Abstract 1753P
Background
NIVO is the first immuno-oncology drug to demonstrate significantly improved disease-free (DF) survival for the adjuvant treatment of patients (pts) with MIUC-HR who had undergone radical resection, compared to placebo (PBO). The objective of this study was to assess the CE of NIVO versus surveillance (SURV), a proxy of PBO, in this indication in France.
Methods
A 4-state (DF, local recurrence (LR), distant recurrence (DR), death) semi-Markov model was used to conduct an analysis from the French healthcare system perspective, over a 25 years (yrs) time horizon with a one-week cycle length. The population included in this analysis was MIUC-HR pts who had undergone radical resection, with tumor cell PD-L1 expression ≥1%, who received either NIVO or surveillance (SURV). Costs (€, cost yr: 2021, French specific) and effects were discounted by 2.5% annually. Patient characteristics, efficacy, safety and utilities (EQ-5D-3L) were derived from the CheckMate 274 trial (NCT02632409) or the literature. Health-state specific utilities were calculated using the French value set. Outcomes of interest were life years (LYs), quality adjusted LYs (QALYs), and incremental cost-utility ratio (ICUR). Deterministic and probabilistic sensitivity analyses (DSA and PSA, respectively) and different scenarios (on modelling assumptions or type care) were conducted to quantify uncertainty.
Results
Over 25 yrs, NIVO was associated with higher total LYs and QALYs and increased costs (9.3, 6.0, and €128,345) vs SURV (6.4, 3.9 and €77,259), all respectively. Most LYs and QALYs were observed in the DF health state for both NIVO and SURV. This resulted in an ICUR of €25,565/QALY gained. All tested scenarios and inputs in the DSA resulted in less than 20% changes from the base case ICUR. The PSA confirmed robustness of the model results, with NIVO having a 97% probability of being cost-effective at a willingness to pay (WTP) threshold of €50,000/QALY gained.
Conclusions
In a disease setting with high unmet medical need, NIVO as adjuvant treatment appears to be a cost-effective strategy at a WTP threshold of €50,000/QALY gained in the French context with limited uncertainty around this result.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
M.S. Negrier: Financial Interests, Institutional, Research Grant: Pfizer, Ipsen; Financial Interests, Personal, Other, Personnal fees: Pfizer, BMS; Non-Financial Interests, Institutional, Other, Non-Financial Support: Pfizer; Non-Financial Interests, Institutional, Other, non-financial support: BMS, Ipsen; Financial Interests, Personal, Other, Personal fees: Ipsen, Novartis, MSD, Eisai; Non-Financial Interests, Institutional, Other, Non-financial support: Novartis, MSD, Eisai. F.P. Colrat: Financial Interests, Personal, Member, Employee of BMS: BMS. J. Bonastre: Financial Interests, Personal, Advisory Board, Health economic board in bladder cancer: BMS; Financial Interests, Institutional, Funding, Funding of the MICADO study: BMS. C. Chamielec: Financial Interests, Institutional, Other, Vyoo Agency is a French vendor involved in the study presented in this abstract: BMS. S. Teitsson: Financial Interests, Personal, Member, Employee of BMS: BMS. C. Knight: Financial Interests, Institutional, Other, RTI is a vendor involved in the study presented in this abstract: BMS. L. Ni: Financial Interests, Institutional, Other, RTI is a vendor involved in the study presented in this abstract: BMS. J. Chevalier: Financial Interests, Institutional, Other, Vyoo Agency is a French vendor involved in the study presented in this abstract: BMS. A. Gaudin: Financial Interests, Personal, Member, Employee of BMS: BMS. M. Roupret: Financial Interests, Personal, Advisory Board: BMS, Roche, AstraZeneca, Janssen, Astellas. S. Branchoux: Financial Interests, Personal, Member, Employee of BMS: BMS.