Pharmaceutical Reviews Update — Issue 47

Program Updates

1. Procedures for Provisional Funding Algorithms

Provisional Funding Algorithms are a tool to support the implementation of an expert committee recommendation. Following our recent consultation and in keeping with our commitment to continuous process improvement, we are pleased to share the final revised procedures for Provisional Funding Algorithms. These procedures are incorporated into the latest version of our Procedures for Reimbursement Reviews.

During the consultation, we received 14 responses from the pharmaceutical industry, patient and clinician groups, public drug programs, and cancer agencies. We considered all submissions and incorporated suggestions where feasible; suggestions that will require internal feasibility assessment, substantive changes to the review process, or additional dialogue will be addressed in the future.

Based on feedback for greater clarity on the differences between rapid versus panel algorithms, clinical expert selection, and details related to the panel discussion (e.g., discussion guide questions, dissenting opinions), more information has been added to the final Provisional Funding Algorithms procedures. In addition, the feedback period has increased from 5 to 7 days to provide more opportunities for feedback while balancing the timeliness of the final report.

We are aiming to implement the new procedures in September 2024, which will impact applications received on or after September 3, 2024 (i.e., targeting the February expert committee meetings). Between June and July 2024, relevant templates and documents will be revised and posted to our website. If you have any questions related to the Provisional Funding Algorithms, please contact us at [email protected].

2. Improving Our Assessments of Drugs With Companion Diagnostic Tests

As part of our ongoing initiative to improve and modernize our reimbursement review program, Canada’s Drug Agency is introducing the first phase of process improvements related to companion diagnostics.

A companion diagnostic is a class of medical device used alongside a drug that is essential for the safe and effective use of the corresponding drug or biologic product. These tests can detect biomarkers that may predict a more favourable response to a particular therapy and can be used to help tailor individualized treatment.

Currently, a drug sponsor must include clinical and economic considerations related to companion diagnostics in their applicable reimbursement review submission. To date, the review process has included an evaluation of the clinical utility of the diagnostic test(s), and the evidence has been presented in a clinical review report appendix.

The improvements we are introducing enhance this process and are effective immediately. They include:

• Improved presubmission phase forms: We updated the presubmission briefing template and advance notification templates so we can gather additional information about new drugs that may have implications for diagnostic testing resources and/or impacts on other aspects of the health care system.
• Improved report structure: We will now give our review of companion diagnostic tests more prominence by producing a separate Testing Procedure Assessment Report for drugs or drug regimens that impact diagnostic testing resources rather than embedding this information in a clinical review report appendix.  
• Expanded opportunity for comments: We updated the Sponsor Comments on Draft Reports template so that drug sponsors with applications that have a companion diagnostic have more space to comment specifically on the draft Testing Procedure Assessment Report.  
• A dedicated testing procedures team: A newly formed team focused on precision medicine within our Medical Devices and Clinical Interventions portfolio will conduct reviews of companion diagnostics.

Read the announcement on our website. 

3. Budget Impact Analysis Tool

We have published our budget impact analysis (BIA) tool.

During our consultation earlier this year we received feedback from more than 22 unique groups, including industry, consultants, and public sector organizations. We have considered the feedback provided and, where feasible, made improvements.  

BIAs help decision-makers in publicly funded drug plans understand the potential financial impact and affordability reimbursing new drugs. Our tool gives drug sponsors a structured series of inputs that will help them derive the budget impact of adding a new therapy to existing treatments and/or to the management of a condition. Please note that this tool may help inform the development of BIAs, but drug sponsors are not required to use it in their submissions.

This tool may be updated over time as new methods evolve. You can send questions about this tool to [email protected].

4. Updated Expert Committee Schedules

The schedules for the Canadian Drug Expert Committee (CDEC) and the pCODR Expert Review Committee (pERC) have been updated until the December 2025 meetings. This schedule is updated regularly to allow sponsors to plan for upcoming submissions.

5. Updated Schedule for Presubmission, Pipeline, and Reconsideration Meeting Dates

We have updated the schedule for presubmission, pipeline, and reconsideration meeting dates to the end of 2025.

Organizational Updates

6. Organizational Changes

We are pleased to share some recent organizational changes at Canada’s Drug Agency.

Effective May 1, 2024, Peter Dyrda will serve as the Interim Director, Pharmaceutical Reviews, and Matthew McDonald will serve as the Acting Director, Pharmaceutical Policy and Health Technology Assessment. 

Additionally, effective May 13, 2024, our Post-Market Drug Evaluation (PMDE) Program is housed under our Evidence, Products, and Services business unit under the leadership of Sudha Kutty, Executive Vice-President. The PMDE Program was successfully launched in 2022 under the leadership of Heather Logan, Vice-President, Strategic Relationships and Initiatives.

Upcoming Consultations

Throughout the summer (July and August), Canada’s Drug Agency will open consultations related to our work in the areas of:

• the development of a document that outlines the methods involved in conducting evidence appraisals
• the process to develop guidance to inform decisions related to newborn screening

Further details will be communicated in upcoming issues of our newsletters (Pharmaceutical Reviews Update and The Dispatch). Subscribe to receive new issues.