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Ministry Status: Routine Monitoring and Engagement

Ontario Public Drug Programs

How Drugs Are Approved

The ministry has put clear steps in place to consider new drugs for funding under Ontario's drug programs. Drug manufacturers must request and receive approval from:

Ontario Drug Benefit: How Drugs are Considered

Health Canada
Health Canada scientists review new drugs to check that they are safe, are of good quality, and they do what they claim to do.

Ontario Drug Benefit: How Drugs are Considered

Health Canada's Drug Review Process – for Sale and Marketing of a Drug in Canada

Before a drug product is authorized for sale in Canada the drug manufacturer must submit scientific evidence of the product's safety, efficacy and quality to Health Canada for review and approval.

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 are issued.

More details on Health Canada's process can be found on their website.

Approval of a product for marketing by Health Canada does not automatically mean that it will be funded through the Ontario Drug Benefit (ODB) Programs. It is the drug manufacturer's responsibility to seek funding through the ODB Programs by filing a complete submission to the ministry's Ontario Drug Benefit Programs for review by the ministry's expert advisory committee, the Committee to Evaluate Drugs (CED).  This applies to all drug products, including those going through the Common Drug Review (CDR) process.

Common Drug Review (CDR) For brand name drugs and for non-cancer drugs
With advice from an expert committee, the CDR recommends which drugs Ontario and other provinces and territories in Canada (except for Quebec) should fund under their public drug programs.
OR

Ontario Drug Benefit: How Drugs are Considered

Non-Cancer Drugs

Common Drug Review - for Common Listing Recommendations for New Drugs for Provincial Coverage

To be considered for funding under most public drug plans, a manufacturer must file a submission to the national CDR process. The CDR is a single process for undertaking reviews and providing common listing recommendations for new drugs (except for new cancer drugs), based on rigorous clinical and pharmacoeconomic analyses, to participating federal, provincial and territorial (F/P/T) drug benefit plans in Canada. All jurisdictions participate except Québec.

The CDR is administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). It receives expert advice from the Canadian Expert Drug Advisory Committee (CEDAC) which makes recommendations to the participating jurisdictions regarding coverage.

More details on CDR's process can be found on their website.

The Pan-Canadian Oncology Drug Review (pCODR): For cancer drugs
Reviewers consider the research and cost of new cancer drugs. They then recommend which ones Ontario and other provinces and territories in Canada (except for Quebec) should fund under their public drug programs.

Ontario Drug Benefit: How Drugs are Considered

Cancer drugs

The pan-Canadian Oncology Drug Review (pCODR) assesses cancer drugs and recommends which ones Ontario and other provinces and territories in Canada (except Quebec) should fund under their public drug programs.  The review takes up to 5-8 months to complete. There are 4 main steps:

  • pCODR works with the manufacturer or tumour group to help them prepare for the review. This includes obtaining input from the Provincial Advisory Group and patient stakeholder groups.
  • The manufacturer or tumour group submits its request for a drug review. Their submission must follow a strict set of guidelines.
  • An expert pCODR review committee considers the research data and cost of the proposed drug. This includes a review of input from the Provincial Advisory Group and other stakeholders.
  • The pCODR then recommends if the cancer drug should be publicly funded.

Learn more about the pCODR process from their website.

The final step for approval

Background:

The former Inter- Provincial Joint Oncology Drug Review Process

The Ontario Ministry of Health and Long-Term Care
The ministry's expert advisory committee reviews each manufacturer's request to fund its drug. The committee then makes a recommendation to the Executive Officer of Ontario's drug programs. The Executive Officer makes the final funding decision based on the committee's recommendation, the government's budget for drug programs, and what is in the public's best interest.

Ontario Drug Benefit: How Drugs are Considered

Ontario's Drug Review Process – for Funding through the Ontario Drug Benefit Program

Drugs funded through Ontario Drug Benefit Programs are either listed in the Ontario Drug Benefit (ODB) Formulary/Comparative Drug Index (the "Formulary") or are approved through the Exceptional Access Program (EAP).

