Cost-effectiveness of sofosbuvir-based treatments for chronic hepatitis C in the US

Abstract

BackgroundThe standard care of treatment of interferon plus ribavirin (plus protease inhibitor for genotype 1) are effective in 50 % to 70 % of patients with CHC. Several new treatments including Harvoni, Olysio + Sovaldi, Viekira Pak, Sofosbuvir-based regimens characterized with potent inhibitors have been approved by the Food and Drug Administration (FDA) providing more options for CHC patients. Trials have shown that the new treatments increased the rate to 80 % to 95 %, though with a substantial increase in cost. In particular, current market pricing of a 12-week course of sofosbuvir is approximately US$84,000. We determine the cost-effectiveness of new treatments in comparison with the standard care of treatments.MethodsA Markov simulation model of CHC disease progression is used to evaluate the cost-effectiveness of different treatment strategies based on genotype. The model calculates the expected lifetime medical costs and quality adjusted life years (QALYs) of hypothetical cohorts of identical patients receiving certain treatments. For genotype 1, we compare: (1) peginterferon + ribavirin + telaprevir for 12 weeks, followed by 12 or 24 weeks treatment of peginterferon + ribavirin dependent on HCV RNA level at week 12; (2) Harvoni treatment, 12 weeks; (3) Olysio + Sovaldi, 12 weeks for patients without cirrhosis, 24 weeks for patients with cirrhosis; (4) Viekira Pak + ribavirin, 12 weeks for patients without cirrhosis, 24 weeks for patients with cirrhosis; (5) sofosbuvir + peginterferon + ribavirin, 12 weeks for patients with or without cirrhosis. For genotypes 2 and 3, treatment strategies include: (1) peginterferon + ribavirin, 24 weeks for treatment-naïve patients; (2) sofosbuvir + ribavirin, 12 weeks for patients with genotype 2, 24 weeks for genotype 3; (3) peginterferon + ribavirin as initial treatment, 24 weeks for patients with genotype 2/3, follow-up treatment with sofosbuvir + ribavirin for 12/16 weeks are performed on non-responders and relapsers.ResultsViekira Pak is cost-effective for genotype 1 patients without cirrhosis, whereas Harvoni is cost-effective for genotype 1 patients with cirrhosis. Sofosbuvir-based treatments for genotype 1 in general are not cost-effective due to its substantial high costs. Two-phase treatments with 12-week and 16-week follow-ups are cost-effective for genotype 3 patients and for genotype 2 patients with cirrhosis. The results were shown to be robust over a broad range of parameter values through sensitivity analysis.ConclusionsFor genotype 1, sofosbuvir-based treatments are not cost-effective compared to Viekira Pak and Harvoni, although a 30 % reduction in sofosbuvir price would change this result. Sofosbuvir + ribavirin are cost-effective as second-phase treatments following peginterferon + ribavirin initial treatment for genotypes 2 and 3. However, there is limited data on sofosbuvir-involved treatment, and the results obtained in this study must be interpreted within the model assumptions.

Drug therapies for chronic hepatitis C infection: a cost-effectiveness analysis

“…[40][41][42][43] Most studies concluded that it is costeffective to treat genotype 1 with interferon-free direct-acting antiviral agents compared with pegylated interferon-ribavirin-based direct-acting antiviral agents. More recently, additional studies have reported incremental cost-effectiveness for other genotypes.…”

Health Economic Evaluations of Sofosbuvir for Treatment of Chronic Hepatitis C: a Systematic Review

“…1. Fourteen studies were then included in the review, all of them published in English [16][17][18][19][20][21][22][23][24][25][26][27][28][29].…”

“…In the 14 studies, which were published between 2013 and 2015, health economic evaluations for seven different countries were conducted: France [21], Germany [19], Italy [17,25], Spain [28], Switzerland [26], the UK [18] and the USA [16, 20, 22-24, 27, 29]. In all studies, the cost-effectiveness of sofosbuvir-based treatment was assessed from the perspective of the respective payer, though Zhang et al [29] did not state the perspective of their analysis. In four studies, the authors stated that a societal perspective was applied [20,21,23,24]; none of them, however, considered costs other than direct medical costs.…”

“…Referring to the study results, almost all evaluations (except for those by Hagan et al [20] and Leleu et al [21]) determined ICERs/ICURs separately per genotype. In several studies, additional separate analyses were performed for treatment history (n = 7) [16-18, 22, 26-28], cirrhosis status (n = 6) [16,17,22,25,27,29] and interferon eligibility (n = 3) [17,18,26].…”

“…For example, the annual costs of care for CHC without cirrhosis assigned for the USA varied between US$184 [20] and US$4872 [27]. Likewise, the costs associated with hepatocellular carcinoma varied between US$25,863 [29] and US$86,116 [27]. A comparison of the assigned costs in the studies performed from the perspective of the USA is available in Table 2.…”