CDR Update — Issue 64

December 18, 2009

In This Issue

Fixed Dose Combinations — Consultation:  Due January 27, 2010

The Canadian Agency for Drugs and Technologies in Health (CADTH) is inviting feedback on a proposed tailored approach by the Common Drug Review (CDR) program for reviews of fixed dose combination products. This approach would apply only to fixed dose combinations containing two or more drugs that are already funded by CDR-participating drug plans. These combination products may contain funded non-prescription drugs, but at least one component must be a prescription drug. All other fixed dose combination products will follow the regular review process and must meet regular CDR submission requirements.

The main characteristics of the tailored (streamlined) fixed dose combination products review process are as follows:

  • The manufacturer will be required to complete a template with required information and references. The categories of information include:
    • rationale for the combination (pharmacologic and therapeutic)
    • bioequivalence evidence
    • place in therapy
    • harms information
    • pharmacoeconomic evaluation.
  • CDR reviewers will validate and comment on the information provided by the manufacturer — CDR reviewers will not be conducting systematic reviews of the submitted information.
  • The Canadian Expert Drug Advisory Committee (CEDAC) will make a listing recommendation based on the submitted information and the CDR reviewers’ assessment or comments about it. The regular steps for issuing the CEDAC recommendation will be followed.

This invitation for consultation includes:

  • a flowchart to assist in determining whether a fixed dose combination product is eligible for a tailored (streamlined) review
  • a proposed template outlining the type of information that is required
  • the changes to the manufacturers’ submission requirements for this type of submission.

Please email your feedback by January 27, 2010, to cdrfeedback@cadth.ca. Your comments will be considered as we finalize the tailored review process for fixed dose combination products.