Possibility analysis of antiepileptic drugs import substitution in the Russian Federation

Abstract

Relevance. Epilepsy is a common chronic disease of the nervous system that can be treated rationally, ensuring the possibility of remission in most patients. The availability of antiepileptic drugs (AEDs) for patients with epilepsy is an important characteristic for achieving a long and quality life. Domestic AED production in the Russian Federation guarantees accessible medicinal assistance.Objective. Assessment of the AED import substitution level in the Russian Federation.Methods. The assessment is based on an analysis of the State Register of Medicines (SRM), the list of vital and essential drugs (VED) for 2023, and the clinical recommendations of the Ministry of Health of the Russian Federation “Epilepsy and status epilepticus in adults and children”.Results. Currently, the SRM registers 27 international non-proprietary names of AEDs, 101 trade names, mainly in the form of oral dosage forms, and 1,355 nomenclature items. All AEDs are prescription drugs. Generally, 70.6% of AED manufacturers are domestic. In 2020, the share of manufacturers from the Russian Federation increased by 20%. However, only 14.2% of the substances are directly produced in the Russian Federation. A high 100% level of import substitution is available only for firstgeneration antiepileptic drugs, and for third-generation drugs it remains at 43%. Import substitution of antiepileptic drug substances stays significantly low — 75% — 47.5% — 14% for antiepileptic drugs of I — II — III generations, respectively.Conclusion. The level of import substitution of modern AEDs for generations II–III should be increased to improve the efficiency and safety of epilepsy therapy.