Recently announced changes to CADTH’s Reimbursement Review submission requirements, effective October 2022 necessitates completion of the Sponsor Summary of Clinical Evidence template. The new clinical evidence template is comprehensive, including but not limited to:
- background information on the clinical condition, current treatment paradigm, unmet need, and place in therapy
- methods and findings of a systematic literature search for clinical trials of the drug under review
- summary of evidence from other studies, including observational real-world studies, that fill evidence gaps left by the clinical trials.
The completed template will not be publicly posted, but presents potential opportunities for industry including:
- replacing the clinical summary with a comprehensive document that industry may be confident will be explicitly considered by CADTH
- forward progress in the integration of real-world evidence in the reimbursement process, which may pave the way for future developments, such as outcomes-based agreements.
We would love to hear your thoughts in the comment section below!
