Do U.S. cancer drug sales reflect clinical benefit? Evidence from solid tumor drugs from 2008 to 2022

OBJECTIVES: To examine whether net sales of solid tumor cancer drugs in the United States are associated with their magnitude of clinical benefit, accounting for orphan status. METHODS: We identified FDA-approved solid tumor cancer drugs (2008-2022) and obtained annual net sales from the SSR Health Database. Clinical benefit was classified using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS). We compared annual sales between drugs with and without substantial clinical benefit using descriptive statistics, event study plots, t-tests, and quantile regression. RESULTS: A total of 243 drug-year observations covering 63 unique indications were included, of which 19 drugs were classified as having a substantial clinical benefit. Average annual net sales were over three times higher for drugs with substantial versus non-substantial clinical benefit (249. 1 million vs. 78. 0 million). The difference was observed for both orphan and non-orphan cancer drugs. CONCLUSIONS: Although prior studies have found little relationship between cancer drug prices and clinical benefit, our findings indicate that net sales, reflecting both price and use, are significantly higher for drugs with substantial clinical benefit. This suggests that the U. S. cancer drug market rewards meaningful innovation through higher market uptake, even in the absence of clear price signals.