Non-Insured Health Benefits - Drug Benefit List Fall 2017
Organization: Health Canada
Table of Contents
- 1. Background on NIHB Program
- 2. Purpose of the NIHB Drug Benefit List
- 3. Drug Review Process
- 4. Benefit Criteria
- 5. Policies
- 6. Special Formulary for Chronic Renal Failure Patients
- 7. Palliative Care Formulary
- 8. Drug Utilization Evaluation
- 9. General Information
- 10. NIHB Privacy Code
- 11. Pharmacologic-Therapeutic Classification of Drugs
- Drug Benefit List
- 04:00 Antihistamine Drugs
- 08:00 Anti-Infective Agents
- 10:00 Antineoplastic Agents
- 12:00 Autonomic Drugs
- 20:00 Blood Formation and Coagulation
- 24:00 Cardiovascular Drugs
- 28:00 Central Nervous System Agents
- 32:00 Contraceptives (Non-Oral)
- 36:00 Diagnostic Agents
- 40:00 Electrolytic, Caloric and Water Balance
- 48:00 Respiratory Tract Agents
- 52:00 Eye, Ear, Nose and Throat Preparations
- 56:00 Gastrointestinal Drugs
- 60:00 Gold Compounds
- 64:00 Heavy Metal Antagonists
- 68:00 Hormones and Synthetic Substitutes
- 72:00 Local Anesthetics
- 84:00 Skin and Mucous Membrane Agents
- 86:00 Smooth Muscle Relaxants
- 88:00 Vitamins
- 92:00 Unclassified Therapeutic Agents
- 94:00 Devices
- 96:00 Pharmaceutical Aids
- Appendix A (Limited Use Benefits and Criteria)
- Appendix B (Special Formulary for Chronic Renal Failure Patients)
- Appendix C (Palliative Care Formulary)
- Appendix D (List of Drug Manufacturers)
- Appendix E (List of Exclusions)
- Appendix F - New Listings
- Alphabetical Index of Drug Products
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. 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. 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.
3.1 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). 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
Telephone: (613) 226-2553
Please ensure a copy of the complete submission is also sent to NIHB either electronically to NIHB.Drug.Submisions@hc-sc.gc.ca or on compact CD to the mailing address indicated in section 18.104.22.168. Paper (binder) versions of drug submissions are no longer accepted by the NIHB Program.
3.2 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.
3.2.1 Drugs and Therapeutics Advisory Committee (DTAC)
The DTAC provides formulary listing recommendations for drug products to the NIHB 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.
3.2.2 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.
22.214.171.124 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.
126.96.36.199 Justification for Consideration of Listing
The manufacturer will provide a statement indicating the rationale and evidence to justify the provision of the new product.
188.8.131.52 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;
- The World Health Organization’s Anatomical Therapeutic Chemical (ATC) Classification
184.108.40.206 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: NIHB.Drug.Submissions@hc-sc.gc.ca. 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
Only ONE copy of the submission is required. Receipt of submission will be acknowledged electronically with a confirmatory email message. Paper (binder) versions of drug submissions are no longer accepted by the NIHB Program.
4. Benefit Criteria
The following criteria are the framework for the NIHB Program DBL. The criteria provide the basis for decisions about drugs on the formulary relating to:
- Drug Benefit Listings
- Open Benefit
- Limited Use
All drugs that are to be either considered for listing or currently listed as Program benefits must, as a minimum:
- be legally available for sale in Canada with an NOC;
- be sold in Canada (proof may include a copy of the completed notification form issued under the Food and Drug Regulations or listing on a provincial drug benefit formulary);
- be administered in a home setting or in other ambulatory care settings;
- not be provided in a provincially/territorially covered setting (hospital/institution) or provided through provincially/territorial covered programs or clinics according to provincial/territorial legislation; and
- be in accordance with NIHB Program mandate and policies.
A. Drug Benefit Listings
The NIHB Program, with assistance from the CDR, pCODR and the NIHB DTAC, balances a number of factors in making listing decisions about changes to the Drug Benefit List, such as:
- The needs of First Nations and Inuit clients;
- Accumulated scientific and clinical research on currently-listed drugs;
- Cost-benefit analysis;
- Availability of alternatives;
- Current health practices; and
- Policies and listings in provincial drug formularies.
New formulations and new strengths of listed products may be added or may replace previously approved products.
Generic products are added according to provincial/territorial interchangeability lists and other relevant factors.
