On May 3, 2022, CADTH announced the mandate expansion of the Scientific Advice Program to include advice on RWE generation plans after protocols for pivotal trials are finalized.
What to know:
- The expanded program will run for a 1-year learning period. Any request for advice on RWE generation plans will be considered until March 31, 2023, and must include questions related to RWE generation plans; questions on economic modelling may also be included.
- Questions will need to be submitted through the established CADTH Scientific Advice processes after pivotal trial protocols have been finalized.
- Priority will be given to rare diseases.
- This is a unique opportunity for industry to engage with CADTH, discuss the challenges associated with collecting RWE appropriate for HTA, and provide insights for the RWE guidance and standards being developed by CADTH.
- CADTH Scientific Advice services – which includes advice on early drug development plans from a CADTH perspective – continue to be offered.
- Health Canada and CADTH RWE action plan is still in development. The plan is aimed at optimizing the process for systematically using and integrating RWE into both regulatory and reimbursement decision-making in Canada.
While it remains unclear at this time how the work of the Scientific Advice Program on RWE generation will affect negotiations and reimbursement, this announcement does align with CADTH’s 2022-25 Strategic Plan. One of its goals over the next three years is that RWE will be utilized in CADTH recommendations where appropriate and used to inform health system decisions.
For more information, please consult the CADTH news.
Please contact Ara Salazar, Director, Market Access at ara.salazar@pdci.ca for any questions or further information.