Objective. To conduct a pharmacoepidemiological and pharmacoeconomic analysis of specialized inpatient medical care provided to patients with metastatic melanoma (MM) in the Moscow Region during 2020–2022.
Materials and methods. A retrospective pharmacoepidemiological analysis of specialized inpatient medical care provided to patients with MM in Moscow Region during 2020–2022 was performed, followed by a cost analysis. The study analyzed the total number of patients receiving various drug therapy regimens with their main clinical characteristics (gender, age, diagnosis code), the total number of hospitalizations considering their structure (inpatient/day hospital), the average number of hospitalizations per patient, and the average length of hospital stay. The cost analysis examined both total costs and their structure across different drug regimens. The results were processed using Microsoft Excel 2019 and are presented as absolute values and percentages (%).
Results. This study examined 10,609 cases of specialized and primary specialized inpatient medical care provided to patients diagnosed with ICD-10 C43.0–43.9 in healthcare facilities of the Moscow Region from 2020 to 2022 (4,471 cases in 2020, 2,970 cases in 2021, and 3,168 cases in 2022). During the analysis period, the number of patients with MM receiving inpatient treatment decreased by 29 %, whereas the average number of hospitalizations per patient was 6.2 in 2020, 5.2 in 2021, and 6.3 in 2022. The hospitalization structure showed a trend toward decreasing the proportion of care provided in the 24-hour inpatient setting. The total costs of specialized medical care for patients with MM ranged from 1.8 billion rubles (2020) to 1.1 billion rubles (2022). In 2020, the three most demanded regimens by number of patients and hospitalizations were nivolumab, pembrolizumab, and dabrafenib + trametinib combination. This pattern persisted until 2021. In 2022, a shift in MM pharmacotherapy priorities was observed — alongside nivolumab and pembrolizumab regimens, prolgolimab became one of the most demanded treatments. These regimens were administered to more than 80 % of patients with MM at each time interval. Cost analysis revealed that in 2020, the same regimens that led in patient numbers also accounted for more than 95 % of total costs. In 2021 and 2022, the costliest regimens were those using nivolumab, pembrolizumab, and the combination of ipilimumab and nivolumab, accounting for more than 90 % of the costs. Drug therapy using pembrolizumab and nivolumab became the absolute leader both in patient numbers and costs throughout the entire analysis period, with nivolumab showing a gradual decrease in both patient numbers (1.7-fold) and cost levels (3.2-fold), while pembrolizumab showed the opposite trend —growth (1.5-fold and 1.9-fold, respectively).
Conclusions. The results of this analysis can contribute to further improvement of the regional medical care system for patients with MM, thereby enhancing the quality and accessibility of modern and highly effective pharmacotherapy approaches.

Objective. To conduct a pharmacoepidemiologic and pharmacoeconomic analysis of government procurement of drugs for the treatment of metastatic melanoma (MM) in Moscow region during 2020–2022, assessing the compliance of real clinical practice with current recommendations and identifying opportunities to optimize drug provision for patients.

Materials and methods. A retrospective pharmacoepidemiologic analysis of data on government procurement of key drugs used in the treatment of metastatic MM for the period 2020–2022 in Moscow region was performed, followed by a cost analysis. The analysis included 17 INNs: vemurafenib, vinblastine, dabrafenib, dacarbazine, imatinib, interferon alfa-2b, ipilimumab, carboplatin, cobimetinib, lomustine, nivolumab, paclitaxel, pembrolizumab, prolgolimab, temozolomide, trametinib, and cisplatin. The number of customers, trade names, dosage forms and packaging, number of packages purchased, cost per package, and total costs were analyzed. The average cost per 1 mg of active substance was separately evaluated over time. The results were processed using MS Excel 2019 and presented as absolute values and percentages.

Results. Data from the procurement information system (https://zakupki.gov.ru) for 2020–2022 were analyzed, covering 1,831 government procurements of 17 INNs used for MM treatment in Moscow region healthcare facilities (622 in 2020, 686 in 2021, 523 in 2022). Total expenditure for the 17 INNs amounted to 4.8 billion rubles for the entire 2020–2022 period (1.3 billion in 2020, 1.8 billion in 2021, 1.7 billion rubles in 2022), with an increase in expenditure of more than 30 %. The cost structure was dominated by 3 INNs throughout the analyzed period — dabrafenib, nivolumab, and pembrolizumab, accounting for an average of 76.5 % of all expenses. During 2020–2022, pembrolizumab was the absolute leader (accounting for 39.2 % of purchases in 2020, 33.3 % in 2021, and 35.2 % in 2022), with cost growth of 1.2 times. Regarding the average cost per 1 mg of active substance, the most expensive MM treatments were: ipilimumab, trametinib, pembrolizumab, prolgolimab, and nivolumab. Over the 3-year period, among these INNs, only ipilimumab showed an increase in the average cost per 1 mg (+18.6 %), while prolgolimab showed a significant decrease (–17.2 %). When comparing different healthcare settings, there is a clear trend toward decreasing numbers of patients receiving oral targeted therapies in inpatient settings, while in outpatient settings the number of patients significantly increases, especially evident for the combination of dabrafenib and trametinib.

Conclusions. Our study is the first example of a comprehensive pharmacoepidemiologic and pharmacoeconomic analysis covering various aspects of drug provision for patients with metastatic MM — government procurement, provision within preferential drug supply programs, and specialized medical care in hospital settings. The research results create an information base for making clinically and economically sound healthcare decisions, which can be used in developing regional oncology service programs, planning drug procurement, and improving the drug supply system for patients with metastatic MM.