Skip to main content
Top
Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Research article

Cost-effectiveness analysis of the introduction of S-1 therapy for first-line metastatic breast cancer treatment in Japan: results from the randomized phase III SELECT BC trial

Authors: Takeru Shiroiwa, Takashi Fukuda, Kojiro Shimozuma, Mitsuko Mouri, Yasuhiro Hagiwara, Takuya Kawahara, Shozo Ohsumi, Yasuo Hozumi, Yoshiaki Sagara, Yasuo Ohashi, Hirofumi Mukai

Published in: BMC Cancer | Issue 1/2017

Login to get access

Abstract

Background

This study evaluated the cost-effectiveness of replacing standard intravenous therapy (taxane) with oral S-1 therapy for first-line metastatic breast cancer treatment.

Methods

This cost-effectiveness analysis was based on data from a randomized phase III trial (SELECT BC). As cost-effectiveness was a secondary endpoint of the SELECT BC trial, some of the randomized patients participated in an EQ-5D survey (N = 391) and health economic survey (N = 146). The EQ-5D responses, claims, and prescription data were collected for as long as possible until death. The expected quality-adjusted life years (QALY) obtained from each treatment were calculated using patient-level EQ-5D data, and the expected cost was calculated using patient-level claim data. The analysis was performed from the perspective of public healthcare payers.

Results

The estimated EQ-5D least-square means and 95% CI up to 48 months were 0.764 (95% CI, 0.741–0.782) and 0.742 (95% CI, 0.720–0.764) in the S-1 and taxane arms, respectively. The expected QALY was 2.11 for the S-1 arm and 2.04 for the taxane arm, with expected costs of JPY 5.13 million (USD 46,600) and JPY 5.56 million (USD 50,500), respectively. These results show that S-1 is cost-saving. According to probabilistic sensitivity analysis, S-1 was dominant with a probability of 63%. When the willingness to pay (WTP) value was JPY 5 million (USD 45,500) per QALY, the probability of being cost-effective was 92%.

Conclusions

Our results show that the introduction of oral S-1 therapy for metastatic breast cancer is highly likely to be cost-effective.

