Nivolumab Is a Cost-Effective Second-Line Treatment for Metastatic Renal-Cell Carcinoma.

Abstract

The introduction of active new agents, such as small molecules and checkpoint inhibitors, for the treatment of metastatic renal-cell cancer (mRCC) is associated with a relevant increase in costs, and it is therefore important to strike a balance between the costs of treatment and the added value represented by the improvement of the clinical parameters of interest such as progression-free survival (PFS) and overall survival (OS). This analysis was conducted to assess the pharmacologic costs of second-line treatments for mRCC and was restricted to pivotal phase 3 randomized controlled trials (RCTs) used as second-line therapy. Our analysis evaluated 4 phase 3 RCTs including a total of 2454 patients. The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) reached high scores (grade 5) for the CheckMate 025 trial, medium scores (grade 3) for the RECORD-1 and AXIS trials, and low scores (grade 2) for the INTORSECT trial. When we combined the costs of therapy with the measure of efficacy represented by the PFS and OS, we found that the most relevant increase of costs was associated with the use of nivolumab but that it differed according to the difference in costs in terms of life gained, with the highest costs per week of PFS gained (€11,960) but the lowest cost for month of OS gain (€1772). When pharmacologic costs of drugs are combined with the measure of efficacy represented by the OS, nivolumab is a cost-effective second-line treatment for patients with mRCC.