Combination products are considered for listing if:
- each component of the combination makes a contribution to the claimed effect;
- a pharmacological or pharmaceutical rationale exists for the combination;
- the dosage of each component (amount, frequency, duration) is safe and effective for a significant proportion of the patient population requiring such concurrent therapy as defined in the labeling of the drug; and
- the cost is reduced, or scientific evidence indicates that the advantages outweigh any additional cost; or
- an improvement in compliance, resulting in an increase in clinical effectiveness, is demonstrated.
Long Acting (Sustained-Extended Release) Products may be listed when:
- clinical studies have demonstrated the safety and efficacy of the active ingredient when administered in the long acting form; and
- a therapeutic advantage is demonstrated in the treatment of the disease entity for which the product is indicated (therapeutic advantage is defined as: improved efficacy relative to the conventional dosage with no increase in toxicity; or less toxicity with improved or similar efficacy); or
- there is demonstrated improvement in compliance resulting in an increase in clinical effectiveness; or
- there is evidence that the long acting product is at least as cost-effective as the best price alternative in the conventional form that is currently covered; or
- there is no suitable conventional dosage form(s) of the drug listed that is readily available.
Injectable Drug Products will be considered if they are:
- self-administered in a home or other ambulatory setting;
- not part of a physician’s standard office supply;
- not provided in a provincially/territorially covered hospital or institution; or
- not provided through provincially/territorial covered programs or clinics according to provincial/territorial legislation.
B. Deletion Criteria
The following deletion criteria guide the removal or delisting of a drug product from the NIHB drug benefit list. Drugs are deleted:
- when a product is discontinued from the Canadian market;
- when new products possessing clearly demonstrated therapeutic and safety advantages or improvements have been listed;
- when new toxicity data shift the risk/benefit ratio to make the continued listing of the product inappropriate;
- when new information demonstrates that the product does not have the anticipated therapeutic benefit;
- when the purchase cost is disproportionate to the benefits provided; or
- when the drug has a high potential for misuse or abuse.
NOTE: Drugs may also be removed at the discretion of the Director General, NIHB Program when there are undesirable financial, supply or administrative implications to the continued listing of a product.
C. Open Benefits
Open benefits are the drugs listed in the NIHB DBL which do not have established criteria or prior approval requirements.
D. Limited Use Benefits
Limited use drugs are drug products listed on the NIHB DBL that may be inappropriate for general listing, but have value in specific circumstances. These products will have specific criteria for provision as a benefit under the NIHB Program. A product will be designated for limited use when:
- it has the potential for widespread use outside the indications for which benefit has been demonstrated;
- it has proven effectiveness, but is associated with predictable severe adverse effects;
- it is usually a second or third line choice for treatment and is required because of allergies, intolerance, treatment failure or noncompliance with a first line alternative; or
- it is very costly and a therapeutically effective alternative is available as a benefit.
There are three types of limited use benefits:
- Limited use benefits which do not require prior approval. These include but are not limited to:
- Multivitamins (which are benefits for children up to six years of age); and
- Prenatal and postnatal vitamins (which are benefits for women of childbearing age (12 to 50 years).
- Benefits which have a quantity and/or frequency limit. A maximum quantity of drug is allowed within a specified period of time. No prior approval is required for the recipient to obtain the allowable quantity of drug within the specified period. An example of a category of drugs with a quantity and frequency limit is smoking cessation products. Recipients are eligible to receive up to three treatment courses of nicotine replacement therapy (NRT) within a 12-month period with quantity limits, which include two courses of NRT patches and one course of NRT products used PRN (i.e. gums, lozenges, inhalers).
- Limited use benefits which require prior approval (using the “Limited Use Drugs Request Form”). Limited use benefits and the criteria for their coverage are identified in the Drug Benefit List and also in Appendix A. The criteria are also listed on the forms faxed to prescribers for completion.
Exception drugs are drug products which are not listed in the DBL. These drug products may be approved in special circumstances upon receipt of a completed “Exception Drugs Request Form” from the attending licensed practitioner.
- when the prescription is for a recognized clinical indication and dose which is supported by published evidence or authoritative opinion; and
- when there is significant evidence that the requested drug is superior to drugs already listed as program benefits; or
- when a patient has experienced an adverse reaction with a best- price alternative drug, and a higher cost alternative is requested by the prescriber; or
- when there is supporting evidence that available alternatives are ineffective, toxic, or contraindicated (personal preference alone does not justify an exception).
Exclusions are items not listed as benefits on the DBL and are not available through the exception or appeal processes. These include certain drug therapies for particular conditions which fall outside of the NIHB mandate and are not provided as benefits under the NIHB Program.
