Abstract
BACKGROUND: Immune checkpoint inhibitors (ICIs) treatment is a breakthrough in managing metastatic solid tumours, but its use is associated with a high financial burden for public health care systems. Validated tools such as the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) are frameworks that might help to better assess the clinical benefit of these novel innovative cancer drugs. METHODS: Here, we systematically analysed the number of European Medicines Agency-approved ICIs labels with an ESMO-MCBS grade <4 and the impact of the ICIs on incremental costs, gain of life years (LYs), quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio in the Austrian population. RESULTS: Of 23 ICIs treatment settings, we identified three clinical scenarios in metastatic solid cancers with an ESMO-MCBS grade <4 with no otherwise approved alternatives. In triple-negative breast cancer (TNBC), the addition of first-line atezolizumab increased QALYs by 0.33 compared with nab-paclitaxel only, with an incremental cost per QALY of €143 853. In small-cell lung cancer (SCLC), the addition of first-line atezolizumab increased the QALY by 0.09, with an incremental cost per QALY of €373 256, and the addition of first-line durvalumab increased the QALYs by 0.11, with an incremental cost per QALY of €589 527. CONCLUSIONS: Overall, most of the approved ICIs carry significant clinical benefit (≥4). Although TNBC and SCLC are challenging treatment scenarios, currently approved ICIs with an ESMO-MCBS grade <4 substantially increase the cost of medical treatment, and under a willingness-to-pay threshold of €100 000, they do not have a cost-effective comparative benefit.