MarketingMedicalPolicy,Access,Value, andEvidenceConsultingData,Technology,and Media
murmuration of birds

thought leadership

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.

Fill in the form below to receive the full article. 

We care about your privacy

By clicking "Accept all cookies", you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.

Manage my preferences

How we use cookies

Cookies are files saved on your phone, tablet or computer when you visit a website.

We use cookies to store information about how you use the Avalere Health website, such as the pages you visit.

For more information, check the cookie statement


Cookie settings

We use 4 types of cookies. You can choose which cookies you're happy for us to use.

Cookies that measure website use.

We use Google Analytics to measure how you use the website so we can improve it based on user needs. We do not allow Google to use or share the data about how you use this site.

  • how you got to the site
  • the pages you visit on, and how long you spend on each page
  • what you click on while you're visiting the site

Cookies that help with our communications and marketing

These cookies may be set by third party websites and do things like measure how you view Vimeo videos that are on

Cookies that remember your settings

These cookies do things like remember your preferences and the choices you make, to personalize your experience of using the site.

Strictly necessary cookies

These essential cookies do things like remember your progress through a form (eg. Registering for new content alerts).

These cookies always need to be on.