CDR Update - Issue 40

In This Issue

• Revisions to the CDR Procedures and Submission Guidelines
• Update to Targeted CEDAC Meeting Dates
• Recent CDR Recommendations
• Employment Opportunities

Revisions to the CDR Procedures and Submission Guidelines

The Procedure for Common Drug Review and CDR Submission Guidelines for Manufacturers documents on the Canadian Agency for Drugs and Technologies in Health (CADTH) web site have now been updated to incorporate the changes announced in CDR Update Issue 39. These changes are the result of feedback received on three items posted on the web for consultation in July. (See CDR Update Issue 38 for consultation announcement.) CADTH would like to thank the people who provided input as part of the consultations. Other minor editorial changes have also been made to the two CDR documents.

Change to Both Documents – New Option to Reduce Priority Review Timeline
At the time CDR notifies a manufacturer that priority review is granted, the manufacturer will also be advised if there is an opportunity to place the submission on an earlier agenda of the Canadian Expert Drug Advisory Committee (CEDAC). This option will be offered in those instances where a reduction of eight business days in the CDR process may allow the submission to be placed on an earlier CEDAC agenda. In order to accomplish this, the manufacturer must agree to provide comments on the CDR review reports within three business days on no more than three pages. The CDR Reviewers’ time to respond to the comments will also be decreased to three business days. The two reduced time frames will shorten the CDR review process by eight business days. (Manufacturers will have four fewer days than usual to comment on the CDR reports, CDR reviewers will have four fewer days to respond to the comments, and the CDR timelines will be adjusted accordingly.)

When notified by CDR that a request for priority review has been granted and the option to reduce the timelines is available, manufacturers will be required to confirm in writing that they wish to exercise the option. (Note that this option applies only to submissions granted priority review status.)

Other Changes to CDR Submission Guidelines
Section 4.2.1 Category 1 Requirements
Item a) the Cover Letter is to include the new indication when submitting a drug with a new indication.

Item d) clarifies that the PDF copy of the product monograph should be in searchable format.

Item e) and Appendix 8 – for published studies included in the submission, copies of related editorial articles and errata published in the same journal are required. The articles and errata should also be included in the tabulated list of published and unpublished studies. In addition, the table is corrected and clarified by inserting a missing heading.

Item f) clarifies that only three copies (in total) of the economic model are required. These three copies should be provided at the time that the Manufacturer is initially filing a Submission. The remaining copies of the Submission provided to CDR and participating drug plans (after the Submission is deemed complete) are NOT required to contain additional copies of the economic model).

Section 4.2.3 Additional Information
Item b) confirms that the Health Canada Reviewers’ Report is not a Category 1 requirement. However, because CDR requests the Health Canada Reviewers’ Report for each submission, Manufacturers are encouraged to request this report from Health Canada as soon as they are assured that their drug will receive a Notice of Compliance (NOC) or Notice of Compliance with conditions (NOC/c) and to forward the report to CDR immediately upon receipt.

Item d) the Clinical Study Report is included as a document that CDR may request from the Manufacturer – if the information in the submission does not contain the trial data or trial design information required by CDR to complete its review.

CDR Pharmacoeconomic Review and BIAs
At the September 11, 2007 teleconference of the Advisory Committee on Pharmaceuticals (ACP), members agreed that CDR pharmacoeconomic reviewers will no longer be required to provide high level commentary on the Budget Impact Analyses (BIAs) submitted to the drug plans. This change recognizes that the drug plans must individually evaluate the impact of adding each drug to their formularies.

This process change does not eliminate the CDR submission requirements for BIAs. CDR continues to have the responsibility to review the submissions on behalf of the participating drug plans to ensure that all of the submission requirements are met.

• Manufacturers must continue to provide BIAs as a Category 1 requirement if requesting Priority Review, based on cost.
• Manufacturers must continue to provide BIAs to CDR as Category 2 requirements, if they are not provided to meet Category 1 requirements. The Category 2 requirements are described in Section 4.2.2 of the CDR Submission Guidelines for Manufacturers. Manufacturers will not need to include BIAs in the five copies of the Submission binders sent to CDR after the Category 2 requirements are deemed complete.

Update to Targeted CEDAC Meeting Dates

The dates on the Filing a Submission page of the CADTH web site have been updated. These dates help manufacturers identify the tentative CEDAC meeting date when a submission would be considered – based on the date the submission is received at CDR, the date it is “deemed complete” and other factors.

Recent CDR Recommendations

The following recommendations were issued through CADTH’s Common Drug Review program from July 1 to September 30, 2007.

Employment Opportunities

The CDR Directorate is currently recruiting for:

• Manager of Drug Reviews

• Clinical Reviewers

• Project Manager