CADTH Pharmaceutical Reviews Update — Issue 42

Program Updates  

 1. Revised Confidentiality Guidelines 

In April 2023, Canada's Drug Agency published Confidentiality of Clinical Evidence Informing Health Technology Assessment Decision-Making, a joint position statement with the Institute for Clinical and Economic Review (ICER) in the US and the National Institute for Health and Care Excellence (NICE) in England. This statement indicated that, beginning in May 2023, Canada's Drug Agency would not routinely redact clinical data that are awaiting publication when we publish our recommendations, guidance, or decisions. Canada's Drug Agency also indicated that engagement with industry would follow to identify a reasonable approach to implementation.

Canada's Drug Agency has engaged with the pharmaceutical industry and considered various options regarding implementation of the new confidentiality guidelines. Following careful consideration, Canada's Drug Agency has adopted the principles currently used by NICE, with minor modifications to account for differences in the process (e.g., confidential pricing arrangements are not accepted by Canada's Drug Agency). Canada's Drug Agency has made this decision to increase alignment with our international health technology assessment partners and to offer the industry greater consistency in how confidential information is managed by Canada's Drug Agency relative to other jurisdictions.

Revisions to the confidentiality guidelines are provided in the updated version of the Procedures for Canada's Drug Agency Reimbursement Reviews (refer to Appendix 1). In accordance with the approach used by NICE, Canada's Drug Agency has introduced a new section on minimum reporting requirements for information that has been or will not be publicly disclosed by industry.  

These revised guidelines are effective for all new applications received on or after January 2, 2024.  

2. Revised Ethics Review Template

Canada's Drug Agency has made a minor revision (removal of Table 1) to the template used for Ethics Reviews conducted in the context of complex Reimbursement Reviews.  

3. Clarification of Pharmacoeconomic Requirements  

In response to feedback from industry stakeholders, Canada's Drug Agency has clarified the following details of the pharmacoeconomic submission requirements: 

• Scenario analyses submitted to Canada's Drug Agency for the pharmacoeconomic technical report will no longer need to be presented probabilistically provided that probabilistic results can still be generated.
• Drug price values in the budget impact analysis should be identical across all participating drug programs (i.e., each drug has the same value across each program), even in cases in which other costs must be specific to each individual program.

4. Posting Draft Recommendations  

In response to requests from stakeholders, Canada's Drug Agency has revised its processes and will keep draft reimbursement recommendations posted on our website until the final recommendation is published. Previously, the draft recommendation was removed at the close of the stakeholder feedback period.