Orphan drugs for the pathogenetic treatment of rаre diseases in the drug registry

Abstract

Introduction. Despite the high cost of life-threatening rаre diseases, not all expensive drugs for the pathogenetic treatment of orphan diseases are included in the list of vital and essential drugs. Aim. Analysis of drugs for pathogenetic treatment of diseases included in the orphan drugs lists, in order to determine the specific names not included in the list of vital and essential drugs (VET List) for medical use in 2019. Materials and methods. From the standards of medical care for rare diseases included in the Decree of the Government of the Russian Federation of April 26, 2012 № 403 and the order of the government of the Russian Federation of December 10, 2018 № 2738-p allocated 62 international non-patented names of drugs. The data obtained from the relevant INN in the State register of drugs of the Russian Ministry of health of was analyzed. Results. 90 % of the drugs are reference, 34 % interchangeable, 81 % of the considered included in the VET List for 2019. The remaining 19 % is not necessary and therefore does not have a registered selling price. Summary. Analysis of orphan drug lists revealed the absence of some of the expensive drugs in the VET List, which makes it impossible to control the maximum selling prices of the manufacturer by the government.

Keywords

• орфанные препараты
• редкие заболевания
• перечень жизненно необходимых и важнейших лекарственных препаратов