Examples of categories of drugs or drug products* that are not considered for coverage under the NIHB Program under any circumstances are listed in Appendix E
- Anti-obesity drugs;
- Household products (e.g. regular soaps and shampoos);
- Alternative therapies, including glucosamine and evening primrose oil;
- Drugs with investigational/experimental status;
- Medications for travel
- Hair growth stimulants;
- Fertility agents and impotence drugs;
- Selected over-the-counter products;
- Opioid containing cough preparations.
*Note: List of excluded drugs or drug products is not exhaustive and may be modified as necessary
A. Best Price Alternative and Interchangeability
The NIHB Program will reimburse only the best price (lowest cost) alternative product in a group of interchangeable drug products. Pharmacists must follow their provincial/territorial pharmacy legislation/policies to identify interchangeable products and to select the lowest-priced brand. (NIHB may not necessarily reimburse at the cost listed in the provincial drug plan formulary).
B. “No Substitution” Claims
NIHB will consider reimbursement for a higher-cost interchangeable product when a patient has experienced an adverse reaction with a lower-cost alternative. In such circumstances, the prescriber must provide the NIHB Program with:
- a completed and signed Canada Vigilance Adverse Reaction Reporting Form: ‘Report of suspected adverse reactions to health products in Canada’ and,
- the prescription with “No Substitution” or “No Sub” written by hand or typed on the prescription.
Upon receipt, the pharmacist will forward a copy of the prescription to NIHB for review. The prescriber is responsible for sending a copy of the form to the Canada Vigilance Program. Forms can be obtained by calling the Canada Vigilance Program at 1-866-234-2345 or by downloading a copy from Health Canada website at: http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php
NOTE: The Canada Vigilance Adverse Reaction Reporting Form will not need to be resubmitted for renewals or new prescriptions of the same drug for the patient, although “No Sub” will still have to be written or typed on the prescription.
C. Prescription Quantities
The normal quantity dispensed shall be the entire quantity of the drug prescribed. A maximum 100-day supply should be considered for those circumstances where the patient has been stabilized on a medication and the prescriber feels that further adjustment during the prescribed period is unlikely. Prescriptions for opioids and benzodiazepines have a maximum 30–day supply. The physician may continue to prescribe a smaller quantity with repeats at certain intervals when it is in the patient’s best interest.
D. Short Term Dispensing Policy
It is the Program’s expectation that certain medications required for long-term maintenance therapy should be prescribed and dispensed in up to 100 days supplies. For refills for medications requiring short-term dispensing for a shorter time than 28 days due to compliance concerns, the Program will only reimburse a total of one dispensing fee per 28 days up to the regional maximum of the Program. These medications include (but are not limited to) the following:
- Antiemetics for cancer chemotherapy (excluding nabilone)
- Prokinetic agents
- Synthetic antidiuretic hormone
- Respiratory smooth muscle relaxants
- Anti-dementia Drugs
- Anti-gout Drugs
- Anti-Parkinsonian Drugs
- Anti-platelet aggregation Drugs
- BPH Drugs
- Cardiovascular Drugs
- Enzyme Preparations
- Drugs for Diabetes
- Drugs for Treatment of Bone Diseases
- GI Anti-inflammatory Drugs
- Thyroid Therapy
- Proton Pump Inhibitors
- Urinary Anti-Spasmotics
- H2-Receptor Antagonists
- OTCs (including vitamins)
- Other Drugs for Peptic Ulcer and Gastro-esophageal Reflux Disease (GERD)
Note: This list may be amended as required and changes will be communicated through the quarterly on-line updates to the DBL. Medications on the Short term Dispensing list are identified in the DBL using the symbol ST beside the medication strength and dosage form.
The following are exceptions to the STD policy:
- Refills for intermittent treatment of a chronic disorder or refills of a medication which is prescribed to be taken on an “as needed” (PRN) basis. Note: Medications prescribed to be taken on an “as needed” (PRN) basis and dispensed chronically may be subject to audit and recovery.
- Prescriptions for dose changes.
- The following dosage forms: injectable and suppository.
- Refills or new prescriptions when prescribed/dispensed in accordance with a court order.
- Others as identified by the NIHB Program
The compensation will be the lesser of the usual and customary fee up to the maximum negotiated NIHB regional dispensing fee for each 28 days supplied. NIHB will continue to audit and recover in instances where quantity reduction occurs.
