Following last year’s ISPOR, we knew there was mounting uncertainty in the US healthcare landscape and set out to sort through the known and unknown. This year, the only certainty provided was the fact that uncertainty is only sure to grow over the coming years. From GLOBE to GUARD, MFN to MFP, 340B to ASP, and the rest of the alphabet soup in between, the overlapping programs and policies proposed in the last 15 months promise to prolong the ambiguity and complexity in the US market.
While Inflation Reduction Act (IRA) negotiations have started to stabilise, with manufacturers accepting it as the norm, several other policies are changing the calculus for drugmakers:1
Mandatory Medicare programs to link Part B and Part D drugs, respectively, to international reference prices
Voluntary Medicaid program capturing outpatient drugs in the Medicaid Drug Rebate Program and linking prices to the second lowest price paid from a basket of eight countries
“Voluntary” policies developed through executive order to require manufacturers to make existing drugs available to state Medicaid programs at MFN prices. Notably, manufacturers that agree to MFN deals (or other manufacturing/access agreements with the federal government) can be exempt from potential tariffs on their products
For products already on the market, manufacturers must now choose how to re-price drugs to fit within these frameworks. For drugs that have yet to be launched, it can throw entire launch strategies into disarray.
Simultaneously, pricing has been joined by another key concern: access. Increased use of prior authorisation and utilisation management is creating imbalances between approval and patient access. Rising initial denial rates, expanded step therapy requirements, and more complex coverage criteria mean favourable pricing does not guarantee patients will receive treatment. For both providers and patients, access delays and associated administrative burden are becoming central features of the treatment journey. These concerns are compounded by the role of intermediaries, with pharmacy benefit managers continuing to influence access through formulary exclusions and rebate structures, often diluting the intended impact of list price reforms. In response, new distribution models, including direct-to-consumer approaches, are increasingly emerging as greater control over pricing and access is sought.2
Early signs of adaptation are emerging across the industry. Manufacturers are reassessing launch preparations in response to pricing reforms, particularly MFN, and access constraints. While last year’s conference focused on understanding MFN after its announcement, this year centred on its likely effects on innovation and access in the US and globally (see MFN Through the Lens of Dynamic Efficiency article).
Overall, discussions consistently highlighted that the US healthcare system places a strong emphasis on supporting innovation alongside improving patient outcomes. As reforms continue, especially with MFN, protecting both access and incentives for innovation will be essential, with clear implications for launch sequencing and pricing strategy to ensure products address unmet needs while remaining competitive and accessible in this evolving landscape.
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If you would like any further information on the summary presented above, please get in touch, or visit our Value & Access page to learn how our expertise can benefit you. Aaditya Rawal (Consultant) and Julia Eustace (Senior Analyst), created this article on behalf of Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients or affiliated partners.
