C8. Review Process

The review process for drug products that are considered for inclusion as a benefit under the Non-Insured Health Benefits (NIHB) Program varies depending on the type of drug submitted. The process is different depending on whether the product represents a new chemical entity or new combination drug product, or does not.

C8.1. New Chemical Entities / New Combination Drug Products

As of September 1, 2003, submissions for new chemical entities and new combination drug products 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 and forwarded to the Canadian Expert Drug Advisory Committee (CEDAC) 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 CEDAC recommendations and other specific relevant factors, such as mandate, priorities and resources.

Please refer to the Canadian Agency for Drugs and Technologies in Health (CADTH) for a list of requirements for manufacturers' submissions and a summary of procedures for the Common Drug Review Process.

C8.2. Drug Products other than New Chemical Entities / New Combination Drug Products

Submission Requirements
All submissions for drug products that are not new chemical entities or new combination drug products must be submitted to the NIHB Program. Only drug products with a Health Canada Notice of Compliance will be considered for provision as a benefit.

Letter of authorization

The manufacturer will supply the NIHB Program with a letter authorizing the NIHB Program to gain access to all information with respect to the product in the procession of the Health Canada or of the government of any province or territory in Canada, Patented Medicine Prices Review Board (PMPRB) or Canadian Agency for Drugs and Technologies in Health (CADTH).

Justification for Consideration of Listing

A statement indicating the reason for and evidence to justify the provision of the new strength, formulation, reformulation or indication of the drug product as a benefit under the NIHB Program.

Bibliography

A complete bibliography should be included.

Clinical Information

Clinical information should include:

• Reprints of clinical studies and data comparing product to current therapies;
• Studies published in peer-reviewed journals, or accepted for publication in such journals;
• Clinical data should clearly demonstrate the efficacy, toxicities, advantages and disadvantages of the drug;
• Comparative studies, showing the specific advantages of the drug, should be included; and
• Search strategies used to locate published studies in medical literature databases (for example, Medline, EMBase) should be included.

General Information

Additional information should include:

• Evidence of approval by Health Canada, including a Notice of Compliance (NOC) and Drug Identification Number (DIN);
• Product Monograph; and
• Two therapeutic classifications:
  1. American Hospital Formulary Service (AHFS) Pharmacologic -- Therapeutic Classification and;
  2. The World Health Organization's Anatomical Therapeutic Chemical (ATC) classification.

Pricing and Marketing Information

The manufacturer should submit current price information for the drug product. Materials used for marketing products to physicians and pharmacists may be submitted also.

Economic Information

A complete Budget Impact Assessment on anticipated costs to the NIHB Program must be included.

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 to the address below.

Submissions should be sent to Benefit Management - Non-Insured Health Benefits, c/o Director.

Only ONE copy of the submission is required.

Receipt of submission will be acknowledged by letter.

C8.3. Drug Review Process

The review process for drug products vary depending on the type of drug product under review. Existing drug products with new indications and line extension drug products are reviewed internally and referred to the Federal Pharmacy and Therapeutics Committee for recommendations on formulary listing to the NIHB Program and other participating federal drug plans.

Other drug products, such as generic drug products, are reviewed internally. Generic drug products are considered for inclusion on the formulary based on provincial interchangeability lists and other relevant factors.

C8.4. Federal Pharmacy and Therapeutics Committee

The Federal Pharmacy and Therapeutics (FP&T) Committee provides formulary listing recommendations for drugs products to participating federal drug plans, including the NIHB Program. The NIHB Program and other federal drug plans make listing decisions based on FP&T Committee recommendations and other specific relevant factors, such as mandate, priorities and resources.

The Federal Pharmacy and Therapeutics (FP&T) Committee is an advisory body of health professionals established to provide evidence based pharmacy and medical advice to the drug benefit plans of six federal departments (Health Canada, Veterans Affairs, Royal Canadian Mounted Police, Correctional Services Canada, National Defence and Citizenship and Immigration Canada).