The use of sonidegib in the treatment of patients with locally advanced basal cell carcinoma of the skin: an analysis of the impact on the Russian healthcare budget
https://doi.org/10.19163/2307-9266-2025-13-4-285-296
Abstract
Budget Impact Analysis (BIA) is a key step in justifying the inclusion of new medicines in the list of vital and essential medicines (VED). It allows you to predict the financial consequences of the introduction of therapy and evaluate the effectiveness of resource allocation, which is of particular importance when using innovative antitumor drugs.
The aim. Implementation of the BIA of Healthcare of the Russian Federation of the use of sonidegib to assess the feasibility of inclusion in the list of VEDs for the treatment of patients with locally advanced basal cell carcinoma (laBCCs).
Materials and methods. In the pharmacoeconomic model developed for use in the Russian Federation, the BIA was conducted for healthcare in the Russian Federation based on comparative modeling of two scenarios: basic (all patients receive vismodegib) and alternative (phased introduction of sonidegib with an increase in the share to 50% by the third year). The time horizon is 3 years. Direct medical costs, price data from VED registers, government procurement, regulatory allowances, demographic and epidemiological parameters are taken into account. Additionally, a one-way sensitivity analysis was performed in the range of ±10% of key variables
Results. An analysis of the impact on the healthcare budget of the Russian Federation showed that the inclusion of sonidegib in the list of VED will lead to a 3.15% reduction in budget costs for the treatment of patients with laBCCs (-37,270,334 rubles or -387,440.81 USD) within the modeled patient population. The presented BIA results remain stable with changes in the price of comparison drugs, the total population size and the distribution of patient flow over the years, with a deviation from the baseline value of ±10%.
Conclusion. Modeling shows that the inclusion of the drug sonidegib in the list of VED leads to a reduction in the costs of the healthcare system with a possible increase in the tolerability of therapy and an expansion of the therapeutic arsenal for the treatment of laBCCs, i.e. it is justified from the point of view of clinical and economic consequences. The results obtained confirm its pharmacoeconomic validity as an alternative to vismodegib in the treatment of laBCCs.
Keywords
About the Authors
M. Yu. FrolovRussian Federation
Candidate of Sciences (Medicine), Assistant Professor of the Department of Clinical Pharmacology and Intensive Care of the Volgograd State Medical University.
1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.
V. A. Rogov
Russian Federation
Candidate of Sciences (Pharmacy), Assistant Professor of the Department of Pharmaceutical Business Organization, Pharmaceutical Technology and Biotechnology of the Volgograd State Medical University.
1 Pavshikh Bortsov Sq., Volgograd, Russia, 400066.
O. I. Ivakhnenko
Russian Federation
Assistant of the Department of Regulatory Relations in the field of circulation of medicines and medical devices of the Sechenov First Moscow State Medical University (Sechenov University); Master of Law.
2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.
V. V. Ryazhenov
Russian Federation
Doctor of Sciences (Pharmacy), Head of the Department of Regulatory Relations in the Field of Circulation of Drug Products and Medical Devices of the Sechenov First Moscow State Medical University (Sechenov University).
2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.
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Review
For citations:
Frolov M.Yu., Rogov V.A., Ivakhnenko O.I., Ryazhenov V.V. The use of sonidegib in the treatment of patients with locally advanced basal cell carcinoma of the skin: an analysis of the impact on the Russian healthcare budget. Pharmacy & Pharmacology. 2025;13(4):285-296. (In Russ.) https://doi.org/10.19163/2307-9266-2025-13-4-285-296