103. 56:00 Gastrointestinal 109.

3 60:00 Gold Compounds .. 116. 64:00 Heavy Metal Antagonists .. 117. 68:00 Hormones and Synthetic Substitutes .. 118. 72:00 Local Anesthetics .. 128. 84:00 Skin and Mucous Membrane Agents .. 129. 86:00 Smooth Muscle Relaxants .. 136. 88:00 Vitamins .. 138. 92:00 Unclassified Therapeutic Agents .. 141. 94:00 Devices .. 149. 96:00 Pharmaceutical Aids .. 154. Appendix A (Limited Use benefits and Criteria) ..A-1. Appendix B (Special Formulary for Chronic Renal Failure Patients) .. B-1. Appendix C (Palliative Care Formulary) .. C-1. Appendix D (List of Drug Manufacturers) .. D-1. Appendix E (List of Exclusions) .. E-1. Appendix F (New Listings) .. F-1. Alphabetical Index of drug products .. I-1. ii Introduction to NIHB Drug BENEFIT List Effective Fall 2017. 1. BACKGROUND ON NON-INSURED HEALTH benefits (NIHB) PROGRAM. The Non-Insured Health benefits (NIHB) Program of Health Canada provides coverage for approximately 824,033 eligible registered First Nations and recognized Inuit with a limited range of medically necessary health-related goods and services not provided through private or provincial/territorial health insurance plans.

4 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 (DBL). The Drug BENEFIT List (DBL) is a listing of the drugs provided as benefits by the NIHB Program.

5 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).

6 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.

7 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 in section Paper (binder) versions of drug submissions are no longer accepted by the NIHB Program. Line Extensions, Generics and All Other Submissions Submissions for line extensions, generics and all other submissions are reviewed internally or by 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. iii Introduction to NIHB Drug BENEFIT List Effective Fall 2017. Drugs and Therapeutics Advisory Committee (DTAC). The DTAC provides formulary listing recommendations for drug products to the NIHB Program.

8 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.

9 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.

10 - The World Health Organization's Anatomical Therapeutic Chemical (ATC) Classification Pricing and Marketing Information The manufacturer must submit current price information for the drug product. Manufacturers are required to notify the NIHB Program of any significant change to listed drug products. Significant changes include changes in DIN, product name, manufacturer or distributor, indication, product monograph, packaging, formulation, manufacturing specifications or discontinuation of a product. Notification of changes should be provided electronically to the NIHB. Program. All submissions for drug products, to be reviewed for inclusion on the NIHB DBL, must be sent to the NIHB Program electronically. Please send all drug submissions to the following email address: Submissions will also be accepted on compact CD when mailed to the following address: C/o Manager of Policy Development - Pharmacy Non-Insured Health benefits First Nations and Inuit Health Branch, Health Canada 200 Eglantine Driveway, 9th Floor Postal Locator 1909D Tunney's Pasture Ottawa, Ontario K1A 0K9.