Pharmaceutical Reviews Update — Issue 56

Program Updates

1. Further Streamlining the Tailored Review Process

Since the launch of the Pharmaceuticals With Anticipated Comparable Efficacy and Safety (PACES) process in February 2025, we continue to examine opportunities to further simplify the application and review process.

Effective immediately, we have revised the PACES process and will no longer require sponsors to submit a cost-minimization analysis as part of the application. In lieu of the cost-minimization analysis, sponsors are now only required to complete a cost comparison section within the tailored review submission template (i.e., as is currently done for product variation tailored reviews).

These changes are reflected in the updated tailored review template that is available on our website and will be incorporated into a revised procedures document in the coming months.

2. New Name for Oncology Advisory Committee  

We have revised the name of the jurisdictional advisory committee for oncology drugs from the Provincial Advisory Group (PAG) to the Oncology Working Group (OWG). This change is effective immediately and will be incorporated into a revised procedures document in the coming months.

3. Clarifications for Reimbursement Reviews Procedures

3.1. Revisions to the Sponsor’s Proposed Reimbursement Criteria

We have been receiving requests from drug sponsors to revise their requested reimbursement criteria when providing responses to sponsor comments. We are clarifying that such requests will not be permitted unless the change being requested is a direct result of a revision to the indication that has been approved by or is undergoing review by Health Canada (i.e., this will only be permitted for select pre-Notice of Compliance [NOC] submissions).  

We have attempted to accommodate these requests, but revisions to the proposed reimbursement criteria require updates to the clinical and economic reports and may require additional consultation with clinical experts. Given the timelines for the drug reimbursement review process, this can no longer be accommodated after the draft reports have been issued to the sponsor.

3.2. Reminder Concerning the Submission of Updated Data Cuts or Analyses

We are reminding drug sponsors that they are responsible for ensuring that all relevant clinical and economic information has been provided to Canada’s Drug Agency (CDA-AMC) for applications.  

We have recently encountered a situation where a sponsor had updated clinical information that they considered to be relevant for the application but did not submit because they did not receive an additional information request from CDA-AMC. Sponsors are reminded that the planned or anticipated submission of updated clinical trial information must be disclosed to CDA-AMC at the outset of the review in accordance with the instructions outlined in the Procedures for Reimbursement Reviews and the applicable submissions template (i.e., application overview and table of studies template).  

In all cases, the sponsor is responsible for providing the required details of when the information will be submitted and for providing the information in a format that allows for a detailed review and appraisal by CDA-AMC (i.e., conference abstracts are not an acceptable format).

We emphasize that the onus is on the sponsor to ensure a clear understanding of the reimbursement review procedures and that our team is always available to respond to inquiries about procedural matters. In addition, we offer presubmission meeting opportunities to discuss any questions regarding pending applications. Sponsors with procedural questions should contact us to ensure a clear and accurate understanding of the application and review procedures.

We are also issuing a clarification about any communication with us regarding economic or budget impact models. If a sponsor determines that a new economic or budget impact model needs to be submitted, but this submission has not been requested by CDA-AMC, the sponsor must:

• initiate a unique communication to CDA-AMC on this topic, with a detailed rationale for the new model, and
• follow the guidance set out in section 8.4.2 of Procedures for Reimbursement Reviews.  

Any new economic or budget impact model must not be submitted to CDA-AMC in any communication on a different topic or in response to an unrelated request for information from us.  

3.3. Revisions to the Confidentiality Guidelines

We have revised the confidentiality guidance related to the redaction of population size and market share values based on unpublished information from market research obtained from a third party to denote that evidence of the commercial in confidence nature of the information is sufficient for redaction. This change is effective immediately and will be incorporated into a revised procedures document in the coming months.  

Budget impact analysis 

Table 1: Confidentiality Guideline Revisions

CDA-AMC = Canada’s Drug Agency.