Session (CTI)

Issue: Market access strategy is being reshaped by evolution of EU and US policy reforms that place competing emphasis on evidence generation and pricing. EU Joint Clinical Assessment (JCA) increases the need for robust, standardized comparative evidence that withstands scrutiny across Member States. Emerging US pricing policies threaten to link some US prices to lower international benchmarks. Together with revisions to EU General Pharmaceutical Legislation, these shifts create unprecedented pressure on manufacturers to generate evidence that delivers both EU wide clinical value and price corridors aligned to the evolving US landscape. Overview: This panel explores how EU and US policy intersection is reshaping evidence strategy, pricing, and development decision making, through the distinct perspectives of industry, EU HTA, and US policy. Aodan Tynan provides an industry view on how JCA, compounded by US MFN pricing, is already altering clinical development priorities: While development programs should be redesigned early to accommodate EU wide comparators, endpoints and populations, focus is shifting to supporting pricing strategies compatible with the evolving US landscape. Niklas Hedberg argues, as an EU HTA stakeholder, that JCA’s emphasis on robust, patient relevant evidence applicable across Member States is both appropriate and overdue. JCA represents a step forward in improving consistency and equity in European decision making, and its scientific ambition should not be compromised by short term pricing dynamics outside the EU. Duane Schulthess offers a complementary US perspective, highlighting that MFN style reforms are grounded in principles of greater US EU equity in funding pharmaceutical innovation. While disruptive, this objective is viewed as legitimate and necessary but may have implications for EU access. Each participant presents their perspective (30 mins), followed by moderated discussion and audience Q&A (~20 mins) to highlight consensus and disagreements on how goals can be reconciled without undermining evidence, innovation incentives, or patient access – a topic relevant to industry, HTA and policy stakeholders.