Issue № 1 | 2019 (35)
Introduction. In 2018 the Federal Order of 03.08.2018 No. 299-FO was adopted, whereby the provision of drugs for the treatment of systemic juvenile idiopathic arthritis (sJA) was delegated to the federal level.
Aim. In accordance with the requirements for the development of formularies of medicines, approved by Decree of the Government of the Russian Federation No. 871, the budget impact analysis of inclusion in the expensive drugs list of canakinumab for the treatment of sJA was conducted.
Material and methods. The drug costs were calculated based on the manufacture`s maximum selling price inclusive of all taxes and additional charges according to the legislation of the Russian Federation. Characteristics and the size of the target population of patients diagnosed with sJA were determined based on the data from different sources – clinical trials, registries, standards, of medical care, experts` judgment. The time horizon of the analysis is 1 year and 3 years. The sensitivity analysis was performed to test how results affected by changes in key assumptions such as drug price and size of the target population.
Results. The budget impact analysis revealed that provision for the target population of canakinumab for the treatment of sJA does not require a significant increase in the programme budgeting of costly diseases. The insignificant increase is required for the programme budgeting equal to the amount of 1,588 billion per year, which is 4% less than the 2018 budget.
Conclusions. Assurance of centralized purchasing of canakinumab from federal budget resources is in harmony with the financing capacity of costly diseases programme, extended from 2019, to cover canakinumab reimbursement for patients with sJA.
systemic onset juvenile arthritis (sJA), canakinumab, costly diseases programme, budget impact analysis.
Derkach E.V. Budget Impact Analysis of Inclusion in the Expensive Drugs List of Canakinumab for Treatment of Systemic Onset Juvenile Arthritis. Medical Technologies. Assessment and Choice. 2019; 1(35): 66–73.