Dinutuximab BetaVersus Naxitamab in the Treatment of Relapsed/Refractory Neuroblastoma - Matching-Adjusted Indirect Treatment Comparison and Economic Evaluation in Mexico
Moderator
Helder Paiva
Speakers
Przemyslaw Holko, PhD; Katarzyna Sladowska, PhD; Pawel Kawalec, PhD, MD, Jagiellonian University, Kraków, Poland; Juan Carlos Sánchez-Salgado
OBJECTIVES: No head-to-head trials comparing anti-GD2 antibodies dinutuximab beta (DB) and naxitamab (NAX) in the treatment of relapsed/refractory neuroblastoma (NB) have been conducted. We aimed to indirectly compare efficacy and cost-effectiveness of these therapies.
METHODS: Systematic literature review was conducted to identify evidence for matching-adjusted indirect comparison (MAIC). Individual patient data (IPD) from DB trials matching NAX licensed population were included and adjusted for predictors of outcomes: MYCN-A, relapsed versus refractory disease, and sex. Semi-Markov cost-effectiveness model was built based on parametric fits to progression free survival (PFS) data with overall survival estimated from time from progression to death using IPD. Frequency of grade 3+ adverse events was assumed to be comparable. Dosing of DB and NAX was based on clinical trial regimens. Half of the patients were assumed to be treated equally likely with one of the anti-GD2 immunotherapies following subsequent relapse. Mexico public healthcare costs and 2025 drug list prices were used. Utilities obtained from literature and costs were discounted at 5% over lifetime horizon.
RESULTS: Aggregated NAX data from Study 201 (N=52) and individual patient data from DB Studies APN311-304 and APN311-202 (N=77) met the inclusion criteria. Compared to NAX, DB significantly improved PFS (HR=0.48, 95% CI: 0.28; 0.83, p=0.009) with 2.87 additional years (95% CI: 1.39; 4.33) and 2.68 additional QALYs. NAX was 9,794,964 MXP more costly and was dominated by DB. Results were most sensitive to prices of anti-GD2 therapies and number of cycles of NAX. With NAX use restricted to 6 cycles, cost saving was 3,309,400 MXP. In a sensitivity analysis with subsequent relapse not treated with anti-GD2 immunotherapy the cost saving with DB was 9,020,372 MXP.
CONCLUSIONS: Compared to naxitamab, dinutuximab beta improves survival in patients with relapsed/refractory neuroblastoma and is cost-saving in the health care system in Mexico.
METHODS: Systematic literature review was conducted to identify evidence for matching-adjusted indirect comparison (MAIC). Individual patient data (IPD) from DB trials matching NAX licensed population were included and adjusted for predictors of outcomes: MYCN-A, relapsed versus refractory disease, and sex. Semi-Markov cost-effectiveness model was built based on parametric fits to progression free survival (PFS) data with overall survival estimated from time from progression to death using IPD. Frequency of grade 3+ adverse events was assumed to be comparable. Dosing of DB and NAX was based on clinical trial regimens. Half of the patients were assumed to be treated equally likely with one of the anti-GD2 immunotherapies following subsequent relapse. Mexico public healthcare costs and 2025 drug list prices were used. Utilities obtained from literature and costs were discounted at 5% over lifetime horizon.
RESULTS: Aggregated NAX data from Study 201 (N=52) and individual patient data from DB Studies APN311-304 and APN311-202 (N=77) met the inclusion criteria. Compared to NAX, DB significantly improved PFS (HR=0.48, 95% CI: 0.28; 0.83, p=0.009) with 2.87 additional years (95% CI: 1.39; 4.33) and 2.68 additional QALYs. NAX was 9,794,964 MXP more costly and was dominated by DB. Results were most sensitive to prices of anti-GD2 therapies and number of cycles of NAX. With NAX use restricted to 6 cycles, cost saving was 3,309,400 MXP. In a sensitivity analysis with subsequent relapse not treated with anti-GD2 immunotherapy the cost saving with DB was 9,020,372 MXP.
CONCLUSIONS: Compared to naxitamab, dinutuximab beta improves survival in patients with relapsed/refractory neuroblastoma and is cost-saving in the health care system in Mexico.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE144
Topic
Economic Evaluation
Disease
SDC: Oncology, SDC: Pediatrics, SDC: Rare & Orphan Diseases