Inclusion of Ipragliflozin into the Vital and Essential Drugs List: Budget Impact Analysis

The sodium-glucose co-transporter type 2 inhibitors (SGLT2i) used in the treatment of type 2 diabetes mellitus (DM) do not only affect the blood glucose level, but also help to reduce body weight and blood pressure. Recently ipragliflozin, the new drug from the SGLT2i group has appeared on the Russian market. The aim of this study was to analyze the budget impact of including ipragliflozin into the vital and essential drugs (VED) list for treatment of type 2 DM in adults. Material and methods. Budget impact analysis was performed in a mathematical model. The modeling period was 5 years. The target population included adult patients with type 2 DM eligible for glucose-lowering therapy with SGLT2i. The number of patients during the modeling period was calculated based on the information about SGLT2i public procurement and the data from the Federal Register of DM (FRDM). The cost of ipragliflozin was calculated on the basis of the price planned for state registration if the drugis included into the VED list (2.118 rubles for 30 tablets, 50 mg each); costs of dapagliflozin and empagliflozin were equal to the registered maximum selling prices plus VAT and the weighted average maximum wholesale allowance in the Russian Federation. The sensitivity analysis was performed to the variability of prices and target population size. Results. The estimated number of patients treated with SGLT2i was 14.052 in the 1-st year and 47.392 in the 5-th year. The calculated difference in the cost of SGLT2i over 5 years between the current and the expected practice (if ipragliflozin is included into the VED list) was –3.02 million rubles (cost reduction by 0.06%). For the first year, costs decreased by 0.1 million rubles, or 0.02%. Conclusion. The inclusion of ipragliflozin into the VED list leads to a reduction in costs within the budget of the State guarantee program for free provision of medical care to citizens.