30 May 2024 - As part of our ongoing initiative to improve and modernise our reimbursement review program, Canada’s Drug Agency is introducing the first phase of process improvements related to companion diagnostics.
Currently, a drug sponsor must include clinical and economic considerations related to companion diagnostics in their applicable reimbursement review submission. To date, the review process has included an evaluation of the clinical utility of the diagnostic test(s), and the evidence has been presented in a clinical review report appendix.