CDR Update - Issue 46
March 11, 2008
In This Issue
First CDR Transparency Documents Released
In 2007, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced it would further expand the transparency of its Common Drug Review (CDR) program by publishing three additional documents for each drug reviewed by CDR.
CADTH is pleased to announce that the first new documents developed under this transparency initiative were released Friday on its web site for the drug adalimumab (Humira®) for its use in Crohn’s disease. The two new documents include:
a Plain Language Version of the Recommendation and Reasons for Recommendation an Overview of the CDR Clinical and Pharmacoeconomic Reports
A Summary of Discussion, which will summarize the Canadian Expert Drug Advisory Committee (CEDAC) deliberations regarding Humira for the Crohn’s disease indication, is expected to be released later this month.
All three new CDR document types will be posted in the CDR Drug Database on CADTH’s web site — in addition to the Submission Status reports and Recommendations and Reasons for Recommendation that CDR currently posts.
The intent of the new documents is two-fold:
- to enhance understanding of the recommendations by publishing a version that is more easily understood by the general public
- to provide key background information relating to the recommendations that will be of interest to all stakeholders, particularly health care professionals.
Some manufacturers who filed submissions prior to the November 29, 2007 launch of the CDR transparency initiative were invited and agreed to participate in a pilot project to test the CDR Transparency Procedure and timelines. CADTH sincerely thanks these manufacturers for their participation and their comments on the process. Transparency documents for the other drugs in the pilot will be posted as they become available. Full implementation of the new transparency initiative will begin with the drugs considered by CEDAC at its April 16, 2008 meeting.
The CDR Transparency Procedure was developed with input from stakeholders in the fall and added to the Procedure for the Common Drug Review as Appendix 1 in November 2007. As a result of the pilot, some refinements will be made to the CDR Transparency Procedure and posted on CADTH’s web site shortly.
As previously announced, the established targeted time frames for CDR reviews are not impacted by the transparency initiative.
Templates for CDR Review Reports Updated
The templates used by internal and external CDR reviewers in writing their reports have been updated and posted on the CADTH web site:
CDR Clinical Review Report Template
CDR Pharmacoeconomic Review Report Template