Trial registration

UMIN CTR C000000416. Registered on May 10, 2006.
Appendix
Available only for authorised users
Literature
3.
go back to reference Squires H, Stevenson M, Simpson E, Harvey R, Stevens J. Trastuzumab Emtansine for treating HER2-positive, Unresectable, locally advanced or metastatic breast cancer after treatment with Trastuzumab and a Taxane: an evidence review group perspective of a NICE single technology appraisal. PharmacoEconomics. 2016;34(7):673–80.CrossRefPubMed Squires H, Stevenson M, Simpson E, Harvey R, Stevens J. Trastuzumab Emtansine for treating HER2-positive, Unresectable, locally advanced or metastatic breast cancer after treatment with Trastuzumab and a Taxane: an evidence review group perspective of a NICE single technology appraisal. PharmacoEconomics. 2016;34(7):673–80.CrossRefPubMed
4.
go back to reference Wade R, Duarte A, Simmonds M, Rodriguez-Lopez R, Duffy S, Woolacott N, Spackman E. The clinical and cost effectiveness of Aflibercept in combination with Irinotecan and fluorouracil-based therapy (FOLFIRI) for the treatment of metastatic colorectal cancer which has progressed following prior Oxaliplatin-based chemotherapy: a critique of the evidence. PharmacoEconomics. 2015;33(5):457–66.CrossRefPubMed Wade R, Duarte A, Simmonds M, Rodriguez-Lopez R, Duffy S, Woolacott N, Spackman E. The clinical and cost effectiveness of Aflibercept in combination with Irinotecan and fluorouracil-based therapy (FOLFIRI) for the treatment of metastatic colorectal cancer which has progressed following prior Oxaliplatin-based chemotherapy: a critique of the evidence. PharmacoEconomics. 2015;33(5):457–66.CrossRefPubMed
5.
go back to reference Greenhalgh J, Bagust A, Boland A, Oyee J, Trevor N, Beale S, Dundar Y, Hockenhull J, Proudlove C, O'Reilly S. Eribulin for the treatment of advanced or metastatic breast cancer: a NICE single technology appraisal. PharmacoEconomics. 2015;33(2):137–48.CrossRefPubMed Greenhalgh J, Bagust A, Boland A, Oyee J, Trevor N, Beale S, Dundar Y, Hockenhull J, Proudlove C, O'Reilly S. Eribulin for the treatment of advanced or metastatic breast cancer: a NICE single technology appraisal. PharmacoEconomics. 2015;33(2):137–48.CrossRefPubMed
6.
7.
go back to reference Takashima T, Mukai H, Hara F, Matsubara N, Saito T, Takano T, Park Y, Toyama T, Hozumi Y, Tsurutani J, et al. Taxanes versus S-1 as the first-line chemotherapy for metastatic breast cancer (SELECT BC): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2016;17(1):90–8.CrossRefPubMed Takashima T, Mukai H, Hara F, Matsubara N, Saito T, Takano T, Park Y, Toyama T, Hozumi Y, Tsurutani J, et al. Taxanes versus S-1 as the first-line chemotherapy for metastatic breast cancer (SELECT BC): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2016;17(1):90–8.CrossRefPubMed
9.
go back to reference Gradishar WJ, Anderson BO, Balassanian R, Blair SL, Burstein HJ, Cyr A, Elias AD, Farrar WB, Forero A, Giordano SH, et al. Breast cancer, version 1.2016. J Natl Compr Cancer Netw. 2015;13(12):1475–85.CrossRef Gradishar WJ, Anderson BO, Balassanian R, Blair SL, Burstein HJ, Cyr A, Elias AD, Farrar WB, Forero A, Giordano SH, et al. Breast cancer, version 1.2016. J Natl Compr Cancer Netw. 2015;13(12):1475–85.CrossRef
11.
go back to reference Tsuchiya A, Ikeda S, Ikegami N, Nishimura S, Sakai I, Fukuda T, Hamashima C, Hisashige A, Tamura M. Estimating an EQ-5D population value set: the case of Japan. Health Econ. 2002;11(4):341–53.CrossRefPubMed Tsuchiya A, Ikeda S, Ikegami N, Nishimura S, Sakai I, Fukuda T, Hamashima C, Hisashige A, Tamura M. Estimating an EQ-5D population value set: the case of Japan. Health Econ. 2002;11(4):341–53.CrossRefPubMed
12.
go back to reference Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA task force report. Value Health. 2005;8(5):521–33.CrossRefPubMed Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA task force report. Value Health. 2005;8(5):521–33.CrossRefPubMed
13.
go back to reference Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, Briggs A, Sullivan SD. Cost-effectiveness analysis alongside clinical trials II-an ISPOR good research practices task force report. Value Health. 2015;18(2):161–72.CrossRefPubMed Ramsey SD, Willke RJ, Glick H, Reed SD, Augustovski F, Jonsson B, Briggs A, Sullivan SD. Cost-effectiveness analysis alongside clinical trials II-an ISPOR good research practices task force report. Value Health. 2015;18(2):161–72.CrossRefPubMed
14.
go back to reference Weinstein MC, O'Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, Luce BR. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR task force on good research practices--modeling studies. Value Health. 2003;6(1):9–17.CrossRefPubMed Weinstein MC, O'Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, Luce BR. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR task force on good research practices--modeling studies. Value Health. 2003;6(1):9–17.CrossRefPubMed
15.
go back to reference Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Mak. 1993;13(4):322–38.CrossRef Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Mak. 1993;13(4):322–38.CrossRef
16.
go back to reference Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.CrossRefPubMed Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.CrossRefPubMed
17.
