OBJECTIVES: This study aimed to compare the treatment cost of drugs reimbursed by the Italian NHS and indicated for solid tumors, based on the duration of treatment (DoT) and progression-free survival (PFS).

METHODS: Drugs included in the sample had the last indication reimbursed after 2017 and eventual previous ones after 2010. The treatment cost (Ex-factory) based on DoT was calculated for each drug. The treatment cost was then divided by the months of PFS recorded in the respective clinical trials to obtain a cost per month of PFS, interpreted as the value AIFA gave to that drug. To cluster the analysis and compare the data, PFS and DoT were used as a proxy for disease severity. Two different analyses were performed, considering 4 ranges of DoT and PFS (0-3, 4-6, 7-10 and >10 months).

RESULTS: Analysis of 34 drugs covering 71 different indications showed that treatments within a DoT range of: 0-3 have an average therapy cost per month of PFS of € 8,762; 4-6 have an average therapy cost of PFS of € 6,440; 7-10 have an average therapy cost per month of PFS of € 5,098; >10 have an average therapy cost per month of PFS of € 4,576. Treatments within a PFS range of: 0-3 have an average therapy cost per month of PFS of €8,865; 4-6 have an average therapy cost of PFS of € 6,614; 7-10 have an average therapy cost per month of PFS of € 5,270; >10 have average therapy cost per month of PFS of € 3,992.

CONCLUSIONS: The analysis shows that the treatment cost per month of PFS, reimbursed by the Italian NHS, increases as DoT/PFS values decrease and, therefore, correlating with the proxy of disease severity. These variables are therefore informative in determining the benchmark price, even without considering unmet need and added value.