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John O’Brien: Drug-level insights about development pathways for Cancer Treatments

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Oct 23, 2024, 19:55

John O’Brien: Drug-level insights about development pathways for Cancer Treatments

John O’Brien, President and CEO of the National Pharmaceutical Council, shared a post on LinkedIn about a paper by Julie Patterson al. published in Springer Link:

“New research from the National Pharmaceutical Council published in Therapeutic Innovation and Regulatory Science provides drug-level insights about development pathways for Cancer Treatments and the potential impact of the IRA’s Medicare Drug Price Negotiation Program.

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.

The research is unique because it captures drug-level trajectories toward subsequent indications. Here’s what we found.

1. 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.

2. 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.

3. 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.”

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

Authors: Julie Patterson, James Motyka, Rayan Salih, Robert Nordyke, John O’Brien, Jonathan Campbell.

John O'Brien: Drug-level insights about development pathways for Cancer Treatments

John O’Brien is the President and CEO of the National Pharmaceutical Council. He also serves as a board member for Circles and The John F. Kennedy Center for the Performing Arts. Previously, he held senior positions at the U.S. Department of Health and Human Services, including Senior Advisor to the Secretary. O’Brien was also Vice President of Public Policy at CareFirst BlueCross BlueShield.