CDR Update - Issue 1
Transition to the Permanent Common Drug Review
The Common Drug Review
The Common Drug Review (CDR) is a single process for reviewing new drugs and providing listing recommendations to participating federal, provincial and territorial (F/P/T) drug benefit plans in Canada. All jurisdictions are participating except Quebec. The CDR consists of :
- A critical appraisal of best available clinical and pharmacoeconomic evidence
- A listing recommendation made by the Canadian Expert Drug Advisory Committee (CEDAC)
The drug plans continue to make the decisions regarding the listing of drugs in their jurisdictions.
Current funding enables the CDR Directorate to conduct reviews of new chemical entities and new combination products. Submissions for products other than new chemical entities or new combination products should be made directly to individual drug plans.
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) will deliver the CDR to participating drug plans. CCOHTA has set up a new operating unit, the CDR Directorate, to deliver the CDR.
Objectives of the Common Drug Review
The objectives of the Common Drug Review are to:
- Provide a consistent and rigorous approach to drug reviews and an evidence-based listing recommendation
- Reduce the duplication of effort by the participating drug plans
- Maximize the use of resources and expertise
- Provide equal access to the same high level of evidence and expert advice by the participating drug plans
Interim Common Drug Review
Since March 2002, new chemical entities and new combination products have been reviewed through an Interim Common Drug Review process. The interim process uses a distributive model steered by the CDRC and coordinated by a secretariat housed at CCOHTA. Manufacturers make submissions directly to individual drug plans. One drug plan conducts the clinical or the pharmacoeconomic review and shares the review with all participating drug plans. The Interim CDR does not provide a common listing recommendation. Reviews for 22 drugs were completed and shared with participating plans between March 2002 and April 2003. The Interim CDR will continue until the permanent CDR is implemented.
For information about the status of a review under the Interim CDR, manufacturers should contact Elaine MacPhail, Senior Pharmacist, CDR Directorate [Phone: (613) 226-2553 ext. 230; e-mail: elainem@ccohta.ca].
Transition to the Permanent Common Drug Review
Substantial progress has been made towards the implementation of the permanent CDR. Work already completed or nearing completion includes:
- CDR Directorate staffing
- Developing processes and procedures, evaluation methods and a communication plan.
The transition to the permanent CDR will be finalized over the next 4 months. Key steps in this process include:
- Finalizing the CDR procedure documents (targeted for the end of May 2003).
- Conducting workshops with industry on making submissions to the CDR Directorate
(being planned for June, 2003) - Appointing the Canadian Expert Drug Advisory Committee (CEDAC) members
(Nominations closed May 14, 2003; appointments targeted for June 2003) - Accepting submissions from manufacturers directly to the CDR Directorate (rather than to all plans) for new chemical entities and new combination products
(targeted for summer 2003) - Holding the initial CEDAC meetings (orientation meeting targeted for summer 2003; meeting to review first submissions targeted for fall 2003)
These are target dates only and are subject to change. The CDR Directorate will provide as much notice as possible as different phases of the CDR are implemented.
Transparency and Communications
Transparency and communications are important components of the CDR program. The CDR Directorate is committed to dialogue and information sharing with industry and other stakeholders. The program's communication objectives include:
Ensuring the CDR's role, objectives and processes are clearly understood
- Ensuring a smooth transition to the permanent CDR
- Providing updates on program and policy changes.
- The primary communications vehicles will be the CCOHTA's web site and electronic publications.
The CDR Directorate consulted with the pharmaceutical industry on January 14, 2003 and with public stakeholders on March 4, 2003. The issues and suggestions brought forward by these stakeholders were thoroughly considered in developing CDR processes and procedures.
Frequently Asked Questions
Frequently asked questions (FAQs) about the CDR will be posted on CCOHTA's web site. The FAQs will be updated on a regular basis.
Who's Who at the CDR Directorate
Director: Barb Shea, BSP
Senior Pharmacist: Elaine MacPhail, BScPharm, MHP
Pharmacist: Terri O'Grady, BScPharm, PhD
Analyst: Mike Gaucher, BSP, MBA
Scientific Advisor: Vijay Shukla, BPharm, PhD
Executive Assistant: Cheryl Fawcett
CDR Update is published by the CDR Directorate,
CCOHTA, 600-865 Carling Avenue, Ottawa, ON K1S 5S8.
Telephone: 613-226-2553 Fax: 613-226-5392
Website: www.ccohta.ca