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. 2013 Sep-Oct;16(6):973-86.
doi: 10.1016/j.jval.2013.07.006.

Cost-effectiveness of boceprevir in patients previously treated for chronic hepatitis C genotype 1 infection in the United States

Jagpreet Chhatwal  1 , Shannon A Ferrante, Cliff Brass, Antoine C El Khoury, Margaret Burroughs, Bruce Bacon, Rafael Esteban-Mur, Elamin H Elbasha
Affiliations

Cost-effectiveness of boceprevir in patients previously treated for chronic hepatitis C genotype 1 infection in the United States

Jagpreet Chhatwal et al. Value Health. 2013 Sep-Oct.

Abstract

Objectives: The phase 3 trial, Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol-2 (RESPOND-2), demonstrated that the addition of boceprevir (BOC) to peginterferon-ribavirin (PR) resulted in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection as compared with PR alone. We evaluated the cost-effectiveness of treatment with BOC in previously treated patients with chronic hepatitis C in the United States using treatment-related data from RESPOND-2 and PROVIDE studies.

Methods: We developed a Markov cohort model to project the burden of HCV disease, lifetime costs, and quality-adjusted life-years associated with PR and two BOC-based therapies-response-guided therapy (BOC/RGT) and fixed-duration therapy for 48 weeks (BOC/PR48). We estimated treatment-related inputs (efficacy, adverse events, and discontinuations) from clinical trials and obtained disease progression rates, costs, and quality-of-life data from published studies. We estimated the incremental cost-effectiveness ratio (ICER) for BOC-based regimens as studied in RESPOND-2, as well as by patient's prior response to treatment and the IL-28B genotype.

Results: BOC-based regimens were projected to reduce the lifetime incidence of liver-related complications by 43% to 53% in comparison with treatment with PR. The ICER of BOC/RGT in comparison with that of PR was $30,200, and the ICER of BOC/PR48 in comparison with that of BOC/RGT was $91,500. At a willingness-to-pay threshold of $50,000, the probabilities of BOC/RGT and BOC/PR48 being the preferred option were 0.74 and 0.25, respectively.

Conclusions: In patients previously treated for chronic HCV genotype-1 infection, BOC was projected to increase quality-adjusted life-years and reduce the lifetime incidence of liver complications. In addition, BOC-based therapies were projected to be cost-effective in comparison with PR alone at commonly used willingness-to-pay thresholds.

Keywords: Markov model; hepatitis C; protease inhibitor.

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Conflict of interest statement

All authors have completed the ICMJE Form for Disclosure of Potential Conflicts of Interest and report the following. Dr. Chhatwal is a former employee of Merck Sharp &Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ and has received consulting fees. Drs. Ferrante, El Khoury, Burroughs and Elbasha are current employees of Merck and hold stock and/or stock options. Dr. Brass is a former employee of Merck and holds stock and/or stock options. Dr. Bacon has received consultancy fees from Gilead, Three Rivers Pharmaceuticals, Valeant, Vertex, and Human Genome Sciences; has grants/grants pending from Roche, Gilead, Bristol Myers Squibb, Three Rivers Pharmaceuticals, Valeant, Vertex, Human Genome Sciences, Wyeth, and Romark Laboratories; payment for lectures including service on speakers bureaus for Three Rivers Pharmaceuticals, Gilead, and Merck; and served on Data and Safety Monitoring Boards for Novartis, ISIS, Vertex and Gilead. Dr Esteban is a member of the speaker’s bureau or is an advisor of Merck, Gilead, Novartis, Bristol-Myers Squibb and GlaxoSmithKline.

Figures

Figure 1
Figure 1
Strategies based on RESPOND-2 trial for treatment-experienced patients.
Figure 2
Figure 2
State-transition diagram for chronic hepatitis C and liver disease model. The model consists of two components: treatment and natural history. If patients discontinue treatment, or fail to achieve an end-of-treatment response (ETR) or a sustained virologic response (SVR), they enter the natural history component of the model, which consists of 14 health states. These include fibrosis states (F0–F4); decompensated cirrhosis (first year [DC1] and subsequent years [DC+]); hepatocellular carcinoma (HCC); liver transplant (first year [LT] and subsequent years [PLT]; liver-related death (Lv-Death); death from all other causes (not shown here); and SVR status states stratified by fibrosis stage (“SVR, F0–F3” and “SVR, F4”). Y= Yes; N=No. *For clarity, two decompensated states--DC1 and DC+ are shown as one state, i.e. DC.
Figure 3
Figure 3
Cumulative incidence of liver-related complications with PR48, BOC/RGT and BOC/PR48 treatment strategies; PR48= peginterferon-ribavirin regimen; BOC/RGT = Response Guided Therapy; BOC/PR48 peginterferon–ribavirin-boceprevir regimen; DC = decompensated cirrhosis; HCC = hepatocellular carcinoma; LT = liver-transplant Error bars were estimated using 10,000 Monte Carlo simulation runs.
Figure 4
Figure 4
Tornado diagram showing 25 most sensitive parameters in BOC/RGT p = transition probability, q: quality of life weight, c = cost
Figure 5
Figure 5
Tornado diagram showing 25 most sensitive parameters in BOC/PR48 p = transition probability, q: quality of life weight, c = cost
Figure 6
Figure 6
Cost-effectiveness acceptability curve. PR48= peginterferon-ribavirin regimen; BOC/RGT = Response Guided Therapy; BOC/PR48 peginterferon–ribavirin-boceprevir regimen.
See this image and copyright information in PMC

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