CADTH opens consultation on draft RWE guidance document for Canada

CADTH invites public feedback from November 2022 until early January 2023 on draft pan-Canadian RWE guidance document for informing the use of RWE in regulatory and reimbursement decision making. A webinar for questions will be held in December 2022, and another in March 2023 to share the results.

On 10 Nov 2022, Canada’s Drug and Health Technology Agency (CADTH), opened a public consultation period inviting feedback on the RWE Steering Committee’s draft RWE guidance document, a pan-Canadian guide that will inform the use of RWE in regulatory and reimbursement decision making. A forum for stakeholder questions will be held by webinar on 2 December 2022 and the consultation period will close on 6 January 2023, with the results being shared by webinar in March 2023.

CADTH chairs Canada’s RWE Steering Committee, a multi-stakeholder initiative that is developing a pan-Canadian strategic framework for the use of RWE in regulatory and reimbursement decision making for drug products by publicly funded drug programs in Canada. RWE is playing an increasingly important role in global regulatory and health technology assessment (HTA) decision pathways. The variety and complexity of RWD sources, study designs, and analytical methods make the evaluation of submissions that include RWE challenging. As capacity and expertise in the generation of RWE increase, there is a need for standardization in the quality of reporting and methodology for HTA and regulatory submissions involving RWE.

In 2021 and 2022, CADTH conducted a Best Brains Exchange learning period with the Canadian Institutes of Health Research and the Canadian Organization for Rare Disorders to explore how to optimize the use of RWE to inform decision making. Learnings from this Best Brains Exchange identified four pillars necessary to support the optimal integration of RWE into decision processes: multi-stakeholder engagement and dialogue; good quality RWD generation and access; cross-sector collaborative partnerships; and RWE guidance, developed in collaboration with the national and international experts who form the RWE Guidance Working Group.

Recent global initiatives have focused on developing tools to improve reporting, transparency and reproducibility of RWE studies. The draft CADTH guidance aligns with existing RWE guidance from international regulators and HTA bodies, while providing strong consideration of the pan-Canadian health care environment. It encompasses both regulatory and reimbursement submissions, rather than covering just one or the other, as some previous reporting guidance documents have.

“As regulatory and reimbursement pathways continue to evolve, real-world evidence is playing an important role in the authorization, value assessment, and post-market supervision of drugs and other health technologies over their life cycle. In Canada, it is imperative that we develop our skills in assessing the evidentiary value of RWE and create shared best practices for reporting RWE studies that reflect the Canadian context.” explained Nicole Mittmann, Chief Scientist and VP, Evidence Standards, CADTH. “CADTH is grateful to the national and international experts who contributed to this guidance document, and we look forward to refining it based on feedback from a broad range of health system stakeholders.”

CADTH will host a webinar for stakeholders on December 2, 2022, in which they will describe the process used to develop the guidance and the type of feedback that CADTH is seeking. It will also provide a forum for stakeholders to ask questions about the consultation process. Register for the webinar here.

Stakeholders can submit feedback online until January 6, 2023 and CADTH will host a second webinar in March 2023 to summarize and anonymously share the type of feedback provided through the consultation process.