Nivolumab, an anti-PD-1 inhibitor, has been approved in France in treatment of first-line BRAF wild-type advanced melanoma and of advanced non-small cell lung cancer after platinum-based chemotherapy, with an approximate monthly processing cost of €5,550 per patient. The objective of our study was to evaluate efficacy and correct use of anti-PD1 antibodies in daily practice since its approvals.
This retrospective study was conducted between July 2015 and December 2016 on 62 patient files at the Pitié-Salpêtrière hospital, using patient medical records and Multidisciplinary Medical Board (MMB) software. According to the Summary of Product Characteristics (SPC), the correct use of nivolumab required compliance with indications, a WHO status
Sixty patients were treated for lung cancer: 38 patients (62%) with adenocarcinoma, 14 (22%) with squamous cell carcinoma and 8 (13%) with large cell lung cancer. At the cut-off analysis, 28 patients (47%) had a progressive disease, 20 (32%) were still receiving treatment and 41(65%) were still alive, with a median follow-up of 6.5 months (0,3 to 17.7 months). Thirteen patients received more than 10 injections and 13 received less than 5 injections. The correct use of nivolumab was observed in 45 patients (73%), 12 patients had a WHO status of 2, 1 patient had a WHO status of 3, and 4 patients received concomitant corticosteroids. The poor utilization of treatment for these 17 patients (27%) totaled 149 injections, costing about €410,000 for a total of €1,615,000 of expenditures using this treatment. Survival rates were not statistically different in these patients compared to those respecting SPC criteria (53% versus 70%; p = 0.2).
Although a high cost of inappropriate use of nivolumab, there was no significant difference in survival rates in these patients. These preliminary findings highlight the differences between study populations and daily practice, reflecting willingness of practitioners to give patients access to innovative treatments. Cost effectiveness and efficacy/tolerance data will be updated at the meeting presentation to better determine treatment criteria in daily practice.
Clinical trial identification
Legal entity responsible for the study
Assistance Publique - Hôpitaux de Paris
J-P. Spano: Received fees and has been member of advisory board of Bristol-Myers Squibb, MSD and Roche. All other authors have declared no conflicts of interest.