Cost-Effectiveness of Sofosbuvir-Based Triple Therapy for... : Hepatology (original) (raw)

VIRAL HEPATITIS

Cost-Effectiveness of Sofosbuvir-Based Triple Therapy for Untreated Patients With Genotype 1 Chronic Hepatitis C

Petta, Salvatore1; Cabibbo, Giuseppe1; Enea, Marco2; Macaluso, Fabio Salvatore1; Plaia, Antonella2; Bruno, Raffaele3; Gasbarrini, Antonio4; Craxì, Antonio1; Cammà, Calogero1 WEF Study Group

1 Sezione di Gastroenterologia, Di.Bi.M.I.S., University of Palermo, Palermo, Italy

2 Dipartimento di Scienze Economiche, Aziendali e Statistiche (SEAS), University of Palermo, Palermo, Italy

3 Division of Infectious and Tropical Diseases, Foundation IRCCS San Matteo Hospital, University of Pavia, Pavia, Italy

4 Università Cattolica del Sacro Cuore, Facoltà di Medicina e Chirurgia, Gastroenterologia Rome, Rome, Italy

Received 9 August 2013; accepted 4 December 2013.

Address reprint requests to: Prof. Calogero Cammà, Sezione di Gastroenterologia, University of Palermo, Piazza delle Cliniche, 2, 90127 Palermo, Italy. E-mail:[email protected]; fax +39 091 655 2156.

Potential conflict of interest: Calogero Cammà, Raffaele Bruno, Antonio Gasbarrini and Antonio Craxì have received consulting fees from Gilead, Janssen, Roche and MSD. Dr. Bruno also received grants from Gilead, Janssen, MSD, and Roche, and consults for and received grants from AbbVie and Boehringer Ingelheim.

The study was funded by 3P Solution. The funding agency was not involved in the study design or its execution, data management or analysis, article preparation or review, or the decision to submit the article for publication.

Abstract

We assessed the cost-effectiveness of sofosbuvir (SOF)-based triple therapy (TT) compared with boceprevir (BOC)- and telaprevir (TVR)-based TT in untreated genotype 1 (G1) chronic hepatitis C (CHC) patients discriminated according to IL28B genotype, severity of liver fibrosis, and G1 subtype. The available published literature provided the data source. The target population was made up of untreated Caucasian patients, aged 50 years, with G1CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs (in euros at 2013 value), life-years gained (LYG), quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Cost of SOF was assumed to be €3,500 per week, i.e., the price generating a willingness-to-pay threshold of €25,000 per LYG compared with TVR in the entire population of untreated G1 patients. The robustness of the results was evaluated by one-way deterministic and multivariate probabilistic sensitivity analyses. SOF was cost-effective compared with BOC in all strategies with the exception of cirrhosis and IL28B CC patients. In comparison with TVR-based strategies, SOF was cost-effective in IL28B CT/TT (ICER per LYG €22,229) and G1a (€19,359) patients, not cost-effective in IL28B CC (€45,330), fibrosis F0-F3 (€26,444), and in cirrhosis (€34,906) patients, and dominated in G1b patients. The models were sensitive to SOF prices and to likelihood of sustained virological response.

Conclusion:

In untreated G1 CHC patients, SOF-based TT may be a cost-effective alternative to first-generation protease inhibitors depending on pricing. The cost-effectiveness of SOF improved in IL28B CT/TT and G1a patients. SOF was dominated by TVR in G1b patients even if, in clinical practice, this issue could be counterbalanced by the good tolerability profile of SOF and by the shorter treatment duration. (Hepatology 2014;59:1692–1705)