Cost-effectiveness analysis of nurulimab and prolgolimab combination used in adult patients with unresectable or metastatic cutaneous melanoma

Objective: To conduct a cost-effectiveness analysis of first-line treatment regimens based on nurulimab + prolgolimab combination in comparison with ipilimumab + nivolumab combination among adult patients in the Russian Federation with unresectable or metastatic cutaneous melanoma (CM). Material and methods. An adjusted indirect comparison of the efficacy of nurulimab + prolgolimab combination and ipilimumab + nivolumab combination in both dose regimens was conducted according to data from BCD-217-2/OCTAVA and CheckMate 511 randomized controlled trials, respectively. Only direct medical costs for the first-line immunotherapy of unresectable or metastatic CM were taken into account, i.e. manufacture prices with 10% value-added tax and 5% discount rate. The cost-effectiveness analysis was based on estimation of cost per life years gained (LYG) and patient life preservation for a period from 1 to 5 years. Sensitivity analysis was used to assess the impact of price fluctuations on the study results. Results. The total direct costs over 5-year horizon for the nurulimab + prolgolimab combination were 19% lower than that for the ipilimumab 3 mg/kg + nivolumab 1 mg/kg combination, and nurulimab + prolgolimab costs were comparable with the ipilimumab 1 mg/kg + nivolumab 3 mg/kg combination. At the same time, the cost per 1 LYG for the nurulimab + prolgolimab combination therapy turned out to be minimal, amounting to 3.07 million rubles versus 3.44–4.21 million rubles for ipilimumab + nivolumab combinations. In addition, cost per patient life preservation for the nurulimab + prolgolimab combination was lower than that for the ipilimumab 3 mg/kg + nivolumab 1 mg/kg therapy in the first year by 0.7 million rubles (10%), with this difference amounting to 9.1 million rubles (49%) by the fifth year. In comparison with the combination of nurulimab + prolgolimab, the costs for the ipilimumab 1 mg/kg + nivolumab 3 mg/kg combination required to reach patient life preservation in the first year was lower by 1.5 million rubles (20%), although increasing by 4.1 million rubles (23%) vs nurulimab + prolgolimab costs by the fifth year of therapy. Conclusion. Widespread introduction of the nurulimab + prolgolimab combination for unresectable or metastatic CM into current clinical practice will increase patient survival and will contribute to achieving the target indicators of the Russian Ministry of Health in terms of reducing one-year mortality and increasing the proportion of patients with malignant neoplasms registered for 5 or more years. This effect can be achieved in the setting of lower or comparable costs of treatment, which allows improved cost-effectiveness to be achieved when applying the prolgolimab + nurulimab combination.