Pharmaceutical Reviews Update — Issue 52

Program Updates 

1. Updates to the Pharmacoeconomic Submission Process and Submission Requirements 

Making Our Economic Model Change Logs More Transparent to Our Partners 

Transparency is essential in economic modelling to make complex analyses more understandable, reliable, and actionable. We are taking a new step to increase the transparency around how we handle economic models that are submitted by a drug sponsor as part of a drug reimbursement review.

Effective November 1, 2024, we will distribute a Model Change Log to the drug sponsor, participating public drug plans, and the pan-Canadian Pharmaceutical Alliance (pCPA).

The Model Change Log will be shared as a separate document that details specific changes made to the economic model submitted by a sponsor, aligned with the steps described in our pharmacoeconomic report, to derive our base case. The Model Change Log will be distributed at 2 points in our process:

1. with the draft pharmacoeconomic report that is provided to a drug sponsor, the participating public drug plans, and the pCPA
2. with the final redacted pharmacoeconomic report that is provided to the same partners. 

We are initiating this change to proactively increase the transparency of our work and make it easier for partners to efficiently replicate our analyses. The Model Change Log will not be shared publicly.

Unprompted Submission of New or Revised Models by Drug Sponsors Within the Review Period 

In some instances, drug sponsors have been submitting updated economic and/or budget impact models after the original pharmacoeconomic information has been accepted. This is often in response to the identification of errors by the sponsor. 

Because model appraisal starts early in the review process, receiving updated economic models during the review period complicates our review. If a sponsor identifies an issue in a model that has already been accepted, the sponsor must promptly notify Canada’s Drug Agency of the issue. Depending on the nature of the issue, we may ask the sponsor to submit a detailed summary of the changes required to address the error (e.g., Model Change Log) in addition to a corrected model. We discourage drug sponsors from submitting new model files without notifying us in advance. 

Use of IFERROR Statements in Economic Models

In our pharmacoeconomic reports, Canada’s Drug Agency often highlights the inclusion of IFERROR statements in economic model files as a limitation. The use of these statements modifies the output of the model file, masking errors and making it difficult to undertake a thorough appraisal of the model. 

To address this ongoing issue, we have added a requirement that IFERROR statements should not be used in economic or budget impact models submitted as part of drug reimbursement reviews. This update to our submission requirements will allow us to review economic models more efficiently and ensure that a full audit of the model can occur. 

If an economic model using IFERROR statements in the formulas is submitted, we will accept it but will continue to highlight the quality issues and a lack of alignment with best practices in our pharmacoeconomic reports.