Journal Article
. 2014 Sep;14().
doi: 10.1186/1472-6963-14-372.

Societal cost-effectiveness analysis of the 21-gene assay in estrogen-receptor-positive, lymph-node-negative early-stage breast cancer in Japan

Hideko Yamauchi  Chizuko Nakagawa  Shinji Yamashige  Hiroyuki Takei  Hiroshi Yagata  Atsushi Yoshida  Naoki Hayashi  John Hornberger 1 Tiffany Yu  Calvin Chao  Carl Yoshizawa  Seigo Nakamura  
Affiliations
  • PMID: 25190451
  •     26 References
  •     6 citations

Abstract

Background: Breast-cancer incidence and mortality have been increasing in Japan. Japanese-specific clinical validity and utility data for the 21-gene assay (Oncotype DX® Breast Cancer Assay; Genomic Health, Inc., Redwood City, USA) are now available. The objective of this study was to evaluate the cost-effectiveness of the 21-gene assay for the guidance of adjuvant chemotherapy decisions in estrogen-receptor-positive, lymph-node-negative, early-stage breast cancer patients, from the Japanese societal perspective.

Methods: The recurrence risk group distribution by the 21-gene assay result and the assay's influence on adjuvant chemotherapy recommendations were obtained from a study of 104 patients. A state-transition cohort (Markov) model tracked time from surgery until distant recurrence and from distant recurrence to death. Adjuvant chemotherapy benefit by 21-gene assay risk group was based on published clinical validation studies. Direct and indirect medical costs were obtained from the referral centers. Utilities associated with progression and chemotherapy-related adverse events were extracted from literature. Sensitivity analyses assessed the key drivers and robustness of the primary outcomes.

Results: The 21-gene assay identified 48% of patients as low-risk, 36% as intermediate-risk, and 16% as high-risk. Total acute chemotherapy-related costs decreased by ¥154,066 due to less adjuvant chemotherapy usage. In the high-risk group, adjuvant chemotherapy use increased 18%, leading to survival benefits. Chemotherapy use overall decreased by 19%. Monitoring costs increased by ¥3,744 but recurrence costs declined by ¥46,113 per patient. Use of the 21-gene assay increased quality-adjusted-life-years (QALYs) by 0.241 per patient on average; the net cost per QALY gained was ¥636,752 ($6,368).

Conclusions: The 21-gene assay for women with estrogen-receptor-positive, lymph-node-negative, early-stage breast cancer is projected to be cost-effective in Japan.

