CADTH Pharmaceutical Reviews Update — Issue 24

Canada's Drug Agency Pharmaceutical Reviews Update — Issue 24

See Pharmaceutical Reviews Update – Issue 24 for important news and information regarding the Canada's Drug Agency drug review programs. Highlights from this issue include:

• final Canada's Drug Agency reports to sponsors
• updated expert committee schedules
• timelines for issuing final recommendations
• clarifications regarding reconsideration process
• new application requirement: status in other jurisdictions.

Canada's Drug Agency Program Updates

1. Updated Expert Committee Schedules

Effective September 2021, Canada's Drug Agency will be shifting the target date for Canadian Drug Expert Committee (CDEC) meetings from the third to the fourth Wednesday of each month. This change is being introduced to optimize the workflow for Canada's Drug Agency staff and minimize overlap between the expert committee meetings for oncology and non-oncology drugs. These changes are reflected in updated expert committee schedules on the Canada's Drug Agency website.

2. Timelines for Issuing Final Recommendations

Effective for all applications that were reviewed at the May 2021 expert committee meetings, Canada's Drug Agency has revised the timelines for issuing the final recommendations to the sponsor and drug programs for drugs that are not undergoing further review through the reconsideration process. Final recommendations for drugs that are not undergoing reconsideration will now be issued 8 to 10 business days after the end of the stakeholder feedback period rather than 5 to 7 business days (i.e., an overall increase of 3 business days to current distribution schedules). This revision is being done for two reasons:

• Provide additional time for Canada's Drug Agency, the sponsor, and the drug programs to see if requests for reconsideration can be resolved through editorial revisions to the recommendation document. This can help avoid the greater extensions to the overall review timelines that would occur because of the reconsideration process.
• Harmonize the timelines for finalizing recommendations for drugs not undergoing reconsideration (currently 5 to 7 business days after the end of the feedback period) with those that undergo reconsideration (currently 8 to 10 business days after the expert committee meeting).

3. Final Canada's Drug Agency Reports to Sponsors

In response to feedback, Canada's Drug Agency will now provide sponsors with a copy of the clinical and economic reports that are sent to the expert committees for their deliberations. Canada's Drug Agency will send these reports to the sponsor at the same time they currently receive the Canada's Drug Agency responses to the sponsor’s comments on the draft report. This change is effective for all applications targeting the following meetings:

• July 15, 2021 pERC meeting
• July 21, 2021 CDEC meeting

For all other applications currently being reviewed through the Procedures for Canada's Drug Agency Reimbursement Reviews, the sponsors will be provided with a copy of the review reports if notified that the file is undergoing a request for reconsideration or at the time.

4. Clarification Regarding Reconsideration Process

4.1 Reconsideration Meetings

Canada's Drug Agency has received inquiries from sponsors regarding the reconsideration meetings. The purpose of the reconsideration teleconference is to provide the sponsor with an opportunity to elaborate on the issues that they have raised when a request for reconsideration is filed by the sponsor with Canada's Drug Agency. These meetings are not offered for a situation where the request for reconsideration has been filed by the participating drug programs. In such cases, Canada's Drug Agency provides the complete written request for reconsideration to the sponsor and provides an opportunity for direct input and commentary on the request. Canada's Drug Agency cannot facilitate a meeting between the sponsor and representatives of the public drug programs. The Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to provide additional clarity regarding this aspect of the process.

4.2 Commentary on Reconsideration Requests Filed By The Drug Programs

Canada's Drug Agency provides an opportunity for sponsors to comment on requests for reconsideration that are filed by the public drug programs. To streamline this process, Canada's Drug Agency has added an additional section to the request for reconsideration template for sponsors to provide their commentary on requests for reconsideration that are filed by the drug programs. The instructions for this template and the Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to provide additional guidance on this part of the reconsideration process.

4.3 Resolution of Requests Through Editorial Revisions

To minimize the overall review timelines, Canada's Drug Agency aims to resolve requests for reconsideration in the most efficient manner. In some cases, requests for reconsideration may be resolved through editorial revisions to the recommendation document. In such cases, Canada's Drug Agency may contact the sponsor and/or drug programs for confirmation that the editorial revisions are acceptable, and that the reconsideration process will not be required to resolve the issues.

5. New Application Requirement: Status in Other Jurisdictions

Canada's Drug Agency often receives updates from sponsors regarding the status of the drug under review in other jurisdictions, including: Regulatory agencies (e.g., United States Food and Drug Administration, European Medicines Agency, and the Australian Therapeutic Goods Administration) and health technology assessment agencies (e.g., National Institute for Health and Care Excellence [NICE], Scottish Medicines Consortium [SMC], and the Australia Pharmaceutical Benefits Committee [PBAC]).

Canada's Drug Agency appreciates these updates from sponsors and would like to standardize the process and timing for collecting this information. Canada's Drug Agency will require sponsors to complete a brief summary table with the status of the drug under review for selected regulatory and health technology assessment agencies. This revision to the process will eliminate the need for sponsors to provide multiple updates throughout the review process and ensure fairness for all sponsors with respect to the information provided to Canada's Drug Agency.

Sponsors will be required to provide this information with the initial application package and subsequently provide an update when submitting comments on the draft Canada's Drug Agency reports. This process will be implemented in two phases:

• For all applications targeting the September 2021 expert committee meetings, sponsors will be required to provide the completed template at the time of filing their comments on the draft reports.
• For all applications received on or after August 3, 2021, sponsors will be required to provide the completed template at the time of filing the application package and provide an updated copy when filing their comments on the draft reports.