Drug Provision for Patients with Cutaneous Melanoma in Outpatient Settings: Regional Experience

INTRODUCTION. Despite its relatively low share in the structure of oncological incidence, cutaneous melanoma (CM) is one of the most cost-intensive nosologies. The emerging new combination treatment regimens require regular pharmacoeconomic monitoring.

AIM. This study aimed to evaluate the current structure, dynamics, and costs of drug therapy in Moscow region over 2020–2022 based on pharmacoepidemiological and pharmacoeconomic analysis of subsidised drug provision in order to identify key regional trends.

MATERIALS AND METHODS. Primary depersonalised data were obtained from patient medical records in the Unified Medical Information and Analytical System (EMIAS). The analysis included total number of patients and their clinical profile (gender, age, diagnosis code); for the drugs, international non-proprietary name, dosage form, dosage, number of packages sold, and total cost was analysed. Cost analysis considered both total cost and structure in terms of selected international non-proprietary names. An additional analysis was conducted for a three-year period.

RESULTS. Data from 1,522 patients diagnosed with ICD-10 C43.0–43.9 were examined (465 patients in 2020, 526 patients in 2021, and 531 patients in 2022). Over the study period, the number of patients increased by 14%, with gender structure gradually changing and the ratio of men decreasing from 44.3% to 39.9%. Two-thirds of the patients received drug therapy for the primary disease. Total outpatient costs ranged from 407.6 million rubles in 2020 to 615.3 million rubles in 2022. CM share of drug therapy averaged 98% of the total cost. Over 2020–2022, the highest patient coverage, number of packages, and cost level was attributed to dabrafenib+trametinib and vemurafenib+cobimetinib combinations. They accounted for an average of 85% of all patients and almost 99% of all costs. Over the 3-year period, there was a twofold cost increase for dabrafenib and trametinib, with a comparable twofold cost decrease for vemurafenib and cobimetinib.

CONCLUSIONS. Pharmacotherapy structure, dynamics, and cost has been evaluated in CM patients of Moscow region over 2020–2022. The obtained data can be used to optimise pharmacotherapy of CM patients at the regional level by widely introducing both clinical and pharmacoeconomic evaluation principles of treatment approaches.

1. Zhukovets A. Modern principles and prospects of skin melanoma treatment. Oncological Journal. 2015;9(4):69–76 (In Russ.). EDN: WAHZGT

2. Kharkevich GYu, Utyashev IA, Orlova KV, Demidov LV. Drug therapy for metastatic skin melanoma: What has been done and what should be done. Effective Pharmacotherapy. 2020;16(18):6–19 (In Russ.). EDN: FVLNAD

3. Sharov SV, Leonov MG. Prospects for melanoma of the skin drug treatment. Effective Pharmacotherapy. 2018;(25):50–3 (In Russ.). EDN: XZDGSL

4. Arance A, de la Cruz-Merino L, Petrella TM, et al. Phase II LEAP-004 study of lenvatinib plus pembrolizumab for melanoma with confirmed progression on a programmed cell death protein-1 or programmed death ligand 1 inhibitor given as monotherapy or in combination. J Clin Oncol. 2023;41(1):75–85. https://doi.org/10.1200/JCO.22.00221

5. Lyrarakis G, Liontos M, Anastasopoulou A, et al. Immunotherapy after progression to double immunotherapy: Pembrolizumab and lenvatinib versus conventional chemotherapy for patients with metastatic melanoma after failure of PD-1/CTLA-4 inhibition. Front Oncol. 2024;14:1420879. https://doi.org/10.3389/fonc.2024.1420879

6. Rousset P, Nardin C, Maubec E, et al. Real-world outcomes of combined lenvatinib and anti-PD-1 in advanced melanoma: The Lenvamel study, a multicenter retrospective study of the French Group of Skin Cancers (Groupe de Cancérologie Cutanée). Oncologist. 2024;29(10):e1364–e1372. https://doi.org/10.1093/oncolo/oyae145

7. Ferrucci PF, Di Giacomo AM, Del Vecchio M, et al. KEYNOTE–022 part 3: a randomized, double-blind, phase 2 study of pembrolizumab, dabrafenib, and trametinib in BRAF-mutant melanoma. J Immunother Cancer. 2020;8(2):e001806. https://doi.org/10.1136/jitc-2020-001806

8. Borobova EA, Zheravin AA. Immunotherapy for melanoma. Siberian Journal of Oncology. 2017;16(4):65–75 (In Russ.). https://doi.org/10.21294/1814-4861-2017-16-4-65-75

9. Fizazi K, Maillard A, Penel N, et al. LBA15_PR — A phase III trial of empiric chemotherapy with cisplatin and gemcitabine or systemic treatment tailored by molecular gene expression analysis in patients with carcinomas of an unknown primary (CUP) site (GEFCAPI 04). Ann Oncol. 2019;30(5S):v851. https://doi.org/10.1093/annonc/mdz394

10. Poliakova КI, Holownia-Voloskova ME, Byakhov MYu, et al. Comparative analysis of cost of drug therapy of the most high-cost oncological diseases in Moscow. Malignant Tumours. 2018;8(2):12–20 (In Russ.). https://doi.org/10.18027/2224-5057-2018-8-2-12-20

11. Krysanova V, Poliakova K, Ermolaeva T, et al. Health and economic burden in direct costs of melanoma in Moscow for 2016–2017. Eur J Clin Pharmacol. 2019;75(S1):19–20. https://doi.org/10.1007/s00228-019-02685-2

12. Kokushkin KA, Zhuravleva MV, Byakhov MYu, et al. Review of pharmacoeconomic studies of melanoma treatment for the period 2018–2023. South Russian Journal of Therapeutic Practice. 2023;4(3):36–44 (In Russ.). https://doi.org/10.21886/2712-8156-2023-4-3-36-44

13. Kokushkin KA, Krysanova VS, Makarova EV, et al. Analysis of drug therapy for patients with metastatic melanoma of the skin using the example of the Moscow region. Good Clinical Practice. 2025;(3):4–16 (In Russ.). https://doi.org/10.37489/2588-0519-2025-3-4-16

14. Sokolova OV, Morzhukhina EV, Shakh-Paronyants YuS, Alekseyeva KS. Analysis of treatment of malignant skin melanoma at the regional. Modern Organization of Drug Supply. 2021;8(1):84–8 (In Russ.). EDN: EXQQMJ

15. Petrukhina IK, Ryazanova TK, Gladunova EP, et al. Sales of antitumor drugs in the retail segment of the Russian pharmaceutical market. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(4):619–29 (In Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.212