A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer.
J A Davidson, I Cromwell, +15 authors, S K Chia.
Eur J Cancer, 2013 Apr 25; 49(11). PMID: 23611660
Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20.
Gong Tang, Steven Shak, +6 authors, Norman Wolmark.
Breast Cancer Res Treat, 2011 Jan 12; 127(1). PMID: 21221771    Free PMC article.
Efficacy and cost effectiveness of adjuvant chemotherapy in women with node-negative breast cancer. A decision-analysis model.
B E Hillner, T J Smith.
N Engl J Med, 1991 Jan 17; 324(3). PMID: 1898533
Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer.
Daphne T Tsoi, Miho Inoue, +2 authors, Kathleen I Pritchard.
Oncologist, 2010 Apr 28; 15(5). PMID: 20421264    Free PMC article.
Economic evaluation of intensive chemotherapy with prophylactic granulocyte colony-stimulating factor for patients with high-risk early breast cancer in Japan.
Hiroshi Ishiguro, Masahide Kondo, +5 authors, Masakazu Toi.
Clin Ther, 2010 Mar 09; 32(2). PMID: 20206789
St. Gallen 2011: Summary of the Consensus Discussion.
Michael Gnant, Nadia Harbeck, Christoph Thomssen.
Breast Care (Basel), 2011 Jun 03; 6(2). PMID: 21633630    Free PMC article.
Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report.
Scott Ramsey, Richard Willke, +8 authors, Shelby Reed.
Value Health, 2005 Sep 24; 8(5). PMID: 16176491
Highly Cited. Review.
Frequency and cost of chemotherapy-related serious adverse effects in a population sample of women with breast cancer.
Michael J Hassett, A James O'Malley, +2 authors, Craig C Earle.
J Natl Cancer Inst, 2006 Aug 17; 98(16). PMID: 16912263
Highly Cited.
Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
Mitch Dowsett, Jack Cuzick, +11 authors, Steven Shak.
J Clin Oncol, 2010 Mar 10; 28(11). PMID: 20212256
Highly Cited.
Prospective study of the effect of the 21-gene assay on adjuvant clinical decision-making in Japanese women with estrogen receptor-positive, node-negative, and node-positive breast cancer.
Hideko Yamauchi, Chizuko Nakagawa, +7 authors, Seigo Nakamura.
Clin Breast Cancer, 2013 Dec 11; 14(3). PMID: 24321102
Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer.
C Lindley, S Vasa, W T Sawyer, E P Winer.
J Clin Oncol, 1998 Apr 29; 16(4). PMID: 9552041
Laboratory-developed test--SynFRAME: an approach for assessing laboratory-developed tests synthesized from prior appraisal frameworks.
John Hornberger, Julie Doberne, Rebecca Chien.
Genet Test Mol Biomarkers, 2012 Feb 04; 16(6). PMID: 22300513
Computer modeling of diabetes and its complications: a report on the Fourth Mount Hood Challenge Meeting.
Mount Hood 4 Modeling Group.
Diabetes Care, 2007 May 29; 30(6). PMID: 17526823
Ethical decision making and patient autonomy: a comparison of physicians and patients in Japan and the United States.
G W Ruhnke, S R Wilson, +6 authors, T A Raffin.
Chest, 2000 Oct 18; 118(4). PMID: 11035693
Evaluation of Oncotype DX Recurrence Score as a prognostic factor in Japanese women with estrogen receptor-positive, node-negative primary Stage I or IIA breast cancer.
Kyoko Yorozuya, Toru Takeuchi, +9 authors, Shogo Kikuchi.
J Cancer Res Clin Oncol, 2009 Dec 01; 136(6). PMID: 19946706
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
Soonmyung Paik, Gong Tang, +11 authors, Norman Wolmark.
J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680
Highly Cited.
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
Soonmyung Paik, Steven Shak, +12 authors, Norman Wolmark.
N Engl J Med, 2004 Dec 14; 351(27). PMID: 15591335
Highly Cited.
Quality of life valuations of mammography screening.
Amy E Bonomi, Denise M Boudreau, +4 authors, Deb Seger.
Qual Life Res, 2008 May 21; 17(5). PMID: 18491217
A cost utility analysis of mammography screening in Australia.
J Hall, K Gerard, G Salkeld, J Richardson.
Soc Sci Med, 1992 May 01; 34(9). PMID: 1631612
Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population.
Masakazu Toi, Hiroji Iwata, +8 authors, Japan Breast Cancer Research Group-Translational Research Group.
Cancer, 2010 Jun 22; 116(13). PMID: 20564629
Lifetime and age-conditional probabilities of developing or dying of cancer in Japan.
Ken-ichi Kamo, Kota Katanoda, +3 authors, Tomotaka Sobue.
Jpn J Clin Oncol, 2008 Jul 31; 38(8). PMID: 18664480
Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20.
Eleftherios P Mamounas, Gong Tang, +7 authors, Norman Wolmark.
J Clin Oncol, 2010 Jan 13; 28(10). PMID: 20065188    Free PMC article.
Highly Cited.
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
Kathy S Albain, William E Barlow, +20 authors, Breast Cancer Intergroup of North America.
Lancet Oncol, 2009 Dec 17; 11(1). PMID: 20005174    Free PMC article.
Highly Cited.
The Breast Cancer Working Group presentation was divided into three sections: the epidemiology, pathology and treatment of breast cancer.
Masakazu Toi, Yasuo Ohashi, +10 authors, Hiroko Bando.
Jpn J Clin Oncol, 2010 Oct 05; 40 Suppl 1. PMID: 20870914
Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features.
Lori J Goldstein, Robert Gray, +12 authors, Joseph A Sparano.
J Clin Oncol, 2008 Aug 06; 26(25). PMID: 18678838    Free PMC article.
Highly Cited.
Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03).
Masahide Kondo, Shu-Ling Hoshi, +2 authors, Masakazu Toi.
Breast Cancer Res Treat, 2010 Nov 18; 127(3). PMID: 21082239
Translational progress on tumor biomarkers.
Hongwei Guo, Xiaolin Zhou, +6 authors, Jian Zhang.
Thorac Cancer, 2015 Nov 12; 6(6). PMID: 26557902    Free PMC article.
Review.
Spotlight on the utility of the Oncotype DX® breast cancer assay.
Zhen Rong Siow, Richard H De Boer, Geoffrey J Lindeman, G Bruce Mann.
Int J Womens Health, 2018 Mar 06; 10. PMID: 29503586    Free PMC article.
Review.
Cost-Effectiveness Analyses of the 21-Gene Assay in Breast Cancer: Systematic Review and Critical Appraisal.
Shi-Yi Wang, Weixiong Dang, +3 authors, Cary P Gross.
J Clin Oncol, 2018 Apr 17; 36(16). PMID: 29659329    Free PMC article.
Systematic Review.
Cost-effectiveness of precision medicine: a scoping review.
Miriam Kasztura, Aude Richard, +2 authors, Antoine Flahault.
Int J Public Health, 2019 Oct 28; 64(9). PMID: 31650223    Free PMC article.
Systematic Review.
Direct medical and non-medical costs of a one-year care pathway for early operable breast cancer: Results of a French multicenter prospective study.
Delphine Héquet, Cyrille Huchon, +8 authors, Sandrine Baffert.
PLoS One, 2019 Jul 11; 14(7). PMID: 31291250    Free PMC article.
Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment.
Ontario Health (Quality).
Ont Health Technol Assess Ser, 2020 Apr 15; 20(10). PMID: 32284770    Free PMC article.