Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C

An analysis with real world outcomes from a multicentre cohort in Japan

Ataru Igarashi, Norihiro Furusyo, Eiichi Ogawa, Hideyuki Nomura, Kazufumi Dohmen, Nobuhiko Higashi, Kazuhiro Takahashi, Akira Kawano, Koichi Azuma, Takeaki Satoh, Makoto Nakamuta, Toshimasa Koyanagi, Masaki Kato, Shinji Shimoda, Eiji Kajiwara, Jun Hayashi

Research output: Contribution to journalArticle

Abstract

Objectives A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan. Method A Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: Treatment-naïve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2% was set for both cost and effectiveness. Results Incremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-Adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis. Conclusions The results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.

Original languageEnglish
Article numbere023405
JournalBMJ open
Volume9
Issue number6
DOIs
Publication statusPublished - Jun 1 2019

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Ribavirin
Chronic Hepatitis C
Cost-Benefit Analysis
Japan
Genotype
Fibrosis
Quality-Adjusted Life Years
Therapeutics
Liver Transplantation
Hepatocellular Carcinoma
Sofosbuvir
Pragmatic Clinical Trials
Drug Approval
Costs and Cost Analysis
Interferons
Multicenter Studies
Publications
Liver Diseases
Cohort Studies
Delivery of Health Care

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C : An analysis with real world outcomes from a multicentre cohort in Japan. / Igarashi, Ataru; Furusyo, Norihiro; Ogawa, Eiichi; Nomura, Hideyuki; Dohmen, Kazufumi; Higashi, Nobuhiko; Takahashi, Kazuhiro; Kawano, Akira; Azuma, Koichi; Satoh, Takeaki; Nakamuta, Makoto; Koyanagi, Toshimasa; Kato, Masaki; Shimoda, Shinji; Kajiwara, Eiji; Hayashi, Jun.

In: BMJ open, Vol. 9, No. 6, e023405, 01.06.2019.

Research output: Contribution to journalArticle

Igarashi, A, Furusyo, N, Ogawa, E, Nomura, H, Dohmen, K, Higashi, N, Takahashi, K, Kawano, A, Azuma, K, Satoh, T, Nakamuta, M, Koyanagi, T, Kato, M, Shimoda, S, Kajiwara, E & Hayashi, J 2019, 'Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C: An analysis with real world outcomes from a multicentre cohort in Japan', BMJ open, vol. 9, no. 6, e023405. https://doi.org/10.1136/bmjopen-2018-023405
Igarashi, Ataru ; Furusyo, Norihiro ; Ogawa, Eiichi ; Nomura, Hideyuki ; Dohmen, Kazufumi ; Higashi, Nobuhiko ; Takahashi, Kazuhiro ; Kawano, Akira ; Azuma, Koichi ; Satoh, Takeaki ; Nakamuta, Makoto ; Koyanagi, Toshimasa ; Kato, Masaki ; Shimoda, Shinji ; Kajiwara, Eiji ; Hayashi, Jun. / Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C : An analysis with real world outcomes from a multicentre cohort in Japan. In: BMJ open. 2019 ; Vol. 9, No. 6.
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abstract = "Objectives A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan. Method A Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: Treatment-na{\"i}ve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2{\%} was set for both cost and effectiveness. Results Incremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-Adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis. Conclusions The results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.",
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T1 - Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C

T2 - An analysis with real world outcomes from a multicentre cohort in Japan

AU - Igarashi, Ataru

AU - Furusyo, Norihiro

AU - Ogawa, Eiichi

AU - Nomura, Hideyuki

AU - Dohmen, Kazufumi

AU - Higashi, Nobuhiko

AU - Takahashi, Kazuhiro

AU - Kawano, Akira

AU - Azuma, Koichi

AU - Satoh, Takeaki

AU - Nakamuta, Makoto

AU - Koyanagi, Toshimasa

AU - Kato, Masaki

AU - Shimoda, Shinji

AU - Kajiwara, Eiji

AU - Hayashi, Jun

PY - 2019/6/1

Y1 - 2019/6/1

N2 - Objectives A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan. Method A Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: Treatment-naïve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2% was set for both cost and effectiveness. Results Incremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-Adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis. Conclusions The results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.

AB - Objectives A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval, this analysis is a cost-effectiveness analysis of SOF+RBV for genotype (GT) 2 non-cirrhosis (NC) and compensated cirrhosis (CC) patients using efficacy parameters obtained from a multicentre cohort study (Kyushu University Liver Disease Study; KULDS) in Kyushu area in Japan in order to reflect real-world clinical practice in Japan. Method A Markov model followed 10 000 patients (62 years old) over their lifetime. Four populations were followed: Treatment-naïve (TN)-NC, treatment-experienced (TE)-NC, TN-CC and TE-CC. Comparators were Peg-IFNα2b+RBV for TN-NC and CC patients and telaprevir (TVR)+Peg-IFNα2b+RBV for TE-NC patients. The sustained virological response (SVR) rates of SOF+RBV were taken from KULDS and those of comparators were obtained from systematic literature reviews. There were nine states (NC, CC, decompensated cirrhosis [DC], hepatocellular carcinoma [HCC], SVR [NC], SVR [CC], liver transplantation [LT], post-LT and death) in this model, and an increase in the progression rate to HCC due to ageing was also considered. The analysis was conducted from the perspective of a public healthcare payer, and a discount rate of 2% was set for both cost and effectiveness. Results Incremental cost-effectiveness ratios (ICERs) of SOF+RBV versus Peg-IFNα2b+RBV were ¥323 928 /quality-Adjusted life year (QALY) for TN-NC patients, ¥92 256/QALY for TN-CC patients and ¥1 519 202/QALY for TE-CC patients. The ICER of SOF+RBV versus TVR+Peg-IFNα2b+RBV was ¥849 138/QALY for TE-NC patients. The robustness of the results was determined by sensitivity analysis. Conclusions The results of this analysis strongly demonstrate the robustness of our previous findings that SOF+RBV regimens are cost-effective in the real world and clinical trial settings for Japanese GT2 NC and CC patients.

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