CDR Update — Issue 58

June 22, 2009

In This Issue

Important Clarification of CDR Submission Guidelines — Type of Economic Analysis to be Submitted

Based on assessments of the pharmacoeconomic information included in past submissions to the Common Drug Review (CDR), CDR has determined that the guidelines for providing cost tables as the only type of economic analysis requires clarification (CDR Submission Guidelines for Manufacturers — Appendix 15).

Situations where cost tables may be the only economic analysis provided would be when the submitted drug belongs to an established drug class consisting of multiple agents that have a similar mechanism of action and therapeutic use, and

  • comparative trials show no difference in safety and efficacy or
  • only placebo-controlled trial evidence is available.

In most other situations, the pharmacoeconomic submissions should include a cost-utility analysis or cost-effectiveness analysis. This would include, but is not limited to, submissions for drugs that are new molecules and drugs that have a new (unique) mechanism of action.

Revised CDR Submission Guidelines for Manufacturers are scheduled for posting in July 2009 and will include changes to Appendix 15 — Guidelines for the Type of Economic Analysis to be Submitted.

CADTH thanks industry for its ongoing compliance with the CDR Submission Guidelines for Manufacturers.

Personnel News

Kirsten Garces, Manager of CDR Submissions, will be leaving Ottawa and as a result will be leaving CADTH as of June 19, 2009. CADTH sincerely thanks Kirsten for her contributions to both its Health Technology Assessment (HTA) and CDR programs.

As a result of Kirsten’s departure, industry and those filing submissions should contact Tim Veregin, Manager of Reviews, for all CDR submission-related inquiries. Tim can still be contacted by email at timv@cadth.ca or by telephone at 613-226-2553, ext. 1550.