Postapproval Innovation For Oncology Drugs And The Inflation Reduction Act

The Inflation Reduction Act's Drug Price Negotiation Program (DPNP) will affect incentives for biopharmaceutical investment by reducing prices and expected profits. Discussion has focused on the program's potential impact on the number of new drugs, but postapproval activity, which is common in oncology, will also be affected. If the history we describe is representative, postapproval exposure to DPNP eligibility dates would be high for oncology drugs. For 155 oncology drugs approved during the period 2000-21 (112 small molecules and 43 biologics), 57 percent of labeled indications approved by the Food and Drug Administration and 68 percent of industry-sponsored clinical trials occurred postapproval, often near or after DPNP selection dates. Compared with biologics, exposure to DPNP eligibility dates is more than twice as high for small molecules; although expected durations from drug approval to trial end are shorter, DPNP eligibility dates occur much sooner. Areas of potential postapproval impact include additional tumor types; rare diseases, particularly for drugs with multiple orphan indications; and pediatric indications, of which two-thirds occurred postapproval.