CDR Process

Consultation - CDR Transparency Initiatives

Origins

The Canadian Agency for Drugs and Technologies in Health developed the Common Drug Review (CDR) process, in consultation with the drug plans that participate in the program, the pharmaceutical industry, and the public.

The process continues to evolve as a result of ongoing communications with these and other stakeholders.

For detailed information

The Procedure for Common Drug Review describes, in detail, the CDR process for reviewing drugs and providing formulary listing recommendations to the public drug benefit plans in Canada (except Québec).

Summaries of Process

The following points, or the Common Drug Review process flowchart, provide summaries of the process.

• A drug manufacturer, a drug plan, or the Advisory Committee on Pharmaceuticals files a submission for a drug to the CDR.
• A CDR review team is established for the drug submission.
  • Typically, review teams consist of clinical reviewers, pharmacoeconomic reviewers, a clinical specialist, an information specialist, the CDR Manager of Drug Reviews, a project advisor, and a project manager.
  • Reviewers must abide by the Conflict of Interest Guidelines for the Common Drug Review.
• A systematic review of the clinical evidence, and a critique of the pharmacoeconomic data are prepared by the review team.

• The reviews are based on the drug submission, plus information retrieved through independent literature searches, to ensure that all available evidence is considered.
• Guidelines and templates are used in preparing the reviews to ensure a consistent, rigorous, and high quality approach.

• CDR edits and assesses the reviews for quality.
• Reviews are sent to the manufacturer for comment.
• Reviewers prepare a reply to the manufacturer’s comments on the reviews.
• A dossier is prepared for the Canadian Expert Drug Advisory Committee (CEDAC).
• CEDAC meets to consider the submission.
  • Deliberations are based on the CEDAC dossier, and may also include input from other experts or the CDR review team.
• The initial CEDAC formulary listing recommendation, and the reasons for the recommendation, are sent to the manufacturer and the drug plans in confidence.
• During the embargo period, the drug plans may request clarification of the recommendation; and based on specified criteria, the manufacturer may request that CEDAC reconsider the drug.
  • If the drug plans request clarification, it is provided.
  • If the manufacturer requests and is granted a reconsideration, CEDAC reviews the submission at a subsequent meeting.
• The final recommendation and reasons for the recommendation are sent to the manufacturer and drug plans, and are then released publicly.

Guidelines and Templates for reviewers:

• Common Drug Review Clinical Review Report Template
• Common Drug Review Pharmacoeconomic Review Report Template
• General Guidelines for Reviewers Common Drug Review Process
• Guidelines for Clinical Reviewers Common Drug Review Process