Presentation (CTI)

OBJECTIVES: To investigate the global impact of US drug pricing policies (such as the Inflation Reduction Act and Most favored Nation) on pharmaceutical launch strategies, explore the impact on ex-US stakeholders and examine potential reforms.
METHODS: A preliminary quantitative analysis was conducted comparing FD approval statuses with subsequent ex-US Health Technology Assessment (HTA) submissions (e.g., HAS, G-BA, NICE and TLV) for oncology and rare disease therapies. The initial data revealed variable submission timelines and launch statuses, lacking a singular correlative factor, subsequently convening an expert panel assessing the overarching trends in global launch sequencing, and a targeted search to summarize these trends by country.
RESULTS: The initial comparative data analysis demonstrated inconsistent ex-US launch delays, ranging from simultaneous launches to extended delays or complete non-launches, highlighting a multifactorial decision-making environment. Building upon these inconclusive findings, the expert panel suggested that broader pricing pressures including international reference pricing, IRA and MFN, could fundamentally be reinforcing the "US-first" launch strategies. This could lead to inflation of ex-US list prices or delays in European rollouts to protect US revenues. In response to these access delays, ex-US payers and HTA bodies are implementing reforms such as increase in ICER threshold (NICE), proposed changes in pricing and reimbursement (Germany, France and Sweden) and the new-drug launch fund (Switzerland). Cross-country initiatives such as Beneluxa are also gaining traction.
CONCLUSIONS: Although the launch timing data presented a fragmented scenario, experts agreed that US pricing reforms are causing a global impact on pricing and reimbursement and pushing the manufacturer to rethink their access strategies. This changing environment will require earlier and integrated collaborations across different stakeholders to support access in multiple countries.