VIDEO: Toward a US HTA? Examining the IRA’s emerging role

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program (DPNP) has introduced a new pricing mechanism in the US – one that closely resembles established health technology assessment (HTA) processes. With its focus on clinical evidence, economic data, and real-world evidence (RWE), the IRA raises a critical question: is it evolving into a de-facto HTA body? And what are the implications for the commercial lifecycle of branded medicines?

At ISPOR 2025, Priti Jhingran and Tijana Ignjatovic from Genesis Research Group explored this topic in their session, “Is IRA Becoming America’s HTA?”. In this interview, we speak with Priti and Tijana to dive deeper into their insights and discuss what the IRA might mean for future pricing and access strategies.

You can view the entire video or view a specific question by entering ‘Fullscreen’ or navigate via the ‘Visual Table of Contents’.

Questions:

• 0:00: Introduction
• 0:10: To begin, could you briefly describe your roles at Genesis Research and what led you to explore this topic at ISPOR 2025?
• 2:33: Priti, can you outline the key evidence requirements under the IRA’s Medicare Drug Price Negotiation Program (DPNP)?
• 4:02: In your view, which elements of the IRA negotiation process most closely resemble traditional HTA frameworks? And conversely, where do they diverge?
• 6:45: One notable distinction is the exclusion of QALYs in IRA negotiations. How does this influence the nature and quality of evidence that manufacturers are expected to submit?
• 7:39: Tijana, your analysis suggests that the IRA may shorten the free-pricing window by approximately two years. What are the implications of this for early pricing and market access strategies, particularly for small-molecule therapies?
• 10:08: The requirement to apply a single Maximum Fair Price (MFP) across all indications presents challenges for multi-indication and combination products. How can manufacturers strategically address this when considering label expansions?
• 11:45: Reflecting on the first round of negotiations, which types of evidence appeared most influential in determining outcomes? And which elements had less impact than expected?
• 14:02: Looking ahead, what practical advice would you offer to manufacturers and HEOR teams preparing for the next negotiation cycle? Are there specific “IRA-readiness” strategies you would emphasize?
• 15:00: Finally, how do you see the role of RWE evolving in future IRA negotiations, especially given the emphasis on post-launch evidence?

ACCESS A RECORDING OF THE ORIGINAL ISPOR 2025 PRESENTATION HERE

Priti Jhingran
Vice President, Evidence & HEOR Strategy
Genesis Research Group, US 

With over three decades of experience working in the pharmaceutical industry, Dr Jhingran has focused her efforts to understand evidence needs and deliver tools/solutions, such as economic models and objection handlers, for access decision-makers/HTAs in US and exUS markets. She has facilitated and led multiple enterprise level initiatives focused on value, evidence, and outcomes. She brings extensive launch support experience with 15+ pharmaceutical product launches in key markets. Dr Jhingran has led, managed, and developed diverse teams of health outcomes scientists dedicated to generation, dissemination, and communication of evidence supporting optimal reimbursement/access decisions for pharmaceutical products. She has published in the areas of health economic evaluation, health policy, and health services research with over 75 peer-reviewed populations.

Tijana Ignjatovic
Vice President, Global Market Access & Pricing
Genesis Research Group, UK

Tijana Ignjatovic has over 16 years of consultancy experience within market access, having conducted well over 100 pieces of research across a range of therapy areas. This experience has given Tijana in-depth knowledge on how to optimize research methodologies to meet the strategic intent of payer research and provide actionable recommendations.

Disclosures:

The opinions expressed in this feature are those of the author and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.

Sponsorship for this Interview was provided by  Genesis Research Group