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Addressing every need: How the IRA and JCA are changing the landscape for evidence generation and planning

Jan McKendrick, Executive Director and Practice Lead, Global HEOR; Mariam Bibi, Senior Director of Global RWE; Taylor Schwartz, Principal, US Evidence and Strategy; Shalini Parekh, Managing Director, US Market Access; Sarah Feaver, Senior Director Medical Strategy; Orestis Lazos, Associate Director; Adityavir Nat, Marketing Executive | 4/26/2024

Monumental policy changes and evolutions in health technology assessment (HTA) have shifted the evidence-generation landscape for the biopharmaceutical industry. The upcoming and current implementation of policies such as EU regulations on HTA and the US Inflation Reduction Act’s (IRA) Medicare price negotiation provision have signaled the need for a new approach to evidence generation strategy and planning across global markets.

The IRA in the USA and the EU’s new regulation on joint clinical assessment (JCA) each require a shift in the way therapies are commercialized, with biopharmaceutical companies operating in one or both regions navigating a complex environment for evidence planning and generation.

The IRA requires a new approach to evidence generation planning that considers the evidence needed for potential government price negotiations after seven-year or 11-year periods. JCA necessitates a clinical evidence strategy that addresses the needs of all EU member states in a single dossier submission, while also considering the needs of downstream market-specific HTA. These legislative changes call for companies to reassess the life cycle of evidence generation.

We spoke to experts from our Global and US Policy, Access, Value, and Evidence teams, and our Medical team, to understand the effects of these policy changes on evidence generation and planning for the biopharmaceutical and medical technology industry. They highlighted the steps that need to be taken to ensure that evidence generation and assessment are consistently iterated to present demonstrable value and impact across the life cycle of products.

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