Updates to the Therapeutic Review Framework


In January 2012 CADTH outlined our process for undertaking Therapeutic Reviews in a Therapeutic Review Framework. Today we have updated this framework to clarify the timing and scope of these reviews, as well as the type of evidence that is considered.

These changes are outlined in more detail below.

  1. Revised Therapeutic Review Framework: Definition

CADTH has revised the definition of a Therapeutic Review to clarify the timing of Therapeutic Review projects. Within the 2012 CADTH Therapeutic Review Framework, it is stated that Therapeutic Reviews are prepared to coincide with a CADTH Common Drug Review (CDR) of a formulary submission. This has recently been revised to reflect the possibility that CADTH Therapeutic Reviews may not always coincide with a CDR submission.

To reflect this update, CADTH has revised the Therapeutic Review Framework with the following definition:

A Therapeutic Review is an evidence-based review of publicly available sources regarding a therapeutic category of drugs (e.g., antihypertensive agents) or a class of drugs (e.g., angiotensin-converting enzyme inhibitors [ACEIs]) in order to support drug listing and policy decisions and encourage the optimization of drug therapy.

The optimization of drug therapy involves ensuring that the right drugs are prescribed and used appropriately to improve or maintain optimal health. This requires balancing maximized benefits with minimized risks for people’s health based upon best quality evidence, taking into account the options, costs, available resources, and societal context.

An important characteristic of a Therapeutic Review is that it may inform CADTH Common Drug Review (CDR) submission reviews and associated Canadian Drug Expert Committee (CDEC) listing recommendations, which in turn advise drug plan decisions. However, CADTH Therapeutic Reviews may not always coincide with a CDR submission..

  • Publicly funded drug plans evaluate and consider the addition of new drugs to their formularies. They do this based on favourable efficacy, safety, and cost-effectiveness analyses as reviewed by CADTH’s CDR program. However, decisions are also made in the context of existing coverage policies of therapeutically related drugs; for this reason, Therapeutic Reviews may be conducted. The final output of a Therapeutic Review project includes:
  • science report (clinical and economic review)
    • patient input received is incorporated into the clinical review
  • recommendation(s) or advice from CDEC (based upon evidence contained within the science report)

Please direct any questions to requests@cadth.ca.

  1. Revised Therapeutic Review Framework: Scope to Include Drugs with Evidence-Expanded Use

Effective immediately, CADTH has revised the scope of a Therapeutic Review to allow for the inclusion of drugs with evidence-based expanded use (i.e., for a clinical indication not included in an approved Health Canada product monograph), provided that sufficient clinical evidence on efficacy and safety is available.

CADTH has revised the Therapeutic Review Framework with the following statement:

Technologies typically chosen for a Therapeutic Review are related to emerging drugs, or a drug with a new indication, or Pre-Notice of Compliance that is (or is expected to be) submitted to CDR for review. In exceptional circumstances, the project scope may include drugs with evidence-based expanded use (i.e., for a clinical indication for which a pharmaceutical manufacturer has not applied to Health Canada and that is not included in an approved Health Canada product monograph), provided that sufficient clinical evidence on efficiency and safety is available.

Please direct any questions to requests@cadth.ca.

  1. Clarification of Therapeutic Review Framework: Only Publicly Available Evidence Included

As outlined in the revised definition, a Therapeutic Review is an evidence-based review of publicly available sources regarding a therapeutic category of drugs (e.g., antihypertensive agents) or a class of drugs (e.g., angiotensin-converting enzyme inhibitors [ACEIs]) in order to support drug listing and policy decisions and encourage the optimization of drug therapy.

The primary evidence evaluated for possible inclusion in a Therapeutic Review is from the public domain. Sources of evidence are described as follows:

  • Published literature is identified by searching major biomedical bibliographic databases using an internally peer-reviewed search strategy. Bi-weekly search updates are run for the duration of the review.
  • Grey literature (literature that is not commercially published) is identified by searching relevant sections of the CADTH Grey Matters checklist (http://www.cadth.ca/resources/grey-matters). Internet search engines are used to identify additional web-based materials.
  • A clinical expert is engaged and given the opportunity to suggest evidence to be reviewed.
  • Manufacturers (industry) impacted by the review are contacted to confirm available evidence.
  • Authors may hand search the references of included studies.

Note: Stakeholders are given the option of identifying and providing unpublished data for consideration in the Therapeutic Review on the condition that, if used, it will be included in publicly available reports and documents related to the Therapeutic Review.

CADTH will notify interested parties of stakeholder feedback opportunities by posting a notice to the Calls for Feedback page and issuing an email to subscribers of the CADTH E-Alert service. Instructions on providing feedback are included with every notification.

If you have any questions about the feedback process, please email requests@cadth.ca.

We are currently in the process of incorporating these revisions into the Therapeutic Review Framework document and an updated version will be posted later this spring.