Ontario Drug Benefit : How Drugs are Approved

A drug manufacturer must submit its new drug product to the federal government's Health Products and Food Branch (HPFB) at Health Canada, for review and approval. The HPFB is responsible for approving a drug for sale and marketing anywhere in Canada.

The HPFB evaluates a product's safety and efficacy and looks at a large volume of research including animal efficacy and toxicology studies. The federal review process can take between one and two years, depending on the nature of the product.

Once Health Canada approves the product for sale in Canada, a Notice of Compliance (NOC) and a Drug Identification Number (DIN) for the product will be issued.

After Health Canada issues an NOC, to be considered for funding under most governments' drug plans, a manufacturer must file a submission to the national Common Drug Review (CDR) process. The CDR is a single process for undertaking reviews and providing common listing recommendations for new drugs (new chemical entities and new combination products), based on rigorous clinical and pharmacoeconomic reviews, to participating federal, provincial and territorial (F/P/T) drug benefit plans in Canada. All jurisdictions are participating except Québec.

The CDR is housed by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). It receives expert advice from the Canadian Expert Drug Advisory Committee (CEDAC) which makes recommendations to the partnering jurisdictions regarding coverage.

Since September 1, 2003, all submissions to consider coverage of new drugs on provincial formularies must first be reviewed through the national CDR process.

It should be noted that approval of a product for marketing by Health Canada does not automatically mean that it will be listed as a benefit under the ODB program. It is the drug manufacturer's responsibility to seek listing on the Formulary/CDI by filing a complete submission to the ministry's Drug Programs Branch for review by the ministry's expert advisory committee, the Drug Quality and Therapeutics Committee (DQTC) for all drug products, including those going through the CDR process. All new drugs to be considered for funding under the ODB have to go through the CDR process, with a recommendation by CEDAC and a subsequent review and recommendation by the DQTC to the Ministry.

Factors that may be considered by the DQTC and/or ministry once a CEDAC recommendation is made include fiscal capacity, current Formulary listings, the need for clinical criteria and the population served by the ODB programs.

Those products that do not go through the CDR process (e.g., old drug products, new strengths, new formats, etc.) are reviewed by the DQTC who then makes a recommendation to the Ministry.

Listing recommendations can include whether individual drug products should be listed in the Ontario Drug Benefit Formulary as either a general benefit or a Limited Use (LU) benefit, or be considered for coverage under the ODB program's Individual Clinical Review (ICR) mechanism on a case by case basis, or should not be considered for coverage under the ODB program at all.

Once a product has been recommended for listing by the DQTC, the ministry then works with the manufacturer to achieve appropriate utilization and optimal cost management by establishing written agreements for single source products (brand name products). The agreements are required for all new single source products to be listed on the Formulary.

Recommendations for Formulary listings along with expenditure forecasts are then forwarded to the government's Management Board of Cabinet, Legislation and Regulations Committee and finally to Cabinet for final approval.

Streamlined Submissions
The ministry has harmonized its generic drug submission review process with that of Health Canada, such that 80% of submissions no longer require review by the DQTC. Submissions for these products are still required to meet the general submission requirements, as defined in regulation, prior to being forwarded to the government for final approval.

Non-Streamlined Submissions
All "non-streamlined submissions" are reviewed by the DQTC, similar to the process for "new drug" reviews.

The ministry endeavours to issue monthly updates for generic Formulary listings in addition to the standard Formulary Updates.

For more information about how drugs are approved for coverage in Ontario, please contact the Drug Programs Branch, at 416-327-8109.