The ministry provides drug coverage for over 4,400 quality-assured drug products to eligible recipients.  While the list of drug benefits in the Formulary is extensive, it does not include every drug, indication, strength and dosage form that a physician may prescribe.

Non-cancer drugs:

In general, all new drugs approved for use by Health Canada are first reviewed under the national CDR process. Following the release of their recommendation, it is up to each province to decide whether to fund the drug product as a benefit under its own provincial drug plan(s). 

Ontario has an established process for reviewing requests for drug funding under the public drug programs. In general, new drug products, including requests for additional strengths of existing drug products may be considered for funding in Ontario if the manufacturer makes a complete submission to the ministry. Once the ministry receives a submission and the final CDR recommendation, our provincial expert advisory committee, the Committee to Evaluate Drugs (CED), considers the Ontario context for funding and conducts a thorough assessment of the scientific evidence, clinical experience and patient perspective, as well as the impact on health services compared to existing treatments in Ontario. The CED then makes a recommendation on whether or not the drug product should be listed in the ODB Formulary or funded through the Exceptional Access Program on a case-by-case basis. The final funding decision is made based on the CED's recommendation, the overall budget and public interest.

Cancer drugs:

Generally, new cancer drugs submitted for public funding consideration in Ontario are reviewed by the CED, which works with experts from Cancer Care Ontario. This collaborative evaluation process ensures that decisions are made with input from cancer treatment experts. These experts consider a drug's clinical value and conduct a thorough assessment of the scientific and clinical evidence contained in the manufacturer's submission, as well as the impact on health services as compared to existing treatments, and make a recommendation on whether or not the drug product should be funded.  The final funding decision is made based on the CED's recommendation, the overall budget and public interest.

Generic drugs:

Generic drugs have the same active ingredient as the brand name products. Since they have the same active ingredient, generic drugs behave in the same way as brand name equivalents, they can be substituted, or become "interchangeable" with the brand name drug. Generic drugs have the same quality and efficacy as brand name drugs. Generic drugs must meet the same scientific norms and standards as brand name drugs. These standards are set by Health Canada.

Since 2005, the Ministry has harmonized its generic drug submission review process with that of Health Canada, such that 90 to 95 percent of submissions for generic drug products no longer require scientific review by the CED. Submissions for these generic drug products are still required to meet the submission requirements, before a final decision is made for each product for designation of interchangeability on the Formulary.

For the remaining generic submissions that are still required to be reviewed by the CED, they will follow the normal review process for scientific evaluation. The CED will then make a recommendation on whether or not the drug product should be designated as interchangeable.  The CED's recommendation will be taken under consideration before a final decision is made.

Final funding decisions:

The Executive Officer of the Ontario Public Drug Programs makes final drug funding decisions.  In general, the following factors are taken into consideration:

  • CED recommendation
  • Advice from other advisory bodies, e.g. Citizen's Council
  • Patient and societal impact, public interest
  • Product listing agreements with manufacturers
  • Drug program budgets
  • Other factors, e.g. government priorities

Product Listings Agreements:

A listing agreement refers to a negotiated agreement between a pharmaceutical manufacturer and the Executive Officer.  These agreements support reimbursement of some products on the Formulary, through the New Drug Funding Program (NDFP), or through the Exceptional Access Program (EAP).

Agreements are intended to provide access to new and existing drugs according to certain conditions, and are based on a number of factors including the CED's recommendations, clinical evidence, therapeutic need,  and cost-effectiveness. Listing agreements may include multiple components:

  • commitment to promote appropriate use;
  • requirement to collect outcomes data;
  • requirement to gather further evidence related to clinical or economic information for future consideration by CED; and
  • cost and utilization considerations.

Flow chart representing the process

Flow chart representing the process

See Also:

For More Information

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