About the Common Drug Review
The Common Drug Review (CDR), at the Canadian Agency for Drugs and Technologies in Health (CADTH), is a pan-Canadian process for conducting objective, rigorous reviews of the clinical, cost-effectiveness, and patient evidence for drugs. CDR also provides formulary listing recommendations to Canada’s publicly funded drug plans (except Quebec).
The objectives of CDR are to:
- reduce duplication of reviews by jurisdictions
- provide equal access to timely, evidence-based information and expert advice
- consolidate the submission filing process for pharmaceutical manufacturers.
Drug Plan Decisions
The drug plans make final benefit listing and coverage decisions based on the CADTH recommendations and other factors, such as drug plan mandates, jurisdictional priorities, and financial resources.
The CDR Process
The Procedure for Common Drug Review describes the CDR process in detail.
The Common Drug Review process flow chart illustrates the key steps, which are described briefly, as follows:
- A drug manufacturer, or one or more of the participating drug plans, files a drug submission to CADTH for review.
- A call for patient input is posted on the Patient Input page of the CADTH website and sent to subscribers via an e-alert.
- A review team is established.
- Typically, the team consists of clinical reviewers, economic reviewers, clinical experts, information specialists, methodologists, and administrative support.
- All reviewers must abide by the CADTH Conflict of Interest Guidelines.
- A systematic review of the clinical evidence and a critique of the economic evaluation are prepared by the review team.
- The reviews are based on the drug submission, information retrieved through independent literature searches, and any patient group input received.
- Guidelines and templates are used in preparing the reviews to ensure a consistent, rigorous approach.
- 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 Drug Expert Committee (CDEC), a CADTH advisory body.
- CDEC meets to consider the submission.
- Deliberations are based on the CDEC dossier, and may also include input from other experts or the review team.
- The initial CDEC formulary listing recommendation, and the reasons for the recommendation, are sent to the manufacturer and the drug plans in confidence.
- During the embargo period:
- Drug plans may request clarification of the recommendation.
- The manufacturer may request, based on specified criteria, that CDEC reconsider the drug; if the request is granted, CDEC reconsiders the submission at a subsequent meeting.
- The final recommendation and reasons for the recommendation are released publicly on the CADTH website.