Сost-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.

1. Cutaneous and mucosal melanoma. Clinical guidelines. 2023. Available at: https://cr.minzdrav.gov.ru/preview-cr/546_3 (in Russ.) (accessed 15.05.2025).

2. Zhukovets A.G. Current concepts and prospects for skin melanoma management. Oncological Journal. 2015; 9 (4): 69–76 (in Russ.).

3. Kaprin A.D., Starinsky V.V., Shakhzadova A.O. (Eds.) The state of oncological care for the population of Russia in 2025. Мoscow: Herzen Moscow Oncology Research Institute – branch of National Medical Research Radiological Centre; 2025: 275 pp. (in Russ.).

4. Cutaneous and mucosal melanoma. Clinical guidelines. Association of Oncologists of Russia, Association of Specialists in Melanoma Problems, Russian Society of Clinical Oncology. Available at: https://oncology-association.ru/wp-content/uploads/2021/06/melanoma-kozhii-slizistyh-obolochek.pdf (in Russ.) (accessed 15.05.2025).

5. Stroyakovsky D.L., Abramov M.E., Demidov L.V., et al. Practical recommendations for drug treatment of skin melanoma. Malignant Tumors. 2021; 11 (3s2-1): 244–63 (in Russ.). https://doi.org/10.18027/2224-5057-2021-11-3s2-16.

6. Samoylenko I.V., Demidov L.V., Moiseenko F.V., et al. Efficacy and safety of nurulimab + prolgolimab with continued prolgolimab therapy compared to prolgolimab alone as first-line therapy in patients with unresectable or metastatic melanoma: final results of the phase II OBERTON clinical study. Journal of Modern Oncology. 2023; 25 (3): 313–24 (in Russ.). https://doi.org/10.26442/18151434.2023.3.202463.

7. Demidov L., Samoylenko I., Kharkevich G., et al. Proved clinical benefit of low-dose anti-CTLA4 + anti-PD-1 immunotherapy versus mono anti-PD-1 therapy in patients unresectable or metastatic melanoma: Phase III OCTAVA trial. Cancer Res. 2025, 85 (8). https://doi.org/10.1158/1538-7445.AM2025-653.

8. Fedenko A.A., Sedova M.V., Kolomeytseva A.A., et al. Comparative efficacy and safety of prolgolimab + nurulimab and nivolumab + ipilimumab in the first-line therapy of metastatic or unresectable melanoma: a systematic review and matching-adjusted indirect comparison. Journal of Modern Oncology. 2025; 27 (3). https://doi.org/10.26442/18151434.2025.3.203473.

9. General characteristics of the drug Nurulimab + Prolgolimab. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russ.) (accessed 17.04.2025).

10. General characteristics of the drug Prolgolimab. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russ.) (accessed 17.04.2025).

11. General characteristics of the drug Ipilimumab. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russ.) (accessed 17.04.2025).

12. General characteristics of the drug Nivolumab. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russ.) (accessed 17.04.2025).

13. Lebbé C., Meyer N., Mortier L., et al. Evaluation of two dosing regimens for nivolumab in combination with ipilimumab in patients with advanced melanoma: results from the phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019; 37 (11): 867–75. https://doi.org/10.1200/JCO.18.01998.

14. Omelyanovskiy V.V., Avxentyeva M.V., Khachatryan G.R. Methodological recommendations for the use of mathematical modeling in clinical and economic studies and studies using budget impact analysis. Moscow: Center for Healthcare Quality Assessment and Control; 2019: 59 pp. (in Russ.).

15. Wolchok J.D., Chiarion-Sileni V., Gonzalez R., et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017; 377 (14): 1345–56. https://doi.org/10.1056/NEJMoa1709684.

16. Fedenko A.A., Sedova M.V., Batov M.A., et al. Efficacy and safety of first-line prolgolimab and nurulimab versus nivolumab and ipilimumab in advanced or metastatic melanoma: indirect treatment comparison. J Clin Oncol. 2025; 43 (16 Suppl.) https://doi.org/1200/JCO.2025.43.16_suppl.e21517