PCN51 - Cancer Drugs in The EU5 and USA: Cross-Country Pricing Comparison and Correlation Analysis Between Overall Survival (OS) and Progression-Free Survival (PFS)

Abstract

Overall survival (OS) and progression-free survival (PFS) are commonly used as a surrogate end-point in clinical trials1. This study aims to establish to which extent OS and PFS, considered as sole factors, are correlated to price levels achieved by innovative drugs in EU5 and the US. All 25 cancer drugs (in 40 indications) that received marketing authorization since 2000 were included in the analysis. OS and PFS rates for each product were obtained from summaries of product characteristics. Drug prices were sourced from national pricing databases in May 2016. Individual unit prices were calculated as a price per tablet/vial. Relationship between ex-factory/WAC prices and OS/PFS were tested using multivariate linear regression analysis. Unit prices were regressed as a function of OS and PFS (Yunit price= β0+β1XOS+β2XPFS+ɛ) for each individual country. In Germany, price per unit of cancer drugs were significantly higher than any other European country. The regression analysis shows that on average, an additional month in overall survival could yield an extra €560 per unit in France vs. €564 for one month increase in progression free survival, €723 vs. €693 in Germany, €688 vs.€693 in Spain, €761 vs. €765 in Italy, £502 vs £506 in the UK and $782 vs. $805 in the US. PFS is more positively correlated to price than OS, which suggests payer willingness to pay is higher for PFS than OS. Analyses show that this is even more so the case in the US (correlation coefficient of +14.67). In ceteris paribus, one month increase in PFS is a stronger driver for higher prices for cancer drugs than one month increase in OS in the scope countries. These findings may reflect payers’ preference for PFS over OS and inform pharma clinical development plans.