Methods Guide

As part of our efforts to increase the transparency of our processes, we have developed a methods guide. 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.

The 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 submitted drug products
• facilitate the generation and reporting of the clinical evidence by sponsors
• provide transparency in how we review, appraise, and report on the assessment of clinical evidence.

This document is intended for use by those who generate and submit evidence, and those who conduct the evidence appraisal. 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.

The draft methods guide was posted for consultation and is now closed; the final document will be published this spring.