An Analysis of Possible Reference Countries for a US Most-Favored Nation Policy and the Associated Impact on the Global Pharmaceutical Industry

Author(s)

Andrew Mumford, BSc1, Reece Coleman, Apprentice2, Harry Lewis, BA3.
1Initiate Consultancy, Northampton, United Kingdom, 2Initiate Consultancy, London, United Kingdom, 3Initiate Consultancy, Alderton, United Kingdom.
OBJECTIVES: This study evaluated the implications of a possible ‘most favoured nation’ (MFN) pricing policy in the US, as recently outlined by the Trump administration, focusing on global pricing dynamics, pharmaceutical innovation, and the operational capacity of international HTA systems.
METHODS: In total, 16 countries (‘MFN countries’) were identified as being likely references for pharmaceutical pricing in the event that an MFN pricing policy was introduced in the US. Each country was assessed based on its health technology assessment (HTA) body, decision-making criteria (e.g., cost-effectiveness, QALY thresholds), and pricing strategy (e.g., external reference pricing, value-based pricing, free pricing). Policy literature and regulatory data were reviewed to explore potential behavioural responses by manufacturers and systemic effects on global access and innovation.
RESULTS: Among the 16 MFN countries, 8 employ external or reference-based pricing mechanisms, and 11 incorporate cost-effectiveness or QALY-based evaluations (some use both). Countries such as the UK, Sweden, and Canada apply rigorous HTA frameworks, while Germany and Japan allow initial free pricing followed by post-launch amendments. Incorporating these countries into a US MFN pricing model could influence global launch sequencing, as manufacturers may delay or avoid launches in lower-priced markets to protect US benchmarks. Additionally, the use of diverse HTA systems as reference points may create policy spillovers, placing pressure on under-resourced agencies, and potentially prompting alternative pricing strategies.
CONCLUSIONS: The use of MFN countries as reference points in the US IRP model introduces complex challenges extending beyond cost containment. The heterogeneity of pricing systems and HTA methodologies limits the feasibility of direct price alignment. A uniform IRP approach therefore risks distorting global launch strategies and placing undue strain on national pricing and reimbursement systems. To avoid these consequences, policymakers should consider a more flexible framework that accounts for differences in healthcare infrastructure, market dynamics, and value assessment methodologies.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

PT10

Topic

Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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