| Sumario: | Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX; Vosevi) is a single tablet that combines sofosbuvir with velpatasvir and voxilaprevir. It is recommended as a 12-week, single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection for patients without cirrhosis or with compensated cirrhosis. The manufacturer submitted a price of 714.29 dollar per tablet, or 60,000 dollar for a 12-week course. The manufacturer submitted a cost-utility analysis based on a Markov cohort model, where patients start in health states representing initial METAVIR scores (a scoring system used to assess the extent of inflammation and stage of fibrosis or scarring in patients with hepatitis C) with active chronic hepatitis C (CHC) infection, sustained virologic response (SVR) states, distal consequences of HCV infection, and death. The manufacturer presents results in the NS5A-naive and NS5A-experienced populations, each of which was stratified by cirrhosis status. The comparators considered were no treatment (both populations) and treatment with SOF/VEL (in NS5A-naive patients only). The SVR rates for SOF/VEL/VOX were based on the POLARIS trials, which established SVR rates of more than 96% in both NS5A-experienced (versus placebo, POLARIS-1) and NS5A-naive (versus SOF/VEL, POLARIS-4) patients. The manufacturer's results suggest that SOF/VEL/VOX is a cost-effective treatment option in patients with CHC with genotypes (GTs) 1 to 6 who are NS5A experienced as well as in GT1-4 patients who are NS5A naive, with SOF/VEL/VOX dominating SOF/VEL (i.e., offering higher quality-adjusted life-year (QALY) gains and lower overall costs) and associated with an incremental cost-utility ratio (ICUR) of 12,000 dollar per QALY compared with no treatment or SOF/VEL. Results were similar between the GT3 and non-GT3 populations for SOF/VEL/VOX compared with no treatment or SOF/VEL.
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