Author(s)
Polanco Sánchez C1, Pérez-Alcántara F2, May J3, Gooden KM4, Malcolm B5, Arranz JA6, Duran I7, García-Donas J8, Gallardo E9, Láinez N10, Maroto P11, Valderrama BP12, Puente J13, Vázquez S14, Van de Wetering G15, Smith van Carroll LE16
1Bristol-Myers Squibb, Madrid, M, Spain, 2Oblikue Consulting, Barcelona, Spain, 3Bristol-Myers Squibb, Uxbridge, UK, 4Bristol-Myers Squibb, Lawrenceville, NJ, USA, 5Bristol-Myers Squibb, Middlesex, UK, 6Hospital General Universitario Gregorio Marañón, Madrid, Spain, 7Hospital Universitario Marqués de Valdecilla, Santander, Spain, 8Centro Integral Oncológico Clara Campal - HM CIOCC, Madrid, Spain, 9Parc Taulí Hospital Universitari, Sabadell, Spain, 10Complejo Hospitalario de Navarra, Pamplona, Spain, 11Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 12Hospital Universitario Virgen del Rocío, Sevilla, Spain, 13Hospital Clínico San Carlos, Madrid, Spain, 14Hospital Universitario Lucus Augusti, Lugo, Spain, 15Pharmerit International, Rotterdam, Netherlands, 16Pharmerit International, York, NYK, UK
OBJECTIVES: Nivolumab plus ipilimumab (nivolumab+ipilimumab) is the first immuno-oncology combination that has shown significant, long-term overall survival (OS) benefit for the first-line treatment of adult patients with intermediate- or poor-risk advanced renal cell carcinoma (1L RCC) compared with standard of care (sunitinib). This study assessed the cost-effectiveness of nivolumab+ipilimumab versus sunitinib in 1L RCC patients in Spain. METHODS: A three-state partitioned survival model was developed (progression-free, progressed disease and death) with a lifetime horizon (40 years) and one-week cycle length. Progression-free survival, OS, time to treatment discontinuation, adverse event and treatment-specific utility data (EQ-5D-3L) was obtained from CheckMate-214 (NCT02231749; 30 months minimum follow-up). Spanish costs for adverse events and drug acquisition were obtained from Isla (2017) and CGCOF, respectively. Costs for drug administration, monitoring and subsequent therapies were taken from ESALUD (2018); associated resource use was based on CheckMate-214 and obtained through clinical expert input. An annual discount of 3.0% was applied to both costs and outcomes. Outcomes of interest were total costs, life years (LYs), quality-adjusted life-years (QALYs), and the incremental cost-utility ratio (ICUR). Furthermore, deterministic and probabilistic sensitivity analyses (DSA and PSA) were assessed for robustness of the results. RESULTS: Nivolumab+ipilimumab was associated with higher QALYs versus sunitinib (4.86 versus 3.54, respectively) at increased total cost (€142,450 versus €104,085, respectively). This resulted in an ICUR of €29,146/QALY versus sunitinib. Based on the DSA, the key ICUR drivers were the proportion of patients receiving treatment after sunitinib and the maximum treatment duration for nivolumab+ipilimumab. The model’s robustness was further confirmed by the PSA; nivolumab+ipilimumab had a 54% and 95% probability of being cost-effective at willingness-to-pay thresholds of €30,000/QALY and €50,000/QALY, respectively. CONCLUSIONS: Driven by the increased and sustained OS benefit demonstrated in CheckMate-214, nivolumab+ipilimumab is a cost-effective treatment when compared to sunitinib for 1L RCC patients in Spain, considering a willingness-to-pay of €30,000/QALY.
