Issue № 32 | 2018 (2)
Introduction. Atrial fibrillation (AF) significantly increases the risk of stroke and thromboembolic complications in patients. Traditionally, warfarin has been used to prevent stroke and thromboembolic complications in AF, but the so-called novel oral anticoagulants (NOAC) are more effective, and significantly reduce the risk of large bleeding requiring hospital treatment. Presently the three NOACs are included into the Vital and Essential Drug List (VEDL) – apixaban, dabigatran and rivaroxaban, but only the last two drugs have been included into the program of Essential Medicines Provision (EMP) for outpatient treatment.
Objective of the study: cost-effectiveness analysis of apixaban used for the prevention of stroke and systemic thromboembolism in AF and budget impact analysis of its inclusion into the EMP program.
Methods. Based on published results of indirect comparison we developed a model for calculating the direct medical costs including the cost of NOACs and major bleedings treatment. The study was performed from the health care system perspective. The cost of the drugs was determined on the basis of registered maximum sales prices, taking into account the weighted RF average wholesale markup and VAT. The costs of treating major bleeding were calculated on the basis of financial norms approved by the Program of State Guarantees of Free Medical Care (SGPFMC) for 2017. The number of the target population was modeled on the basis of public procurement data for 2013-2017. The modeling horizon was 3 years. A budget impact analysis and cost minimization analysis were performed. Sensitivity analysis was made.
Results. The average cost of 1 year of NOAC therapy with a full dose of apixaban is 29,843.58 rubles, which is 36.5% lower than dabigatran (46,979.44 rubles) and 30.1% lower than rivaroxaban (42,678.88 rubles). In case of using reduced doses, the cost of apixaban will be 29,909.58 rubles, which is also significantly lower than the cost of dabigatran and rivaroxaban – by 38.0% and 29.3%, respectively. Inclusion of apixaban into the EMP Program will reduce the additional costs of the State Guarantees Program from 54.4% to 20.6% (33.8%), while the total annual direct costs will decrease from 2 201.9 million rubles up to 1719.0 million rubles (by 21.9%). The results of the sensitivity analysis showed the stability of simulation results to the variabilities of the input parameters of the model.
Conclusion. Apixaban’s efficacy is similar to the drugs already included into EMP Program, but it has a lower risk of a major bleeding. Its inclusion into EMP will limit the costs’ growth due to the increase of number of patients with AF who receive NOACs for the prevention of strokes and systemic thromboembolism, or reduce costs within a stable population size.
atrial fibrillation, prevention of thromboembolic complications, apixaban, dabigatran etexilate, rivaroxaban, pharmacoeconomic study.
Derkach E. V., Boyarskaya Т. V. Pharmacoeconomic Study of the Eliquis (Apixaban) Use within the Program of Essential Medicines Provision in the Russian Federation. Medical Technologies. Assessment and Choice. 2018; 2(32): 94–102.