Performance

Any submission may be filed on a pre-NOC basis up to 180 calendar days in advance of the anticipated date of decision by Health Canada. Participation in the pre-NOC submission process is encouraged to limit the interval between Health Canada approval and the issuance of the CADTH reimbursement recommendation. In the 2023-2024 FY, 46 of 67 initial submissions were filed on a pre-NOC basis.

As described in Health Canada’s Notice to Industry: Aligned Reviews Between Health Canada and Health Technology Assessment Organizations, an optional information-sharing process for submissions filed with CADTH on a pre-NOC basis has been established to permit Health Canada and CADTH to exchange information regarding a drug under review. Participation in this process can ensure that CADTH has advance notice of any issues that have the potential to have an impact on CADTH’s review of a drug (e.g., changes to the indicated patient population), which can help avoid delays in the issuance of CADTH’s recommendations. Sponsors consented to participation in the aligned review process for 37 of 46 submissions filed on a pre-NOC basis in the 2023–2024 fiscal year.