Abstract

Objective. Cost-effectiveness analysis (CEA) of elbasvir in combination with grazoprevir (EBR/GZR) for the treatment of patients with chronic hepatitis C (CHC), infected with genotype 1 subtype b, who previously did not receive antiviral therapy (AVT), without cirrhosis or with compensated cirrhosis, from a Russian healthcare system perspective. Methods. In a model, developed in MS Office (Microsoft Excel® package), the differences in direct medical costs were determined (using cost minimization analysis) by comparing EBR/GZR and 3D (the combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir), which have comparable effectiveness in patients with chronic hepatitis C (genotype 1b). Besides, changes in costs for the treatment of patients with CHC (genotype 1b), if EBR/GZR are reimbursed, are analysed under the State-guaranteed benefit package (SGBP) for free medical care for the citizens of the Russian Federation (budget impact analysis). Frequencies of long-term consequences of CHC (number of cases of decompensated cirrhosis and hepatocellular carcinoma) were projected in the long run depending on whether AVT is administered or not, for 20 years or lifetime time horizon. For calculations, data from literature and standard financial expenditures in Russian healthcare system in 2018 were used. Univariate (one-way) sensitivity analysis was conducted to assess the impact in the price change of EBR/GZR package on the results of the analysis. Results. Average cost per patient for therapy with EBR/GZR was 510 142 rubles, or 21% less than for therapy with 3D that was 645 614 rubles. If EBR/GZR are included in Vital and Essential Drugs List (VED), expenditures under SGBP for treatment of CHC (genotype 1b) are expected to decrease by 16,1% in three years: by 9,4% in the first year, 15,7% in the second year and by 21% in the third year. Conclusions: Using EBR/GZR in clinical practice is efficient and leads to an improvement in the competitiveness in the field. It also allows reducing the additional healthcare system expenditures on direct-acting antiviral agents (DAAA) in AVT of CHC, and provides highly-effective therapeutic regimes under SGBP for patients without increasing the budget. Greater accessibility of DAAA (EBR/GZR and 3D) within the Russian healthcare system and increased availability of these drugs for the patients will lead to a significant decrease in incidence of such severe and costly consequences of hepatitis as decompensated cirrhosis and hepatocellular carcinoma in comparison with no treatment in the long run.

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