go back to reference Rasanen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R. Use of quality-adjusted life years for the estimation of effectiveness of health care: a systematic literature review. Int J Technol Assess Health Care. 2006;22(2):235–41.CrossRefPubMed Rasanen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R. Use of quality-adjusted life years for the estimation of effectiveness of health care: a systematic literature review. Int J Technol Assess Health Care. 2006;22(2):235–41.CrossRefPubMed
18.
go back to reference Wisloff T, Hagen G, Hamidi V, Movik E, Klemp M, Olsen JA. Estimating QALY gains in applied studies: a review of cost-utility analyses published in 2010. PharmacoEconomics. 2014;32(4):367–75.CrossRefPubMedPubMedCentral Wisloff T, Hagen G, Hamidi V, Movik E, Klemp M, Olsen JA. Estimating QALY gains in applied studies: a review of cost-utility analyses published in 2010. PharmacoEconomics. 2014;32(4):367–75.CrossRefPubMedPubMedCentral
19.
go back to reference Aihara T, Toyama T, Takahashi M, Yamamoto Y, Hara F, Akabane H, Fujisawa T, Ishikawa T, Nagai S, Nakamura R, et al. The Japanese breast cancer society clinical practice guideline for systemic treatment of breast cancer, 2015 edition. Breast cancer (Tokyo, Japan). 2016;23(3):329–42.CrossRef Aihara T, Toyama T, Takahashi M, Yamamoto Y, Hara F, Akabane H, Fujisawa T, Ishikawa T, Nagai S, Nakamura R, et al. The Japanese breast cancer society clinical practice guideline for systemic treatment of breast cancer, 2015 edition. Breast cancer (Tokyo, Japan). 2016;23(3):329–42.CrossRef
20.
go back to reference Shiroiwa T, Fukuda T, Ikeda S, Takura T, Moriwaki K. Development of an official guideline for the economic evaluation of drugs/medical devices in Japan. Value Health. 2017;20(3):372–8.CrossRefPubMed Shiroiwa T, Fukuda T, Ikeda S, Takura T, Moriwaki K. Development of an official guideline for the economic evaluation of drugs/medical devices in Japan. Value Health. 2017;20(3):372–8.CrossRefPubMed
21.
go back to reference Lin DY, Feuer EJ, Etzioni R, Wax Y. Estimating medical costs from incomplete follow-up data. Biometrics. 1997;53(2):419–34.CrossRefPubMed Lin DY, Feuer EJ, Etzioni R, Wax Y. Estimating medical costs from incomplete follow-up data. Biometrics. 1997;53(2):419–34.CrossRefPubMed
22.
go back to reference Lord J, Asante MA. Estimating uncertainty ranges for costs by the bootstrap procedure combined with probabilistic sensitivity analysis. Health Econ. 1999;8(4):323–33.CrossRefPubMed Lord J, Asante MA. Estimating uncertainty ranges for costs by the bootstrap procedure combined with probabilistic sensitivity analysis. Health Econ. 1999;8(4):323–33.CrossRefPubMed
23.
24.
go back to reference Shiroiwa T, Sung YK, Fukuda T, Lang HC, Bae SC, Tsutani K. International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness? Health Econ. 2010;19(4):422–37.CrossRefPubMed Shiroiwa T, Sung YK, Fukuda T, Lang HC, Bae SC, Tsutani K. International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness? Health Econ. 2010;19(4):422–37.CrossRefPubMed
25.
go back to reference WHO Collaborating Centre for Drug Statistics Methodology: Guidelines for ATC classification and DDD assignment, 6th edition edn. Oslo; 2003. WHO Collaborating Centre for Drug Statistics Methodology: Guidelines for ATC classification and DDD assignment, 6th edition edn. Oslo; 2003.
26.
go back to reference Shiroiwa T, Fukuda T, Shimozuma K, Mouri M, Hagiwara Y, Doihara H, Akabane H, Kashiwaba M, Watanabe T, Ohashi Y, et al. Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. Qual Life Res. 2017;26(2):445–53.CrossRefPubMed Shiroiwa T, Fukuda T, Shimozuma K, Mouri M, Hagiwara Y, Doihara H, Akabane H, Kashiwaba M, Watanabe T, Ohashi Y, et al. Long-term health status as measured by EQ-5D among patients with metastatic breast cancer: comparison of first-line oral S-1 and taxane therapies in the randomized phase III SELECT BC trial. Qual Life Res. 2017;26(2):445–53.CrossRefPubMed
27.
go back to reference Sculpher MJ, Claxton K, Drummond M, McCabe C. Whither trial-based economic evaluation for health care decision making? Health Econ. 2006;15(7):677–87.CrossRefPubMed Sculpher MJ, Claxton K, Drummond M, McCabe C. Whither trial-based economic evaluation for health care decision making? Health Econ. 2006;15(7):677–87.CrossRefPubMed
28.
go back to reference Morton A, Adler AI, Bell D, Briggs A, Brouwer W, Claxton K, Craig N, Fischer A, McGregor P, van Baal P. Unrelated future costs and unrelated future benefits: reflections on NICE guide to the methods of technology appraisal. Health Econ. 2016;25(8):933–8.CrossRefPubMed Morton A, Adler AI, Bell D, Briggs A, Brouwer W, Claxton K, Craig N, Fischer A, McGregor P, van Baal P. Unrelated future costs and unrelated future benefits: reflections on NICE guide to the methods of technology appraisal. Health Econ. 2016;25(8):933–8.CrossRefPubMed
Metadata
Title
Cost-effectiveness analysis of the introduction of S-1 therapy for first-line metastatic breast cancer treatment in Japan: results from the randomized phase III SELECT BC trial
Authors
Takeru Shiroiwa
Takashi Fukuda
Kojiro Shimozuma
Mitsuko Mouri
Yasuhiro Hagiwara
Takuya Kawahara
Shozo Ohsumi
Yasuo Hozumi
Yoshiaki Sagara
Yasuo Ohashi
Hirofumi Mukai
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3774-7

Other articles of this Issue 1/2017

BMC Cancer 1/2017 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine