Cost-Effectiveness Evaluation of Oncological Drugs Newly Marketed in Italy

Abstract

In a previous publication, the incremental overall survival (OS gain vs current therapy) was estimated for the 32 new cancer therapies authorized in Italy between 2010 and 2013. The objective of this article was to quantify the respective incremental costs (including possible regulatory agreements) in order to build incremental cost-effectiveness ratios (ICERs) to be used for economic evaluation. In a first group of 12 therapies, where OS gains were statistically significant (p < 0.05), the ICERs' median value was €53,273 per year gained (range: 3,945 - 179,098) and the mean value was €64,181 (95% CI: 29,302 - 99,060). In the other group, excluding four therapies with negative OS gains, ICERs were calculated for the remaining 16 drugs. The median ICER resulted in €69,568 (range: 3,406 - 308,928) and the mean value was €87,330 (95% CI: 37,024 - 137,636). Assuming a threshold of €5,000 per life-month gained, a total of 14 new cancer therapies met this criterion of economic acceptability (eight out of 12 in the first group and six out of 20 in the second). However, there is consensus among health authorities that the particular nature of such therapies should be kept into account, so that higher threshold values might be adopted.