Estimating the cost‐effectiveness of daclatasvir plus asunaprevir in difficult to treat Japanese patients chronically infected with hepatitis C genotype 1b

McEwan, Phil; Ward, Thomas; Webster, S.; Yuan, Yong; Kalsekar, Anupama; Kamae, Isao; Kobayashi, Masahiro; Tang, Ann; Kumada, Hiromitsu

doi:10.1111/hepr.12570

Cited by 23 publications

(20 citation statements)

References 28 publications

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“…Although DCV/ASV dual therapy has not been approved to treat HCV infection everywhere in the world, and ledipasvir/sofosbuvir is the first-line therapy, DCV/ASV dual therapy has clinical importance in Asian countries such as Japan, China, Korea, and Taiwan. In Japan, DCV/ASV dual therapy is expected to be cost-saving for patients with HCV genotype 1b who have failed prior therapy or are IFN-ineligible/intolerant [31]. In addition, DCV/ASV dual therapy for chronic hemodialysis patients with HCV infection is highly effective and well tolerated, even for elderly patients and patients with liver cirrhosis or the resistance-associated variant NS5A-Y93H at baseline [32].…”

Section: Discussionmentioning

confidence: 99%

Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy

et al. 2017

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The aim of this study was to determine the efficacy of two hepatitis C virus (HCV) real-time PCR assays, the COBAS AmpliPrep/COBAS TaqMan HCV test (CAP/CTM) and the Abbott RealTime HCV test (ART), for predicting the clinical outcomes of patients infected with HCV who received telaprevir (TVR)-based triple therapy or daclatasvir/asunaprevir (DCV/ASV) dual therapy. The rapid virological response rates in patients receiving TVR-based triple therapy were 92% (23/25) and 40% (10/25) for CAP/CTM and ART, respectively. The false omission rate (FOR) of ART was 93.3% (14/15), indicating that CAP/CTM could accurately predict clinical outcome in the early phase. In an independent examination of 20 patients receiving TVR-based triple therapy who developed viral breakthrough or relapse, the times to HCV disappearance by ART were longer than by CAP/CTM, whereas the times to HCV reappearance were similar. In an independent experiment of WHO standard HCV RNA serially diluted in serum containing TVR, the analytical sensitivities of CAP/CTM and ART were similar. However, cell cultures transfected with HCV and grown in medium containing TVR demonstrated that ART detected HCV RNA for a longer time than CAP/CTM. Similar results were found for 42 patients receiving DCV/ASV dual therapy. The FOR of ART was 73.3% (11/15) at week 8 after initiation of therapy, indicating that ART at week 8 could not accurately predict the clinical outcome. In conclusion, although CAP/CTM and ART detected HCV RNA with comparable analytical sensitivity, CAP/CTM might be preferable for predicting the clinical outcomes of patients receiving protease inhibitor-based therapy.

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Section: Discussionmentioning

confidence: 99%

Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy

et al. 2017

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“…Medical costs were estimated according to McEwan et al 12) Model and Parameters The simulation in this study used a Markov model. The model and parameters were based on the model described by McEwan et al, 12,13) "modeling the natural history and cost-effectiveness of hepatitis" (MONARCH), defined as the standard method in the review of HCV costeffectiveness studies (published in the period of 2000-2011). 14) In addition, Kamae et al 9) suggested several points to consider when using the MONARCH model in Japanese patients.…”

Section: )mentioning

confidence: 99%

“…SVR comp-LC (first year only) 122873 McEwan et al 13) 0.960 Ishida et al 20) CH monitoring 119576 McEwan et al 13) 0.920 Ishida et al 20) CH care 97610 McEwan et al 13) comp-LC monitoring 171090…”

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confidence: 99%

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Cost-Outcome Description of PEG-IFN-α2b+RBV for Hepatitis C: Results Based on the Interferon Database

Akutagawa

Kawasaki

et al. 2017

Biological & Pharmaceutical Bulletin

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Economic evaluation of drugs is used in decision-making on medical care and public policy. Recently, real-world data (RWD) have been used in the analysis. In this study, we discuss the risk and benefits of using RWD for economic evaluation. We conducted a cost-outcome description with RWD from a nationwide registry providing information on hepatitis treatment in Japan and estimated the utility of the analysis. We evaluated the cost-outcome description of peginterferon plus ribavirin (PEG-IFN-α2b RBV) treatment in hepatitis C virus (HCV)-infected patients. Simulations were based on a Markov model. The cohorts were set using data from the registry and we assumed a societal perspective for the calculation of costs. The dose and drug cost were chosen based on the Japanese Guidelines for the Management of Hepatitis C Virus Infection or package inserts. Model details and parameters were as described in previous studies. The simulations were performed for a period of 10 years with no discount rate. We estimated 2.5 million JPY per Quality Adjusted Life Year (QALY) in 48-week PEG-IFN-α2b RBV treatment for a period of 10 years. The results of this study are in agreement with previous HCV treatment economic evaluation studies in Japan. We analyzed the statistics of the HCV-infected patients at each disease stage using the data in our registry and calculated the costs. The results of this study more closely reflect a real-world clinical situation compared to the widely used randomized clinical trial method, which estimates clinical trial results and scenarios.

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“…There have been numerous cost‐effectiveness analyses suggesting that the use of DAAs is cost‐effective in treating CHC patients in western countries . However, only limited Asian reports are available . Moreover, owing to the high drug costs of DAAs and the lower affordability of people from less developed countries, whether one should use DAAs directly in naïve patients or only for retreatment remains unclear.…”

Section: Introductionmentioning

confidence: 99%

Cost‐effectiveness of the highly effective direct‐acting antivirals in the treatment of chronic hepatitis C in Hong Kong

Lo¹,

Chan

Wong

et al. 2017

J of Gastro and Hepatol

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Estimating the cost‐effectiveness of daclatasvir plus asunaprevir in difficult to treat Japanese patients chronically infected with hepatitis C genotype 1b

Cited by 23 publications

References 28 publications

Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy

Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy

Cost-Outcome Description of PEG-IFN-α2b+RBV for Hepatitis C: Results Based on the Interferon Database

Cost‐effectiveness of the highly effective direct‐acting antivirals in the treatment of chronic hepatitis C in Hong Kong

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