Legal, organizational and financial mechanisms for providing medicines not included in the list of vital and essential drugs in the State guaranteed free medical care program for citizens (using anticancer drug therapy as an example)

Objective. To identify current organizational and financial mechanisms for providing anticancer medicines not included in the list of vital and essential drugs in the state guaranteed free medical care program for citizens. Material and methods. The first stage examined regulatory documents establishing prescription of drugs outside the list of vital and essential drugs at the federal level. In the second stage, analysis of territorial state guarantee programs (2026) determined organizational and financial mechanisms for providing anticancer drugs not included in the list of vital and essential drugs. Results. Federal regulations stipulate that drugs not included in the list of vital and essential drugs may be prescribed free of charge only by medical commission with mandatory completion of a protocol including a justification related to vital necessity or individual intolerance. Federal regulations do not limit funding for drugs not included in the list of vital and essential drugs. However, methodological recommendations for payment methods from compulsory health insurance (CHI) funds impose tariff restrictions for anticancer drugs (regardless of anticancer drug cost payment is possible at the lowest CHI tariffs). Analysis of territorial state-funded programs identified three organizational and financial mechanisms currently implemented in constituent entities of the Russian Federation for providing anticancer drugs (including high-cost, targeted drugs) not included in the list of vital and essential drugs: 1) expanding the range of regional benefit lists for outpatient treatment based on prescriptions and financed by regional budget; 2) programs (procedures) for additional drug provision for patients in day and 24-hour hospital settings using subsidies from regional budget; 3) allocating a subgroup of diagnosis-related groups for infusion targeted drugs to provide patients in day hospital settings using interbudgetary transfer funds allocated from budget of constituent entity of the Russian Federation for financial support of territorial compulsory medical insurance program with establishment of additional coverage for insured events covered by basic compulsory medical insurance program. Conclusion. The growing number of expensive, highly effective, and, in some cases, uncontested innovative targeted anticancer drugs registered in the Russian Federation in recent years, but not included in the list of vital and essential drugs for various reasons, coupled with high prevalence of malignant neoplasms, necessitates additional organizational and financial mechanisms in constituent entities of the Russian Federation to provide patients with malignant neoplasms with drugs beyond the list of vital and essential drugs.