CDR Update - Issue 31

Revised Format for CEDAC Recommendations

The format of the recommendations made by the Canadian Expert Drug Advisory Committee (CEDAC) has been revised slightly to increase the clarity of the reasons for recommendation.

In each CEDAC Recommendations document, the key “Reasons for the Recommendation” will be provided under one heading. A new section entitled “Summary of Committee Considerations” will be incorporated to briefly summarize other information reviewed by the committee.

A “Background” section will also be added to each recommendation to briefly describe CEDAC’s role in providing listing recommendations to public drug plans.

The changes to the recommendations format will go into effect for new submissions considered by the committee at the October 18, 2006 meeting.

Updated CEDAC Terms of Reference

The Terms of Reference for CEDAC were recently amended to permit a change to a previous recommendation by the committee in response to a request for advice from the drug plans that participate in CDR.

The change will enable CEDAC to review a previous recommendation based on new information that would not meet the criteria for a resubmission to CDR. For example, new information on comparator drugs could influence the place in therapy of a drug previously considered by the committee. This change in the Terms of Reference will provide a mechanism for reviewing and updating CEDAC recommendations to ensure their continued relevance.

The Procedure for the Common Drug Review allows the Advisory Committee on Pharmaceuticals and drug plans to submit a request for advice to CDR and CEDAC. Responses to the request for advice are developed by the CDR Directorate, and provided to CEDAC for consideration.

Guidance for Filing Submissions to CDR

Reminder regarding disease prevalence information
Manufacturers and consultants filing submissions to the Common Drug Review are reminded to provide disease prevalence and incidence information as a Category 1 requirement, as well as to include this information in the budget impact analyses. The information is used by the clinical reviewers early in the review process, but the budget impact analyses are often submitted later as Category 2 requirements.

For more details, please see the economic and epidemiologic information requirements in the CDR Submission Guidelines for Manufacturers, section 4.2.1 Category 1 Requirements, item f, and section 4.2.2 Category 2 Requirements, item b.

Clarification of bibliography requirements
The bibliography of submitted studies (required under the CDR Submission Guidelines for Manufacturers, section 4.2.1 Category 1 Requirements, item j) is to be a listing of the studies (both published and unpublished) that the manufacturer has included in the CDR submission.

A second bibliography is required for articles included for other reasons such as supporting the validity of outcome measures, another systematic review, etc. Please note that the search strategy used to identify published studies is required, but the full search results are not required.

CDR Update is an e-bulletin published by the Canadian Agency for Drugs and Technologies in Health (CADTH) to inform stakeholders and other interested parties of the initiatives and activities of the Common Drug Review (CDR) program.

CADTH, formerly known as the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), is a significant contributor to Canada’s health care system. Federal, provincial and territorial health care decision makers rely on CADTH to provide them with credible, impartial advice and evidence-based information about the effectiveness of drugs and other health technologies.

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