Pharmaceutical Reviews Update — Issue 55

Program Updates

1. Methods Guide Update

Canada’s Drug Agency  (CDA-AMC) has published our first-ever guidance document on health technology assessment (HTA) methods used in the appraisal of clinical evidence for a drug submitted by a sponsor to our drug reimbursement review program.  

This guidance document builds on national and international best practices used in the appraisal of health technologies. It was developed with input from patient groups, the pharmaceutical industry, other HTA organizations, regulatory bodies, health care professionals, and professional societies, through 2 rounds of consultation.  

The feedback we received was largely positive and recognized the value of this document. We would like to thank everyone who provided input to help shape the final report. The development of the guide is part of our ambition to increase the transparency of our processes and provide a better understanding of our work. 

2. Updated Fees for Drug Reimbursement Reviews

We have updated the Fee Schedule for Pharmaceutical Reviews to include the Schedule B fee for the new Pharmaceuticals With Anticipated Comparable Efficacy and Safety (PACES) tailored review process. The Schedule B fee has been set at 90% of the Schedule A fee. We will apply the Schedule B fee for a 2-year period, after which we will conduct an evaluation and determine if revisions are required. Any sponsors who have questions about the PACES application fee may contact us for more information.

The drug reimbursement review program at CDA-AMC is intended to be a cost-neutral program. The funding for this program is shared between federal, provincial, and territorial funders and industry partners. In 2024–2025, the organization has seen a significant increase in the demand for this program, which has resulted in a forecasted surplus for the year. In light of this, we will not be making any increases to our submission fees at this time; however, we will monitor volumes and review this decision in September 2025 to assess whether a small increase may be needed based on the demand the program experiences through the first half of the fiscal year.

3.  Clarification for Sponsors Submitting Names of Clinical Specialists

Sponsors who would like to suggest the names of clinical specialists who could participate in the reimbursement review for a particular drug must provide that information in the advance notification form at the time the form is initially submitted. CDA-AMC requires that information at the time of initial notification as that is when we initiate the recruitment process. We will not accept revised advance notification forms with the names of clinicians added later in the process. 

4. Clarification for In-Review Meetings  

We have recently introduced in-review meetings to expedite the resolution of submission-related issues that arise during a review. One of the potential items that may warrant an in-review meeting are “important limitations identified with the sponsor’s economic evaluation (e.g., issues that may preclude the generation of a CDA-AMC base case).” We are clarifying that this scenario is intended to refer to situations in which the sponsor has been formally notified by CDA-AMC that the economic model contains important limitations in accordance with Section 6.12.1 of the procedures (e.g., critical errors or other limitations in the sponsor's economic evaluation that preclude CDA-AMC from presenting a base case). CDA-AMC has been receiving requests from industry for in-review meetings to discuss aspects of the CDA-AMC appraisal and reanalyses of the economic model; those items should be addressed through sponsor comments on the draft report. Meetings will not be granted on these matters before receiving sponsor comments and only in exceptional circumstances after the sponsor comments have been addressed.

5. Expert Committee Meeting Schedule

We have posted an updated expert committee meeting schedule for the Canadian Drug Expert Committee (CDEC) and the pan-Canadian Oncology Drug Review Expert Review Committee (pERC). The schedule provides target submission and committee meeting dates up to the December 2026 meetings. Please note that the file location has been updated on our website and sponsors may wish to update their bookmarks to access the file.  

6. Health Economics Methods Advisory Selects First Area for Study

The US-based Institute for Clinical and Economic Review (ICER), England’s National Institute for Health and Care Excellence (NICE), and Canada’s Drug Agency have selected the first research topic for the Health Economics Methods Advisory (HEMA) group: an assessment of the treatment benefits that are appropriate to consider in health technology assessment (HTA) decision-making. You can learn more by reading our announcement published on March 18, 2025.