Presentation (CTI)

OBJECTIVES: The Most Favoured Nation (MFN) framework is structurally an international reference pricing (IRP) mechanism: benchmarking US prices against countries including Germany, France, and the UK where prices are set through formal HTA reflecting foreign willingness-to-pay (WTP) thresholds and cost structures. While MFN incorporates Gross Domestic Product purchasing power parity (PPP) adjustments, this macroeconomic proxy cannot substitute for US-specific value assessment. We examine MFN's structural limitations and the case for a national US HTA agency.
METHODS: A targeted literature review used PubMed, Google Scholar, and grey literature from CMS, the White House Council of Economic Advisers, Institute for Clinical and Economic Review (ICER), and HTA agencies including NICE (UK), G-BA (Germany), and HAS (France). Records published 2016-2026 in English were included, extracting: MFN policy features and limitations; HTA-specific pricing parameters (WTP thresholds, cost-effectiveness criteria) from reference countries; and evidence on HTA agency benefits, including US-focused analyses.
RESULTS: Three interconnected limitations of MFN pricing were identified: (1) Validity of reference prices: MFN benchmarks reflect prices calibrated to foreign WTP thresholds and cost-effectiveness standards; importing them into the US embeds unjustified foreign value judgements; (2) Inadequacy of GDP-PPP adjustment: GDP-PPP cannot account for differences in disease burden, treatment pathways, or societal WTP; a US HTA agency would enable principled, context-specific adjustments; (3) Lack of systemic HTA benefits: established agencies reduce assessment duplication, improve pricing transparency, and better align drug prices with outcomes.
CONCLUSIONS: MFN pricing is a pivotal policy shift, but as an IRP mechanism it imports value judgements from systems institutionally and economically distinct from the US. GDP-PPP is not a substitute for domestic health economic evaluation. While organisations like ICER demonstrate emerging US capacity for such evaluation, a nationally mandated HTA agency would provide the institutional authority needed to translate this capacity into transparent, outcome-oriented drug pricing under MFN or any successor framework.