Anticancer Drug Prices and Clinical Outcomes: A cross-sectional study in Italy.

In Italy, drug-pricing negotiations based on cost effectiveness evaluations have been mandatory since 2001. Starting 2006, the country introduced performance-based risk-sharing arrangements. 

Has the Italian approach led to a better alignment of prices and value?

This new paper is the first attempt at evaluating whether there is any correlation between drug prices (focusing on cancer products) and clinical outcomes in a setting where central price negotiations are mandatory for every new medicine.

All new anti-cancer drugs approved by the EMA between 2010 – 2016 and reimbursed in Italy were included in the analysis - 30 new anticancer drugs (with 35 indications). Clinical outcomes were defined as median overall survival (OS), median progression-free survival (PFS) and objective response rate (ORR).

The study observed no correlation between improvement in (any) clinical outcomes and negotiated prices across any of the 30 reimbursed products.

It appears there is little-to-no relationship between the cost of cancer drugs and their respective therapeutic benefits in Italy. More importantly, the country's mandatory pricing negotiations - a strategy that has been followed in Italy for years - has offered little success.