CDR Process

Origins

The Canadian Agency forDrugs 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 toevolve 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 ofthe process:

• A drug manufacturer, a drug plan, or the Advisory Committee on Pharmaceuticals files a submission for a new drug to the CDR.
• A call for patient input is posted on the Patient Input page of the CADTH website.
• A CDR review team is established for the drug submission.
  • Typically, review teams consist of clinical reviewers, pharmacoeconomic reviewers, clinical experts, information specialists, methodologists, project managers, submission coordinators, administrative support, and peer reviewers (who are independent of the team).
  • 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 evaluation are prepared by the review team.
  • The reviews are based on the drug submission, information retrieved through independent literature searches, and patient group input — 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), which is a CADTH advisory body.
• 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 on the CADTH website.