Canada’s Drug Agency launched a consultation on their first-ever methods guide. This methods guide is designed to describe the processes involved in conducting health technology assessments (HTAs) and appraising the clinical evidence for drugs submitted to the Drug Reimbursement Review program.

Purpose and Scope

The methods guide aims to clarify the procedures that the agency follows. It details how evidence is evaluated in relation to HTAs for drug reimbursement.

Consultation Details

The consultation period is open from November 28, 2024, to January 28, 2025. This 8-week timeframe allows for feedback from interested parties, including those who generate and submit evidence, as well as those who conduct the evidence appraisal.

Content of the Methods Guide

This guide incorporates leading methodological practices from HTA organizations both within Canada and internationally. It includes the evaluation of clinical and economic evidence, patient and clinician input, and ethical and implementation considerations.

Objectives

The primary goal of the methods guide is to enhance transparency in the agency’s processes and provide a clearer understanding of their work. The agency intends this to be a living document and will update it periodically based on scientific advancements and user feedback.

Application and Use

The methods guide is part of a suite of drug review guidance documents, which also includes:
– Guidelines for the Economic Evaluation of Health Technologies: Canada
– Guidance for Reporting Real-World Evidence.

Stakeholder Engagement

The consultation seeks extensive feedback from partners and interested parties to improve the methods guide. Partners and interested parties can submit feedback by downloading the draft document, completing the feedback form, and sending it to the specified email address by January 28, 2025.

Role in Drug Reimbursement

The HTA process conducted by Canada’s Drug Agency is critical for informing decisions about drug reimbursement and implementation. The agency’s expert committees utilize these evaluations to make recommendations to public drug programs and cancer agencies (excluding Quebec).

In summary, the consultation on the methods guide represents a significant effort by Canada’s Drug Agency to enhance transparency, incorporate best practices, and ensure that their evaluation processes for drug reimbursement are robust and evidence-based.