CADTH RWE Framework
October 20, 2022

Earlier this week, I had the pleasure of attending the The Canadian Association for Population Therapeutics annual conference in Toronto, Canada. The program was titled “Embracing Change and Uncertainty to Improve the Health of Canadians” and it was kicked-off with a townhall session on Canadian RWE Initiatives.

Although the townhall included many prominent speakers and interesting topics, the key bombshell was the imminent release of CADTH’s own RWE framework in November for public consultation.

Compared to other organizations such as Health Canada and INESSS who have been more explicit about their expectations for RWE evidence, guidance from CADTH has been long awaited. Over the past few years, CADTH have been keen to note that they do accept RWE, however due to the vastness of study designs, RWE can range from letters of support to phase IV trials. From a manufacturer perspective, the resources to conduct a comprehensive RWE study for Canadian reimbursement has seemed risky, without knowing how this data would inform decision-making by the committee.

Given the news of a draft CADTH RWE framework being publicly shared within a matter of weeks, attendees of the townhall were keen to know more about this proposed guidance. Mina Tadrous, CAP-T President and Assistant Professor at the University of Toronto has been leading a working group of academics across Canada to prepare the draft guidance for CADTH. The working group’s approach was to conduct a literature review on existing RWE frameworks from other HTA and regulatory organizations and compile existing recommendations on how RWE could inform market access deliberations. Dr Tadrous noted that there were 200 recommendations identified in their literature review, and the working group deployed a questionnaire to an expert panel to rank the recommendations for relevance to Canadian HTA decision-making. There was alignment for including the vast majority of recommendations, and these will form the basis of the CADTH RWE framework. (I must admit I am a fan of this pragmatic approach to not “reinvent the wheel” by adopting recommendations from other countries who have more experience with incorporating RWE into the decision-making process).

Among the various sessions, there was an emphasis on the need for alignment between regulators (Health Canada), reimbursement (CADTH/INESSS), and payer organizations across Canada to determine how and when RWE can be leveraged to inform decision-making. CADTH described their initiatives with Health Canada, and international HTA organizations, to facilitate this alignment, but the alignment with payers in Canada, including involvement in the Early Scientific Advice process, was notably absent.

RWE partnerships were discussed with pan-Canadian coordination, including the CADTH RWE steering committee and implementing a multistakeholder approach going forward. CADTH emphasized a mutual need for trust and transparency, and how their current initiatives are focused on collaboration.

Perhaps my key take-away, beyond the imminent RWE framework, was the need to include patient perspectives in the design of RWE studies, including the data collection process to understand and prioritize what outcomes are most important to patients. These outcomes should be at the heart of HTA decisions to improve and truly impact patient lives.