CDR Update - Issue 39

September 10, 2007

In This Issue

Common Drug Review Expansion - Clarifications

The following information answers some common queries we have received about the Common Drug Review (CDR) expansion to reviews of drugs with new indications.

Who initiates CDR reviews for drugs with new indications?
As with other submissions to the CDR, they will be initiated primarily by manufacturers, while participating drug plans will also continue to have the option of initiating a submission.

How do manufacturers determine whether they submit to CDR or to individual drug plans?
The criteria describing which drugs with new indications are eligible for submission are outlined in the CDR Submission Guidelines for Manufacturers. When there are questions about whether a particular product meets these criteria, the manufacturer is invited to contact CDR for direction at the earliest opportunity. If required, CDR will consult participating drug plans for further direction. CDR will then communicate to the manufacturer whether the submission should be made to CDR or to the individual drug plans.

What is the CDR process for drugs with new indications?
As described in the Procedure for the Common Drug Review, drugs with new indications follow the same process with the same time frames as other submissions to CDR.

When will CDR start reviewing drugs with new indications?
CDR will begin accepting submissions for drugs with new indications on October 1, 2007.

CDR Consultation Results

Three proposed changes to the Procedure for the Common Drug Review and CDR Submission Guidelines for Manufacturers were posted on the CADTH web site for consultation in July. As a result of the feedback received, minor changes will be made to these two documents and the revised versions will be posted on the web site shortly. The following summarizes the feedback received on the three consultation areas, and any resulting changes to our procedures:

  1. CDR Priority Review Process
    Most responders felt that the proposal relating to Priority Review - to decrease the time for manufacturers’ comments from seven (7) to three (3) days, and to decrease page allotment for comments from six (6) to three (3) pages - would preclude manufacturers from adequately commenting on the CDR reviews, particularly if they need to communicate with global offices.

    Therefore, CDR will amend the Priority Review procedure to give manufacturers the option of providing comments within three (3) days, on a maximum of three (3) pages, with CDR Reviewers preparing replies within three (3) days.

    Shortening the timelines in this way may enable the drug to be placed on an earlier agenda of the Canadian Expert Drug Advisory Committee (CEDAC). In this case, CDR will inform manufacturers who are granted priority review when there is an opportunity to shorten the timelines and be placed on an earlier CEDAC agenda. Manufacturers will be requested to decide at the time priority review is granted whether or not they will exercise the option to reduce the timelines. This will, in turn, enable CDR to adjust the deadlines relating to the drug review.

  2. Health Canada Reviewers’ Reports
    Most of the feedback indicated it was not feasible to make the Health Canada Reviewers’ Report a Category 1 requirement, as it typically takes 30 days to receive the report after the manufacturer has requested it, and this may delay filing a submission to CDR.

    In response, CDR will not make the Health Canada Reviewers’ Report a Category 1 requirement; it will, instead, remain in the “Additional Information” section of the Submission Guidelines.

    However, CDR will revise the Submission Guidelines to indicate that we routinely ask manufacturers to provide the Health Canada Reviewers’ Report. Therefore, manufacturers are encouraged to submit a request for the report to Health Canada as soon as they are aware that a Notice of Compliance will be issued.

  3. Clinical Study Reports
    Responders expressed reluctance to include Clinical Study Reports in searchable CD-format as a Category 1 requirement, primarily given the size of documents and that they may contain preliminary information which may be potentially misleading. Thus, CDR will not make the Clinical Study Reports a Category 1 requirement; we will, instead, add Clinical Study Reports to the “Additional Information” section of the Submission Guidelines.

    As indicated in the consultation document, CDR finds that some submissions do not contain all of the trial data or trial design information required for the review. Requesting this additional information from the manufacturer can add time and/or delays to CDR reviewers’ work. Our experience is that Clinical Study Reports facilitate the retrieval of required information. Therefore, we will continue to explore ways to ensure that submissions contain all of the clinical study information that CDR Reviewers require for their work.

Transparency Initiatives

CDR is committed to increasing the transparency of our processes and the basis of our recommendations - as suggested in the CDR Evaluation and in feedback from stakeholders.

We are currently developing procedures for publishing three additional documents for each drug under review:

  • a plain language version of the CDR Recommendations and Reasons for Recommendation
  • an overview of the CDR clinical and pharmacoeconomic reports
  • a summary of our expert committee’s discussion relating to the drug.

These initiatives will ensure that relevant information is publicly available, while respecting confidential information provided by the drug’s manufacturer.

Within the coming months, draft procedures for the new documents will be posted on the CADTH web site for feedback.

Personnel News

  • We are pleased to announce that Tim Veregin has joined CADTH as Manager of CDR Submissions. He replaces Sandy Pagotto as the primary contact for industry regarding drug submissions to CDR. As announced in Issue 35 of the CDR Update, Sandy is now the Director of CDR. Tim can be reached at TimV@cadth.ca or (613) 226-2553, ext. 550.
  • Changes to the Advisory Committee on Pharmaceuticals (ACP), effective
    July 1, 2007:
    • Chair
      Judy McPhee, Manager, Drug Programs
      Department of Health - Pharmaceutical Services
      Province of Nova Scotia
    • Vice-Chair
      Marilyn Thornton, Director, Pharmaceutical Policy and Programs Branch
      Population Health Division
      Alberta Health and Wellness

  • The CDR Directorate is currently recruiting for:

    • Manager of Drug Reviews
    • Health Economists
    • Clinical Reviewers

    If you are interested in learning more about these career opportunities, visit Careers/Job Listings on the CADTH web site.