Abstract
The 21-gene reverse transcriptase-polymerase chain reaction assay with a patented algorithm is validated as a good predictor of prognosis and potential benefit from adjuvant chemotherapy for lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer, while its high cost raises concern about how to finance it. Cost-effectiveness analysis comparing prevalent National Comprehensive Cancer Network (NCCN) guideline/St Gallen recommendation-guided treatment with the assay-guided treatment is carried out with budget impact estimation in the context of Japan’s health care system. Incremental cost-effectiveness ratios are estimated as 2,997,495 ¥/QALY (26,065 US$/QALY) in the comparison between NCCN guided-treatment vs. the assay-guided treatment, and as 1,239,055 ¥/QALY (10,774 US$/QALY) in the comparison between St Gallen guided-treatment vs. the assay-guided treatment. Budget impact is estimated as ¥2,638 million (US$23 million) to ¥3,225 million (US$28 million) per year. The routine use of the assay is indicated as cost-effective. And the budget impact could be judged as within fundable level.
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References
Kondo M, Toi M (2006) Cost-effective treatment options in first-line therapy for advanced breast cancer in Japan. Expert Rev Anticancer Ther 6(2):197–204
Miya T (2007) Current status and problems of tailor-made medicine in anticancer therapy. Gan To Kagaku Ryoho 34(4):515–519
Goldhirsch A, Wood WC, Gelber RD et al (2003) Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 21(17):3357–3365
Senn HJ, Thürlimann B, Goldhirsch A et al (2003) Comments on the St. Gallen consensus 2003 on the primary therapy of early breast cancer. Breast 12(6):569–582
Goldhirsch A, Glick JH, Gelber RD et al (2005) Meeting highlights: international expert consensus on the primary therapy of early breast cancer 2005. Ann Oncol 16(10):1569–1583
Goldhirsch A, Coates AS, Gelber RD et al (2006) First – select the target: better choice of adjuvant treatments for breast cancer patients. Ann Oncol 17(12):1772–1776
Early Breast Cancer Trialists’ Collaborative Group (2001) Tamoxifen for early breast cancer. Cochrane Database Syst Rev 2001(1):CD000486
Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365(9472):1687–1717
Carlson RW, McCormick B (2005) Update: NCCN breast cancer clinical practice guidelines. J Natl Compr Canc Netw 3(Suppl 1):S7–S11
Carlson RW, Brown E, Burstein HJ et al (2006) NCCN task force report: adjuvant therapy for breast cancer. J Natl Compr Canc Netw 4(Suppl 1):S1–S26
Carlson RW, Hudis CA, Pritchard KI et al (2006) Adjuvant endocrine therapy in hormone receptor-positive postmenopausal breast cancer: evolution of NCCN, ASCO, and St Gallen recommendations. J Natl Compr Canc Netw 4(10):971–979
Paik S, Shak S, Tang G et al (2004) A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 351(27):2817–2826
Paik S, Tang G, Shak S et al (2006) Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 24(23):3726–3734
Lacal JC (2007) How molecular biology can improve clinical management: the MammaPrint experience. Clin Transl Oncol 9(4):203
Drummond MF, Sculpher MJ, Torrance GW et al (2005) Methods for the economic evaluation of health care, 3rd edn. Oxford University Press, Oxford
The Japanese Breast Cancer Society (2007) Zenkoku nyugan kanja touroku chousa houkoku – kakuteiban—dai 35 gou 2004 nenji shourei (National breast cancer patient registry survey report – final report—No. 35 2004 cases). The Japanese Breast Cancer Society, Tokyo
Ohno Y, Nakamura T, Murata K et al (2004) Nihon no ganrikan no shoraisuikei – Bayes gata Poisson cohort model niyoru kaiseki ni motozuku 2020 nen madeno yosoku – (Future estimate of cancer incidence in Japan – Bayesian Poisson cohort model estimate until 2020). In: Oshima A, Ishiguro A, Tajima K (eds) Gan toukei hakusho – rikan, shibo, yogo – 2004 (Cancer statistics white paper – incidence, mortality, prognosis – 2004). Shinohara Shuppan Shinsha, Tokyo
van Oostenbruggen MF, Jansen RB, Mur K, Kooijman H (2005) Penny and pound wise: pharmacoeconomics from a governmental perspective. Pharmacoeconomics 23(3):219–226
Hornberger J, Cosler LE, Lyman GH (2005) Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer. Am J Manag Care 11(5):313–324. Erratum in: Am J Manag Care 11(8):476
Lyman GH, Cosler LE, Kuderer NM et al (2007) Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies. Cancer 109(6):1011–1018
Paik S, Shak S, Tang G et al (2004) Risk classification of breast cancer patients by the recurrence score assay: comparison to guidelines based on patient age, tumor size, and tumor grade. In: Abstracts of 27th annual San Antonio breast cancer symposium, Texas, 8–11 December 2004
