Accelerating Oncology Drug Reimbursement in Canada: Impact of the CDA-AMC Time-Limited Recommendation and pCPA Temporary Access Process.

ABSTRACT: The complex pathway for new drug reimbursement in Canada has been well documented. Drugs with promising early efficacy data may receive a Notice of Compliance with Conditions (NOC/c) from Health Canada. For oncology drugs that receive NOC/c, the pathway through positive review by Canada's Drug Agency (CDA-AMC) and subsequent public reimbursement can take over 500 days. To address this challenge, in September 2023, CDA-AMC announced a new Time-Limited Recommendation (TLR) category, and in parallel, the pan-Canadian Pharmaceutical Alliance (pCPA) developed a set of principles and conditions for a Temporary Access Process (pTAP). This accelerated access pathway, the first of its kind in Canada, enables patients with advanced diseases to gain timely access to promising therapies while managing

SUBMITTER: Lau CY 

PROVIDER: S-EPMC12025630 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature