OBJECTIVES: The growing need to expedite access to pharmaceuticals for areas with substantial unmet needs has resulted in an increase in the utilization of a conditional regulatory pathway known as Notice of Compliance with conditions (NOC/c). Through NOC/c, a drug can be marketed with the condition that the sponsor conducts further studies to validate its clinical benefits. This study aims to assess how conditional regulatory approval impact 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. Drugs that were discontinued, had withdrawn conditions, or had active or withdrawn HTA submissions were excluded from the analysis, resulting in a final dataset of 103 drugs (135 indications). The pCPA Negotiation Status database was assessed for factors including the negotiation outcome and time taken to complete negotiations.

RESULTS: 11 Rare Disease (RD), 103 Oncology, and 21 Other indications were included in the analysis. 43% (58/135) NOC/c indications went to pCPA and 48% (65/135) were submitted to CADTH. 39 indications obtained a positive outcome at pCPA, 7 are undergoing negotiations, 10 were not able to pursue negotiations, and 2 negotiated without an agreement. The mean duration of negotiations at pCPA was 187 days (0-691 days), with specific mean durations of 295 days for RD, 166 days for Oncology, and 210 days for Other indications. 6 drugs had a price reduction recommendation ≥90%, however, 5/6 still received a positive outcome at pCPA.

CONCLUSIONS: NOC/c drugs have not shown difficulty in receiving a positive negotiation outcome at the pCPA. Moreover, the comparable numbers of NOC/c drugs undergoing pCPA and CADTH evaluations suggest that manufacturers are likely making strategic decisions when selecting which drugs to submit for HTA.