Iwata H, Saeki T (2006) Current practices in breast cancer treatment in Japan – a questionnaire survey. Jpn J Breast Cancer 21(3):311–322
Japan Society of Clinical Oncology (2005) Kouganzai tekiseishiyou no gaidorain: nyuugan (Guideline of appropriate use of anti cancer drugs: breast cancer). Int J Clin Oncol 10(Suppl.):15–55
Japanese Breast Cancer Society (2006) Kagakuteki konkyo ni motozuku nyuugan sinryo gaidorain: 1 yakubutsu ryouhou 2006 nenban (Evidence-based breast cancer care guideline: 1 drug treatments 2006 version). Kanehara Shuppan, Tokyo
Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al (2005) Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 353(16):1659–1672
Smith I, Procter M, Gelber RD et al (2007) 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 369(9555):29–36
Elkin EB, Weinstein MC, Winer EP et al (2004) HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 22(5):854–863
Ministry of Health, Labour, Welfare (2007) The 20th life tables. Health and Welfare Statistics Association, Tokyo
Hillner BE, Smith TJ (1991) Efficacy and cost effectiveness of adjuvant chemotherapy in women with node-negative breast cancer. A decision-analysis model. N Engl J Med 324(3):160–168
Earle CC, Chapman RH, Baker CS et al (2000) Systematic overview of cost-utility assessments in oncology. J Clin Oncol 18(18):3302–3331
Cole BF, Gelber RD, Gelber S et al (2001) Polychemotherapy for early breast cancer: an overview of the randomised clinical trials with quality-adjusted survival analysis. Lancet 358(9278):277–286
Gold MR, Siegel JE, Russell LB et al (eds) Cost-effectiveness in health and medicine. Oxford University Press, New York
Iwata H, Nakamura S, Toi M et al (2005) Interim analysis of a phase II trial of cyclophosphamide, epirubicin and 5-fluorouracil (CEF) followed by docetaxel as preoperative chemotherapy for early stage breast carcinoma. Breast Cancer 12(2):99–103
Papaldo P, Ferretti G, Di Cosimo S et al (2006) Does granulocyte colony-stimulating factor worsen anemia in early breast cancer patients treated with epirubicin and cyclophosphamide? J Clin Oncol 24(19):3048–3055
Culyer AJ (2005) The dictionary of health economics. Edward Elgar, Cheltenham
Ohkusa Y (2003) Empirical research for the critical value of expenditure per QALY. Iryou to Shakai 13(3):121–130
Trueman P, Drummond M, Hutton J (2001) Developing guidance for budget impact analysis. Pharmacoeconomics 19(6):609–621
Shiroiwa T, Fukuda T, Shimozuma K et al (2007) The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res Treat (in press). doi:10.1007/s10549-007-9679-4
Drummond M, Pang F (2001) Transferability of economic evaluation results. In: Drummond M, McGuire A (eds) Economic evaluation in health care: merging theory with practice. Oxford University Press, Oxford
Toi M (2007) Update on the confirmatory Japanese study utilizing Oncotype DX. In: Abstracts of the 15th annual meeting of the Japanese breast cancer society, Kanagawa, 29–30 June 2007
Goldhirsch A, Wood W, Gelber R et al (2007) Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann Oncol 18(7):1133–1144
Lo SS, Norton J, Mumby PB et al (2007) Prospective multicenter study of the impact of the 21-gene recurrence score (RS) assay on medical oncologist (MO) and patient (pt) adjuvant breast cancer (BC) treatment selection. J Clin Oncol 25(18S):577
Goldstein LJ, Gray R, Childs BH et al (2007) Prognostic utility of 21-gene assay in hormone receptor (HR) positive operable breast cancer and 0–3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): an analysis of intergroup Trial E2197. J Clin Oncol 25(18S):526
Acknowledgements
This study is funded by Japan’s Ministry of Health, Labour and Welfare research grant, a study on the construction of algorithm of multimodality therapy with biomarkers for primary breast cancer by a formulation of decision making process, led by Masakazu Toi (H18-3JIGAN-IPPAN-007, H19-3JIGAN-IPPAN-007). Authors appreciate Dr Hiroji Iwata at Aichi Cancer Center for providing his survey data.
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Kondo, M., Hoshi, S.L., Ishiguro, H. et al. Economic evaluation of 21-gene reverse transcriptase-polymerase chain reaction assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer in Japan. Breast Cancer Res Treat 112, 175–187 (2008). https://doi.org/10.1007/s10549-007-9842-y
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DOI: https://doi.org/10.1007/s10549-007-9842-y