US MOST FAVOURED NATION PRICING AND EU JOINT CLINICAL ASSESSMENT: A CEE-WEIGHTED PULSE CHECK ON LAUNCH STRATEGY, EVIDENCE GENERATION AND ACCESS RISK
Author(s)
Vishwas R. Agashe, PhD, MSc, BSc1, Sanja Stanisic, MSc2, Malwina Holownia-Voloskova, MPharm, PhD3, Jacek Walczak, MD3, Roman Casciano, MS4.
1Certara Evidence & Access, Oxford, United Kingdom, 2Certara, Inc, Milan, Italy, 3Certara, Cracow, Poland, 4Certara USA Inc., Mamaroneck, NY, USA.
1Certara Evidence & Access, Oxford, United Kingdom, 2Certara, Inc, Milan, Italy, 3Certara, Cracow, Poland, 4Certara USA Inc., Mamaroneck, NY, USA.
OBJECTIVES: To assess how market access professionals perceive global launch, pricing and evidence-generation implications of two concurrent policy shifts: the US Most-Favoured-Nation (MFN) pricing framework and EU Joint Clinical Assessment (JCA).
METHODS: An online pulse-check survey was conducted from 14 May to 23 June 2026 among market access, HEOR, commercial and leadership professionals. Twenty-six responses were analysed descriptively as a global industry readout with a Central and Eastern Europe (CEE)-weighted case study, as 69% were CEE-based. Likert items were reported as top-2-box agreement; free text was reviewed thematically. AI-assisted tools supported survey design and analysis; outputs and interpretations were reviewed and approved by the authors.
RESULTS: Respondents reported moderate MFN awareness (58% somewhat, 15% very familiar). 69% reported MFN impact varying by drug portfolio; 58% reported potential reference-basket expansion was already influencing pricing outside baskets; 69% were more cautious about list prices and 54% reported accelerating confidential pricing. The leading perceived MFN risk was upward price pressure reducing patient access (42%), followed by launch delays (35%). JCA was perceived less as simplification than evidence-system shift: 62% agreed it would increase launch complexity and cost, 58% that organisations were investing earlier in integrated evidence generation, and 58% that it would strengthen smaller-market HTA capacity; only 31% agreed JCA would enable simultaneous EU launches (versus 38% disagreeing). The future role of smaller/lower-GDP markets remained contested (35% more important; 31% no change; 23% less important). CEE respondents were directionally more optimistic than non-CEE respondents on non-basket launch attractiveness and future market importance.
CONCLUSIONS: This global, CEE-weighted pulse check suggests MFN and JCA are prompting reassessment but not decisive resequencing. The central tension is whether MFN’s affordability-driven pricing pressure and JCA’s harmonisation-driven evidence requirements may reshape launch incentives in ways that increase pricing opacity, evidence demands and access uncertainty in smaller markets.
METHODS: An online pulse-check survey was conducted from 14 May to 23 June 2026 among market access, HEOR, commercial and leadership professionals. Twenty-six responses were analysed descriptively as a global industry readout with a Central and Eastern Europe (CEE)-weighted case study, as 69% were CEE-based. Likert items were reported as top-2-box agreement; free text was reviewed thematically. AI-assisted tools supported survey design and analysis; outputs and interpretations were reviewed and approved by the authors.
RESULTS: Respondents reported moderate MFN awareness (58% somewhat, 15% very familiar). 69% reported MFN impact varying by drug portfolio; 58% reported potential reference-basket expansion was already influencing pricing outside baskets; 69% were more cautious about list prices and 54% reported accelerating confidential pricing. The leading perceived MFN risk was upward price pressure reducing patient access (42%), followed by launch delays (35%). JCA was perceived less as simplification than evidence-system shift: 62% agreed it would increase launch complexity and cost, 58% that organisations were investing earlier in integrated evidence generation, and 58% that it would strengthen smaller-market HTA capacity; only 31% agreed JCA would enable simultaneous EU launches (versus 38% disagreeing). The future role of smaller/lower-GDP markets remained contested (35% more important; 31% no change; 23% less important). CEE respondents were directionally more optimistic than non-CEE respondents on non-basket launch attractiveness and future market importance.
CONCLUSIONS: This global, CEE-weighted pulse check suggests MFN and JCA are prompting reassessment but not decisive resequencing. The central tension is whether MFN’s affordability-driven pricing pressure and JCA’s harmonisation-driven evidence requirements may reshape launch incentives in ways that increase pricing opacity, evidence demands and access uncertainty in smaller markets.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
P40
Topic
Health Policy & Regulatory, Health Technology Assessment, Organizational Practices
Topic Subcategory
Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas