OBJECTIVES: Expediting access to pharmaceuticals that address unmet need has resulted in an increase of conditional regulatory approval, known as ‘Notice of Compliance with conditions’ (NOC/c), in Canada. Through NOC/c, drugs can be marketed with a requirement for further studies to address unanswered questions. This research aims to assess how NOC/c approval impacts price negotiation outcomes with the pan-Canadian Pharmaceutical Alliance (pCPA).

METHODS: A comprehensive analysis was conducted on 126 NOC/c drugs (163 indications) authorized from 1998-2023, utilizing Health Canada’s NOC/c database last modified on May 23, 2023. After filtering (discontinued drugs, active or withdrawn HTA submissions with the Canadian Agency for Drugs and Technologies in Health (CADTH), etc.), the final dataset included 103 drugs (135 indications). The pCPA database was assessed for factors including negotiation outcomes and timelines. The dataset was then cross-referenced with CADTH recommendations to identify price reduction recommendations.

RESULTS: 11 Rare Disease (RD), 103 Oncology, and 21 Other indications were included in the analysis. 48% (65/135) were submitted to CADTH, and 43% (58/135) negotiated with the pCPA afterward. 39 indications obtained a successful outcome, 7 are undergoing negotiations, 10 did not pursue negotiations, and 2 negotiations concluded unsuccessfully. The mean negotiation duration was 187 days (0-691 days; 295 days for RD, 166 days for Oncology and 210 days for Other). 56% (23/41) of indications that completed negotiations included a price reduction recommendation from CADTH. 75% of RD, 100% of Oncology, and 100% of Other indications with a price reduction recommendation completed negotiations successfully. 6 indications had price reduction recommendations ≥90%, however, 5/6 (83%) still negotiated successfully.

CONCLUSIONS: NOC/c indications submitted to CADTH have a high likelihood of a positive outcome. However, upon reaching the price negotiation stage with pCPA, 29% did not have a successful outcome. This does not appear to be linked to cost-effectiveness and high price reduction statements.