Less than 28 Day Supply
For the medications listed below in which short-term dispensing is deemed medically necessary, the Program will compensate up to one full dispensing fee every seven days, up to the regional maximum of the Program. If these medications are dispensed daily, the Program will compensate 1/7th of this fee:
- Hormonal Contraceptives
- Needles & Syringes
- Drug used in nicotine dependence
- Antimanic agents
- Nicotine Replacement Therapy
When filling a new prescription for a chronic use drug, the Program will pay a full dispensing fee regardless of the days supply. A new prescription may include a dosage change or an intermittent treatment, based on an assessment by a prescriber.
When refilling a prescription for a chronic use drug that is for less than a 28 day supply or when a need for compliance packaging is identified by the prescriber, the Program will pay no more than one full dispensing fee per 28 day period. For the medications listed above the Program will pay no more than full dispensing fee per 7 day period.
A refill is defined as the second and all subsequent fills for a given strength and dosage of a drug.
6. Formulary for Chronic Renal Failure Patients
Clients with chronic renal failure are eligible to receive a list of supplemental benefits that are not included in the NIHB DBL but which are required on a long-term basis. Some supplemental benefits include: darbepoetin alfa products (except in provinces where NIHB clients are eligible to receive darbepoetin alfa through the provincial programs), calcium products, multivitamins formulated for renal patients and select nutritional supplements formulated for renal patients.
New clients requiring drugs on the special formulary will be identified for coverage through the usual prior approval process. Once the client is confirmed as eligible, coverage will automatically be extended to all drugs in the special formulary for as long as needed.
7. Palliative Care Formulary
Clients diagnosed with a terminal illness and are near the end of life will be eligible to receive a list of supplemental benefits that are not included in the NIHB Drug Benefit List. The Palliative Care Formulary includes medications used to provide comfort to those near the end of life.
Requests for any of the DINs on the Palliative Care Formulary will generate a Palliative Care Application Form, faxed to the prescriber. Once completed and submitted, the recipient will be eligible for all medications on the Palliative Care Formulary for six months if the following criteria are met:
- is not receiving care in a provincially covered hospital or provincially covered long-term care facility; and
- has been diagnosed with a terminal illness or disease which is expected to be the primary cause of death within six months or less
If coverage is required beyond the initial six months, an additional six months will be granted upon receipt of another completed Palliative Care Application Form.
8. Drug Utilization Evaluation
A drug utilization evaluation, which is part of the point-of-service or on-line adjudication system, provides an analysis of both previous claims data and current claims data to identify potential drug-related problems. Messages are returned to pharmacists to alert them of the potential problems. These messages are intended to enhance pharmacy practice with additional information. Currently, the system monitors for:
- potential drug/drug interactions
- duplicate drugs
- duplicate therapy
As part of the NIHB Drug Use Evaluation (DUE) Program, DTAC reviews utilization patterns of medications billed to the NIHB program and provides advice to promote effective, efficient and optimal drug therapy to First Nations and Inuit recipients.
9. General Information
Sources of information about the NIHB Program include:
- The NIHB section of the Health Canada website which provides background information on the Program and a copy of the DBL. This can be found at: www.healthcanada.gc.ca/nihb
- NIHB DBL Updates are available to pharmacists and to prescribers via the Health Canada website. These updates can be found at: http://www.hc-sc.gc.ca/fniah-spnia/pubs/nihb-ssna/index-eng.php#drug-med
Information about the NIHB Program can also be obtained by contacting:
Non-Insured Health Benefits
First Nations and Inuit Health Branch
200 Eglantine Driveway, 9th Floor
Postal Locator 1909D
Ottawa, Ontario K1A 0K9
10. NIHB Privacy Code
The NIHB Program of Health Canada is committed to protecting an individual’s privacy and safeguarding the personal information in its possession. When a benefit request is received, the NIHB Program collects, uses, discloses and retains an individual’s personal information according to the applicable federal privacy legislation. The information collected is limited to only that information required for the NIHB Program to administer and verify benefits.
As a program of the federal government, the NIHB Program must comply with the Privacy Act, the Canadian Charter of Rights and Freedoms, the Access to Information Act, the Treasury Board of Canada Privacy and Data Protection Policies, the Government Security Policy, and Health Canada’s Security Policy.
11. Pharmacologic-therapeutic Classification of Drugs
The drugs in the NIHB DBL are classified according to the AHFS Pharmacologic-Therapeutic classification developed by the American Society of Health-System Pharmacists for the purposes of the AHFS Drug Information.
Permission to use this system has been granted by the American Society of Health-System Pharmacists. The Society is not responsible for the accuracy of transpositions from the original context.
Drugs are listed alphabetically within each therapeutic classification according to their chemical names. Under each drug, acceptable products are listed.
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