Canada’s Drug Agency launches consultation on health technology assessment methods guide

The agency’s first HTA methods guide aims to enhance transparency, evidence evaluation, and reimbursement decision-making.

Canada’s Drug Agency (CDA-AMC) has launched a public consultation on its first-ever methods guide, open from November 28, 2024, to January 28, 2025. This initiative aims to enhance transparency and improve understanding of the agency’s work, focusing specifically on the methods used in health technology assessments (HTA).

The Methods Guide for Health Technology Assessment focuses on evaluating clinical evidence for drug products submitted through CDA-AMC’s Drug Reimbursement Review program. It is designed to support both those generating and submitting evidence and those conducting appraisals. Stakeholders are invited to review the draft document and provide feedback during the 8-week consultation period.

The agency highlighted the importance of stakeholder input in shaping the final guide, stating:

“Our guide will be a living document that may be updated periodically, as scientific methods evolve and in consultation with users and other interested parties.”

Purpose and objectives of the methods guide

The methods guide is part of a suite of drug review guidance documents, which also includes the "Guidelines for the Economic Evaluation of Health Technologies: Canada" and "Guidance for Reporting Real-World Evidence." Together, these documents form the backbone of CDA-AMC's approach to HTAs, addressing clinical, economic, and real-world evidence (RWE) considerations.

The guide’s primary objectives are to enhance the transparency and consistency of CDA-AMC’s assessments while supporting stakeholders in their contributions. Specifically, the guide aims to:

1. Define clinical evidence: Clearly outline the types of evidence required to assess the comparative effectiveness and potential harms of drug products.
2. Detail key methods: Provide guidance on the core methodologies used in evidence evaluation for HTA and reimbursement reviews.
3. Support evidence generation: Assist drug sponsors in preparing and reporting robust evidence for submissions.
4. Ensure transparency: Clarify how reviewers appraise and report on clinical evidence, ensuring transparency in the evaluation process.

The guide incorporates best practices from leading Canadian and international HTA organizations, ensuring it reflects the latest methodologies. It also allows for flexibility, acknowledging that unique circumstances may require tailored approaches for specific drugs or indications.

CDA-AMC invites stakeholders, including healthcare professionals, patient organizations, and the pharmaceutical industry, to review the draft methods guide and submit their feedback by January 28, 2025.