CADTH Pharmaceutical Reviews Update — Issue 37

Canada's Drug Agency Program Updates 

1.  Implementation of GRADE in Canada's Drug Agency Reimbursement Reviews 

As part of an organization-wide initiative, Canada's Drug Agency is adopting the GRADE approach for communicating the level of certainty of a body of evidence within Canada's Drug Agency Reimbursement Reviews. Developed by an international working group, GRADE stands for Grading of Recommendations Assessment, Development, and Evaluation, and it is a widely adopted tool for rating the certainty in the evidence.  

The GRADE approach will be implemented for systematic review evidence in the Canada's Drug Agency clinical review report for all oncology drug applications received starting April 26, 2023 and all non-oncology drug applications received starting April 5, 2023. A level of certainty of the evidence (very low, low, moderate, or high) will be assigned for each outcome based on considerations within 5 standard domains, and the rationale for each decision will be provided. A new table in the Executive Summary section will present this information in a standardized format. 

The objective of using GRADE within the Canada's Drug Agency Reimbursement Reviews is to improve communication within the clinical review reports. It will not change how the evidence is assessed by the Canada's Drug Agency review teams; rather, GRADE will provide greater consistency, transparency, and structure in how the assessments are communicated. The introduction of GRADE into Reimbursement Reviews will not affect submission requirements or review timelines. It will also not affect the expert committee’s deliberative or recommendations frameworks. Moving forward, Canada's Drug Agency will continue to explore approaches for transparently communicating results of the evidence appraisal in other sections of the Clinical Review report. 

2.  New Implementation Advice for Medical Imaging 

Canada's Drug Agency is pleased to announce new procedures for issuing implementation advice related to medical imaging. The new process will leverage the Canada's Drug Agency Canadian Medical Imaging Inventory and involve consultation with Canadian specialists in nuclear medicine and radiology to issue advice to facilitate the introduction of new complex drugs into the health system. The new procedures will build on the processes currently used to develop provisional funding algorithms for oncology drugs, including opportunities for stakeholder input and feedback.  

Complete details of the new process are reported in Canada's Drug Agency Procedures for Medical Imaging Implementation Advice. 

The first project is now underway on the topic of prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The proposed scope for this project is now open for stakeholder feedback.

3.  Consultation on Time-Limited Reimbursement Recommendations 

Consultation on the proposal to introduce time-limited reimbursement recommendations closed on May 1, 2023. Canada's Drug Agency received 31 responses from a variety of stakeholders, including the pharmaceutical industry, patient and clinician groups, consulting companies, and public drug programs. We are currently reviewing the feedback and will communicate next steps in the coming weeks. We thank all stakeholders who provided feedback on the proposal.