Postapproval Innovation For Oncology Drugs And The Inflation Reduction Act.

Area of Science:

• Pharmaceuticals
• Health Policy
• Oncology

Background:

• The Inflation Reduction Act's Drug Price Negotiation Program (DPNP) aims to lower prescription drug costs.
• This program may impact biopharmaceutical investment by altering expected profits and drug pricing.
• Focus has been on new drug development, but postapproval activities are also a concern, especially in oncology.

Purpose of the Study:

• To assess the potential impact of the DPNP on postapproval activities for oncology drugs.
• To quantify the exposure of oncology drugs to DPNP eligibility dates post-FDA approval.

Main Methods:

• Analysis of 155 oncology drugs approved between 2000-2021 (112 small molecules, 43 biologics).
• Examination of Food and Drug Administration (FDA)-approved labeled indications and industry-sponsored clinical trials.
• Comparison of postapproval exposure to DPNP eligibility dates for small molecules versus biologics.

Main Results:

• 57% of labeled indications and 68% of clinical trials occurred postapproval for oncology drugs.
• Postapproval activities frequently occurred near or after DPNP selection eligibility dates.
• Small molecule oncology drugs face more than double the exposure to DPNP eligibility dates compared to biologics.

Conclusions:

• Oncology drugs, particularly small molecules, show substantial postapproval activity that could be affected by DPNP.
• Potential impacts include changes to the development of additional tumor types, rare disease treatments, and pediatric indications.
• The DPNP may significantly alter postapproval investment incentives in the biopharmaceutical sector for oncology drugs.