ASYMMETRIC CONVERGENCE: MFN AND JCA REFORMS RESHAPE GLOBAL ACCESS STRATEGYBUT ALL EYES ARE ON THE US, NOT EUROPE
Author(s)
Andrea Berardi, MSc1, Emma Hawe, BSc, MSc2.
1Director, Precision AQ, London, United Kingdom, 2Precision AQ, London, United Kingdom.
1Director, Precision AQ, London, United Kingdom, 2Precision AQ, London, United Kingdom.
OBJECTIVES: Two reforms dominated HEOR/market access in 2025-2026: the EU's centralised Joint Clinical Assessment (JCA) and the US Most-Favoured-Nation (MFN) international reference-pricing initiative. We mapped their parallel maturation and tested whether stakeholder attention was symmetric across geographies over the last year.
METHODS: We conducted a retrospective mixed-methods environmental scan (1 June 2025-12 Jun 2026), US/EU stratified, across therapy areas. Anchor-normalised Google Trends (13 terms, Worldwide/US, weekly) were triangulated using three additional layers: policy-event timeline (14 milestones); targeted grey-literature/whitepaper scan (ISPOR, EFPIA/EUCOPE/PhRMA, European Commission, NICE, CMS); qualitative social layer. Geographies were compared using US- to EU-origin search interest ratio.
RESULTS: Both reforms reached operational milestones, with the first EU JCA report (Ojemda) published 9 June 2026, ~18 assessments initiated, and “PICO multiplicity” critiques well identified. US MFN escalated from Executive Order (May 2025) to manufacturer deals, TrumpRx.gov (Feb 2026) and 100% Section-232 tariffs (Apr 2026); a US-UK deal raised the NICE cost-effectiveness threshold. GlobalData reported EU launches down 35% and withdrawals up 43%. Attention was asymmetric: US-origin pricing topics outweighed EU-origin HTA topics (4.5x worldwide and 6.7x within the US). Country-level search confirmed the asymmetry, EU-origin topics drew attention only in Europe (EU-bloc mean 32% share), whereas US devoted 18% to EU topics (aligned with non-European countries). US-origin pricing topics dominated within Europe (Germany/France 75% share).
CONCLUSIONS: US price-setting and EU centralised assessment are converging into a single point of pressure on global access strategy. However, US pricing reforms are a global focus of search interest, EU HTA changes are treated as peripheral by the US public. US-centric global teams may risk systematically under-preparing for EU JCAs, a blind spot that can be prevented with a global evidence strategy.
METHODS: We conducted a retrospective mixed-methods environmental scan (1 June 2025-12 Jun 2026), US/EU stratified, across therapy areas. Anchor-normalised Google Trends (13 terms, Worldwide/US, weekly) were triangulated using three additional layers: policy-event timeline (14 milestones); targeted grey-literature/whitepaper scan (ISPOR, EFPIA/EUCOPE/PhRMA, European Commission, NICE, CMS); qualitative social layer. Geographies were compared using US- to EU-origin search interest ratio.
RESULTS: Both reforms reached operational milestones, with the first EU JCA report (Ojemda) published 9 June 2026, ~18 assessments initiated, and “PICO multiplicity” critiques well identified. US MFN escalated from Executive Order (May 2025) to manufacturer deals, TrumpRx.gov (Feb 2026) and 100% Section-232 tariffs (Apr 2026); a US-UK deal raised the NICE cost-effectiveness threshold. GlobalData reported EU launches down 35% and withdrawals up 43%. Attention was asymmetric: US-origin pricing topics outweighed EU-origin HTA topics (4.5x worldwide and 6.7x within the US). Country-level search confirmed the asymmetry, EU-origin topics drew attention only in Europe (EU-bloc mean 32% share), whereas US devoted 18% to EU topics (aligned with non-European countries). US-origin pricing topics dominated within Europe (Germany/France 75% share).
CONCLUSIONS: US price-setting and EU centralised assessment are converging into a single point of pressure on global access strategy. However, US pricing reforms are a global focus of search interest, EU HTA changes are treated as peripheral by the US public. US-centric global teams may risk systematically under-preparing for EU JCAs, a blind spot that can be prevented with a global evidence strategy.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA124
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas