Presentation (CTI)

OBJECTIVES: In July 2025, the US Most-Favoured-Nation (MFN) drug pricing policy escalated when formal letters were issued to 17 pharmaceutical manufacturers, setting expectations for US prices to be aligned with those of economically comparable OECD countries. The introduction of MFN has created uncertainty around ex-US drug pricing, particularly in reference markets such as Canada. This study evaluates whether MFN has influenced manufacturer behaviour in Canada, with a focus on potential delays or shifts in engagement with the pan-Canadian Pharmaceutical Alliance (pCPA).
METHODS: Publicly-available pCPA dashboard data were analysed to compare negotiation trends before and after July 2025. Key extracted information includes the number of active negotiations, new engagements, and files under consideration. Sensitivity analyses were conducted using alternative cutoffs in May 2025 and September 2025 to capture early policy signalling and the initial period following the July escalation.
RESULTS: No reduction in pCPA negotiation activity was observed following the July 2025 MFN escalation. Activity remained consistently high through 2025 and into 2026, with active negotiations reaching approximately 49 files in August 2025 and stabilising at ~45 in early 2026, while files under consideration declined to ~17. Broader trend data indicate a sustained increase in active negotiations from the mid‑20s in 2023 to >40 by 2025. Findings were consistent across alternative cutoffs, with no observable inflection in volumes or evidence of backlog accumulation. However, MFN-related behavioural shifts may be occurring upstream, including delayed HTA submission, adjusted launch sequencing, cautious pricing strategies, or extending timelines to limit reference price exposure.
CONCLUSIONS: MFN does not appear to have reduced pCPA negotiation activity in the short term. Instead, its impact is more nuanced, influencing launch timing and negotiation strategy rather than participation. Monitoring upstream access milestones will be critical to understand the longer-term implications for Canadian market access.