On December 7, 2009 the Canadian Agency for Drugs and Technologies in Health (CADTH) announced a pilot project for conducting a concurrent review of a CDR submission(s) and a therapeutic review of the same drug class or category as the CDR submission.

What is a therapeutic review?

A therapeutic review is a review of the most recent evidence available in the public domain regarding a single drug, a drug class, or a drug category. Generally, these are drugs, drug classes, or drug categories that have been available in the marketplace for some time. The scope and depth of the reviews will be determined by the jurisdictions and CADTH. The final outputs of the CADTH therapeutic reviews will include either recommendations, advice, or a report and conclusions.

Why is CADTH undertaking a therapeutic review pilot project?

The need for therapeutic reviews at the time that formulary decisions are being made has been identified as a need by participating drug plans and expert advisory committees for some time. Therapeutic reviews are seen as an important tool in the overall recommendation and policy decision-making process. In addition to making listing decisions based on efficacy, safety, and cost-effectiveness analyses of available information, drug plans also consider the existing coverage policies of therapeutically related drugs. To this end, a working group comprising members from the Advisory Committee on Pharmaceuticals, the COMPUS Advisory Committee, and CADTH staff has developed a framework for therapeutic reviews conducted concurrently with formulary submissions. The purpose of the pilot project is to test and to make enhancements to the framework. 

Will affected manufacturers have a role in the therapeutic review pilot project?

Manufacturers that have products included in the therapeutic review pilot project will be apprised directly and will be invited to provide input and comments during specific phases of the therapeutic review process.

What are the next steps in the therapeutic review pilot project? 

• A more detailed description of the therapeutic review pilot project will be posted in the near future.
• On completion, the therapeutic review pilot project will be evaluated. The findings from the evaluation will be used to make changes and improvements to the requirements and process for conducting therapeutic reviews.

• The revised process for conducting therapeutic reviews will be posted for stakeholder feedback (after the pilot project is completed), and relevant feedback will be used to further enhance the process.

We can be contacted at cadthfeedback@cadth.ca.