About the CADTH/CAPT/Health Canada/IHE Real World Evidence Workshop

21 October 2018
Toronto, Ontario

On October 21, 2018, Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), the Institute of Health Economics (IHE), and the Canadian Association for Population Therapeutics (CAPT) collaborated on Defining Decision-Grade Real-World Evidence and its Role in the Canadian Context: A Design Sprint. Held as a satellite to the 2018 CAPT conference in Toronto, Ontario, the full-day interactive workshop brought together 87 individuals from different sectors, including regulators, public payers, clinicians/healthcare providers, academics, health technology assessment agencies, patient group representatives, and industry.

The objectives of the workshop were to:

1. identify the value and application of RWE in supporting pharmaceutical regulatory and reimbursement decision-making; and
2. identify the conditions upon which RWE will be considered of sufficient quality to inform decision-making.

Download Summary Report (English)

Defining decision-grade real-world evidence and its role in the Canadian context: A design sprint – Summary report of a workshop

Téléchargez le rapport sommaire d’un atelier (Français)

Définir les données probantes du monde réel utiles à la prise de décisions et leur rôle en contexte canadien: Un sprint de conception Rapport sommaire d’un atelier

Next Steps

Building on the momentum created by the workshop, CADTH and Health Canada are now partnering on three key initiatives in the RWE space.

First, they are developing a joint framework for the integration of RWE into regulatory and reimbursement decision-making in Canada. The framework will outline the intent to optimize the use of RWE across the health product lifecycle in Canada, and the steps that will be taken to get there. The target for completion of the framework is early April 2019.

Second, an advisory group will be established by December 2018 to guide and support the development of the RWE framework and corresponding processes. In addition, working groups will be established to further progress in key areas such as data collection and data access. CADTH and Health Canada will reach out to relevant stakeholders as this work progresses.

Third, phasing in the expanded use of RWE for regulatory and reimbursement decision-making will begin by spring of 2019. Health Canada and CADTH plan to solicit industry submissions with RWE for certain groups of products to jointly work through the process.

To sign up for regular updates from CADTH, please send an email to [email protected] with RWE Updates as the subject.

For further information from Health Canada, please email [email protected].

For further information regarding the meeting report, please email [email protected].