Riflessioni sulla determinazione del valore dei farmaci oncologici: un’analisi sui farmaci di prima linea per i tumori metastatici

Some considerations about the value based pricing in oncology: an analysis on metastatic first line medicinal products. Introduction: In recent years public health systems have faced the challenge of ensuring sustainable costs for inno-vative medicinal products. The aim of this study is to analyse pricing behaviour applied in the Italian oncology sector. Methods: The study examined all new oncologic compounds that are reimbursed in Italy, for utilization in the first-line metastatic setting. A regression model was developed to analyse the relation between drug price, clini-cal benefit, market potential and the year in which reimbursement was granted in Italy. The clinical benefit was measured by increment in Overall Survival respect to standard of care; two different metrics were considered, namely median and mean. Results: The analysis revealed a strong correlation between price and clinical benefit and a weak negative correla-tion between prices and volumes; no time trends were observed in reimbursement price reduction. As regards pricing, the Italian Medicines Agency seems to have maintained basically consistent reference levels over the 10 years. Nevertheless, the analysis highlighted significant differences: some compounds showed lower prices than expected; conversely, vemurafenib, sunitinib and, to a much lesser degree, pazopanib prices were higher than expected. The only drug for which price evaluation is inverted depending on whether median or mean val-ues are used is ipilimumab, the only immunotherapeutic compound considered. Discussion: The study highlights the extent to which the value of oncological drugs depends on the endpoints considered in the analysis, as well as on the metric adopted, , confirming that the decision must be multidimen-sional, as required by an Health Technology Assessment rationale