Canada’s Drug Agency Launches Consultation on Methods Guide

Current consultation status: Open  
Consultation period: November 28 to January 28, 2025

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.

This document describes the methods involved in conducting a health technology assessment (HTA) and focuses on the appraisal of the clinical evidence for a drug as submitted by a sponsor to our Drug Reimbursement Review program.

Our methods guide is part of a suite of drug review guidance documents we have published. These include Guidelines for the Economic Evaluation of Health Technologies: Canada, which details how we conduct economic evaluations, and Guidance for Reporting Real-World Evidence, which provides core reporting standards for real-world evidence in Canada.

The methods guide is intended for use by those who generate and submit evidence, and those who conduct the evidence appraisal. The draft document is posted for consultation for a period of 8 weeks. The deadline to receive feedback from all interested parties is January 28, 2025.

Objectives of Our Methods Guide

Our methods guide aims to:

• highlight the types of clinical evidence that can inform the comparative effectiveness and potential harms of a drug product
• identify key methods and their use in the evaluation of clinical evidence for drug products submitted to us for HTA (reimbursement review)
• facilitate the generation and reporting of the clinical evidence by drug sponsors
• provide transparency in how our reviewers appraise and report on the assessment of clinical evidence.

In developing our guide, we have incorporated leading methodological practices from HTA organizations within Canada and internationally. Our guide will also be a living document that may be updated periodically, as scientific methods evolve and in consultation with users and other interested parties.

Role of HTA in Canada

In Canada, HTA plays a pivotal role in evaluating new and existing drugs to inform decisions about their reimbursement and implementation. The Drug Reimbursement Review program at Canada’s Drug Agency conducts objective evaluations of the clinical and economic evidence submitted by a sponsor. We also seek patient and clinician input and feedback, and may incorporate ethical and implementation considerations. These evaluations inform the deliberations of our expert committees and the drug reimbursement recommendations we deliver to public drug programs and cancer agencies (excluding Quebec).

Goals of the Consultation

The goal of the consultation is to gather feedback from partners and interested parties on aspects of the methods guide that could be enhanced. We will carefully consider feedback that is submitted before publishing the methods guide on our website.

How to Participate

To provide comments on this methods guide, download the draft document and complete the feedback form by January 28, 2025. Questions can be sent to [email protected] with the subject line: Methods Guide Consultation.