CADTH Pharmaceutical Reviews Update — Issue 23

Update for Patients and Communities

In introducing its aligned drug review process, Canada's Drug Agency also announced a new opportunity for patient participation by giving groups a chance to comment on draft recommendations. Following expert committee deliberations, a draft recommendation for each drug under review is shared on the Canada's Drug Agency website, at which point patient and clinician groups have 10 business days to submit feedback.

If you are a patient group that would like to comment on a draft recommendation, Canada's Drug Agency has step-by-step instructions to guide you through the process using the Canada's Drug Agency template. We encourage groups to focus their efforts on the questions that are most relevant and important to you. We also invite you to write your comments in point form so that you can make the best use of the 3-page limit. The feedback you share with us can help improve the clarity of the text in the recommendation. And if the sponsor and drug programs file a request for reconsideration, your feedback will be considered by the expert committee in its deliberations.

The list of feedback opportunities is available on the Canada's Drug Agency Open Calls page. Announcements are also sent via the Canada's Drug Agency Weekly Update. If you would like to subscribe to be notified of open calls for feedback, you can do so here.

If you are interested in contributing feedback, the Canada's Drug Agency Guidance for Providing Patient Input explains the type of information that is helpful to Canada's Drug Agency and what we expect patient groups can achieve within the 10-day window to submit feedback. If you have questions about the process, please contact [email protected] or call Canada's Drug Agency at 1-866-988-1444.

Canada's Drug Agency Program Updates

1. Important Reminder: New Reconsideration Process

Sponsors are reminded that Canada's Drug Agency has implemented a new reconsideration process as part of the initiative to align and improve Canada's Drug Agency reimbursement review processes. Sponsors who wish to file a request for reconsideration must complete a reconsideration request template and send it to Canada's Drug Agency as a Word document using the Canada's Drug Agency Collaborative Workspaces. The request must be received within the 10-day period for stakeholder feedback. No extensions will be granted to the timelines for filing a request for reconsideration. This new process is effective for applications received after October 26, 2020 for non-oncology drugs or October 20, 2020 for oncology drugs (i.e., those targeting the April 2021 expert committee meetings). Complete details regarding the reconsideration process are available in the Procedures for Canada's Drug Agency Reimbursement Reviews.

2. Updated Economic Requirements for Cost-Minimization Analyses

The Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to provide additional guidance on the application requirements for sponsors who are planning to file a cost-minimization analysis with Canada's Drug Agency.

3. Timing of Revised Canada's Drug Agency Pharmacoeconomic Requirements (Transparent Trace)

Canada's Drug Agency is clarifying that the requirement for sponsors to provide a transparent trace within the economic and budget impact models that is not hard-coded by Visual Basic for Applications (VBA) is effective for applications received on or after June 11, 2021, for cancer drugs and June 18, 2021, for non-cancer drugs.

4. Update to Procedural Review Process

The Procedures for Canada's Drug Agency Reimbursement Reviews have been revised regarding the process for notifying the sponsor and drug programs when a request for a procedural review has been made by someone other than the sponsor. Canada's Drug Agency will now notify the sponsor and the participating drug programs if the request for a procedural review has been accepted and not when the request has been received (as was previously communicated). This change has been undertaken to reduce the administrative burden for Canada's Drug Agency, the sponsor, and the participating drug programs.

5. Clarification Regarding Calls for Patient and Clinician Group Input

The Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to clarify that the 35 business day period that the calls for patient group input and clinician group input are open begins on the date that stakeholders are notified in the Canada's Drug Agency Weekly Summary; the period does not begin on the date that the pending application has been added to the Open Calls for Patient and Clinician Input page. Pending applications are added to the open calls for patient group and clinician group input web page 20 business days prior to the anticipated date of receipt. To ensure that all stakeholders have at least 35 business days to prepare their input, Canada's Drug Agency uses the date of communication in the Canada's Drug Agency Weekly Summary as the starting point.

6. Informing Sponsors About the Evidence Included in the Canada's Drug Agency Clinical Report

​The list is provided to the sponsor for information only to assist in preparing the appropriate resources for reviewing and providing informed commentary on the draft Canada's Drug Agency reports.

• systematic review (pivotal and protocol selected studies)
• indirect evidence
• other relevant evidence (e.g., long-term extension studies or other studies that may address important gaps in the randomized controlled trial evidence).

The list is provided to the sponsor for information only to assist in preparing the appropriate resources for reviewing and providing informed commentary on the draft Canada's Drug Agency reports.

7. Revised Checklists for Application Requirements

Canada's Drug Agency has consolidated many of the checklists in the Procedures for Canada's Drug Agency Reimbursement Reviews to reduce duplication in the document. The checklists are now arranged in the following format:

1. Clinical and administrative requirements
A. Submission for a standard review or a cell and gene therapy review
B. Submission for a tailored review
C. Resubmission
D. Reassessment

2. Pharmacoeconomic requirements

3. Budget impact requirements

8. Timelines for Posting Final Recommendations

The Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to clarify the timelines for posting the final recommendation documents on the Canada's Drug Agency website. To streamline the publication process and to ensure that Canada's Drug Agency recommendations are compliant with the Accessibility for Ontarians with Disabilities Act (AODA), Canada's Drug Agency will copy-edit and format the final recommendations after any applicable redactions have been validated by the sponsor. There are no changes to the timelines for issuing the final recommendations to the sponsor or the participating drug programs. The target timelines in the Procedures for Canada's Drug Agency Reimbursement Reviews have been updated to include an additional 6 business days as part of the final publication process.

Canada's Drug Agency remains committed to increasing transparency in its review processes and will continue to engage with industry on opportunities to reduce the amount of redactions in its reports.