Pharmaceutical Reviews Update — Issue 53

Program Updates

1. Consultation on Our Methods Guide

Canada’s Drug Agency is launching a consultation on our first-ever Methods Guide. The development of the guide and our open consultation are both part of our ambition to increase the transparency of our processes and provide a better understanding of our work.

The Methods Guide describes the methods involved in conducting health technology assessment (HTA) and focuses on the appraisal of the clinical evidence for a drug product that is submitted by a sponsor to our Drug Reimbursement Review program. Our guide is intended for use by those who generate and submit evidence, and those who conduct the evidence appraisal.

Refer to our announcement to access the document and instructions on how to submit feedback. The document is posted for consultation for a period of 8 weeks, and the deadline to receive feedback from all interested parties is January 28, 2025.

2. Improving the Presentation of Pharmacoeconomic Information in the Reimbursement Review

For each Drug Reimbursement Review that Canada’s Drug Agency conducts, we publish a combined review report that presents our appraisal of the clinical and pharmacoeconomic evidence for a drug.

We are implementing improvements to the pharmacoeconomic portion of this report that will increase the transparency of our results and ensure the information decision-makers rely on is easily accessible.

Key changes include the following:

• Shorter report: The main body of the new report will be 5 pages maximum (from 30 to 35 pages previously).
• New Key Messages section: We will highlight key messages for decision-making from the pharmacoeconomic review in the first 5 pages. This will focus on the implications in terms of costs and benefits of the drug under review.
• Removing the focus on a single willingness-to-pay threshold: The conclusions and price reductions no longer focus on a single willingness-to-pay threshold.
• New figures and tables: New figures and tables have been developed to highlight results in easy-to-digest and informative ways for decision-makers.
• Revised supplemental information: We will include the full critical appraisal and additional information about the submission in the appendices.

These changes to our report template were informed by consultations with our expert committee members and participating public drug plans. In collaboration, we developed an updated report template that will provide a high-level overview while continuing to provide the detailed information about the economic model appraisal that is needed by some users in certain circumstances.

We anticipate that drug sponsors will review reports with the improved pharmacoeconomic template in spring 2025.

3. Announcing the Health Economics Methods Advisory

Canada’s Drug Agency is partnering with the Institute for Clinical and Economic Review (ICER) in the US and the National Institute for Health and Care Excellence (NICE) in the UK to establish the Health Economics Methods Advisory (HEMA) group.

The HEMA group will work together to:

• convene an independent working group of methodologists, policy experts, and researchers dedicated to improving understanding of novel health economic methods and related decision-making processes within the context of HTA
• coordinate the development of white papers, peer-reviewed publications, workshops, and seminars that focus on the conceptual and empirical applications of novel methods, assess their applicability and feasibility in HTA settings, and share research and policy perspectives with a broad set of HTA users
• Provide recommendations to the HTA community on the adoption of novel methods, modifications that might be needed, uncertainties in methods application, and suggestions for further research.

If you have questions about these updates, please contact at [email protected].