The IRA May Have Unintended Consequences on Subsequent Indications of Oncology Drugs (New Research)

Updated 5:00 PM ET, October 15, 2024

Contact: Michael Pratt, 202-827-2088, [email protected]

Washington, D.C. – Oncology drugs follow common, yet distinct, pathways of ongoing development for subsequent indications. Changes to the incentives for drug development due to the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (DPNP) hold potential unintended consequences for post-approval research and development. A gap remains, however, in understanding drug-level post-approval development in cancer drugs. 

New research from the National Pharmaceutical Council published in Therapeutic Innovation & Regulatory Science, “Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act,” provides additional drug-level insights about development pathways and the potential impact of the IRA DPNP. The study was authored by Julie A. Patterson, PharmD, PhD; James Motyka, PharmD; Rayan Salih, PharmD; Robert Nordyke, PhD, MS; John M. O’Brien, PharmD, MPH; and Jonathan D. Campbell, PhD, MS. This cross-sectional study evaluated 86 oncology drugs first approved by the FDA from 2008 to 2018 — 56 (65.1%) of which were later approved for one or more additional indications.

This study is unique because it captures drug-level trajectories toward subsequent indications. Overall, a quarter of these 56 drugs were approved for their most recent subsequent indication after the time at which the drug would be eligible for the price-setting process through the DPNP.

Subsequent indications are not simply “me-too” indications. Among the drugs studied:

• 61% of these drugs had at least one subsequent indication for an additional cancer type;
• Half of these drugs had at least one subsequent indication for a new line of treatment – nearly all moved from later lines to earlier lines;
• 41% had at least one subsequent indication for a new combination; 32% for a new mutation, and over 28% for a new stage.

“We wanted to know more about drug-level details – as opposed to indication-level details – for oncology medicines as they move toward subsequent indications,” said lead author Dr. Patterson, NPC Senior Director of Research. “In addition to supporting concerns about the impact of the IRA’s price-setting “clock” on subsequent indications, our research found almost two-thirds of these drugs expanded treatment options for additional cancer types.”

The heterogeneity of those development pathways for oncology drugs will be impacted in different ways by the IRA DPNP.

Drugs with the most rapid pace of development often received their first subsequent indication approval within 9 months of initial approval, placing them at the most risk of delayed launches given the changing incentives of the law.

Drugs with more measured development timelines, disproportionately small molecule drugs, often received FDA approvals for later subsequent indications more than 7 years after initial approval, suggesting this group of cancer drugs may be most at risk of changing incentives surrounding subsequent indications under the IRA.

“Drug development is not one size fits all, particularly in cancer, where the same drug often benefits patients who are living with different mutations or cancers,” said Dr. Campbell, NPC Chief Science Officer. “This study informs important discussions about how the IRA changes incentives for oncology drugs following different development trajectories – adding to the evidence for policymakers to consider about the unintended consequences of the DPNP.”

The study also found that small molecule oncology drugs had more measured development than biologic drugs:

• Biologic oncology drugs may be more likely to be impacted by changing incentives toward delayed launches.
• Small molecule oncology drugs may be more likely to encounter disincentives for the development of subsequent indications approved longer after a drug is first approved.

Read the research: “Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act.”

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About the National Pharmaceutical Council 

The National Pharmaceutical Council (NPC) is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation's major research-based pharmaceutical companies, NPC focuses on research development, information dissemination and education on the critical issues of evidence, innovation, and the value of medicines for patients. For more information, visit www.npcnow.org and follow NPC on LinkedIn.