CADTH Pharmaceutical Reviews Update — Issue 18

Canada's Drug Agency Program Updates

1. Communications for Canada's Drug Agency Drug Reimbursement Reviews

1.1 New Consolidated Web Pages

Canada's Drug Agency is pleased to launch its new consolidated web pages for all Canada's Drug Agency drug reimbursement review processes. These pages consolidate the existing web pages that were used for the individual Canada's Drug Agency drug review processes (i.e., Common Drug Review, pan-Canadian Oncology Drug Review, and Interim Plasma Protein Product Review Process). The key changes include updated and consolidated web pages for the following:

• A summary table for all drug reimbursement reviews
• information on patient input and clinician input
• opportunities for stakeholder input and feedback
• procedures and application templates
• a list of participating drug programs
• expert committee meeting schedules.

1.2 New Weekly Update

Canada's Drug Agency has been working to consolidate the communications for our drug reimbursement review process. We are pleased to announce our first new weekly email communication, which will be issued next Thursday, November 5, 2020. We anticipate these updates will be issued every Thursday, and they will include the following information:

• open calls for patient and clinician group input
• open calls for stakeholder feedback on draft recommendations and provisional algorithms
• notice of final recommendations and provisional algorithms
• pharmaceutical review program updates.

2. Clinician Engagement

2.1 Reminder: Conflict of Interest Declarations

Canada's Drug Agency has recently encountered several situations where clinicians and clinician groups have not completed conflict of interest declarations when submitting input to Canada's Drug Agency. This includes forms that have been completed incorrectly or not completed at all. In each instance, Canada's Drug Agency has had to repeatedly contact individuals and groups to obtain the necessary declaration. Clinician input is an important part of our drug reimbursement review process; however, Canada's Drug Agency would like to remind all stakeholders that we cannot accept input that is submitted without the required conflict of interest disclosures.

2.2 Process Change: Validation of Canada's Drug Agency Summary of Clinician Group Input

CADTH’s recent experience with conflict of interest declarations and feedback from clinical associations has demonstrated that both Canada's Drug Agency and the clinical associations are having challenges reaching those members of the clinical community who have contributed input into the Canada's Drug Agency oncology drug reimbursement review process. As such, the Procedures for Canada's Drug Agency Drug Reimbursement Reviews have been revised, and clinician groups will no longer be asked to review and validate the summary of input that is prepared by Canada's Drug Agency. This change is being made proactively by Canada's Drug Agency to:

• avoid placing additional burden on the clinical community at this challenging time
• reduce the risk of process delays that may occur as a result of late responses
• reduce the administrative burden on Canada's Drug Agency and clinical associations by limiting the need to engage in extensive follow-up correspondence with participants who have not responded.

We anticipate this process revision will be in place for the duration of the COVID-19 pandemic. We will revisit this process change in the future.

3. Therapeutic Review Framework

Canada's Drug Agency has made minor editorial adjustments to the Therapeutic Review Framework to reflect the alignment and consolidation of the Canada's Drug Agency drug reimbursement review processes.

4. Application Fees

Canada's Drug Agency previously announced a change to the application fees for the pCODR process. A schedule D fee was to apply to requests for reconsideration filed by industry sponsors after the October 2020 meeting of the pCODR Expert Review Committee. A decision has been made to postpone the introduction of the schedule D fee for pCODR reconsiderations until the April 2021 expert committee meetings.