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

BMC Health Services Research

Seigo Nakamura³  Carl Yoshizawa¹  Calvin Chao¹  Tiffany Yu⁶  John Hornberger²  Naoki Hayashi⁴  Atsushi Yoshida⁴  Hiroshi Yagata⁴  Hiroyuki Takei⁷  Shinji Yamashige⁵  Chizuko Nakagawa⁴  Hideko Yamauchi⁴ 

[1] Genomic Health, Inc, Redwood City, CA, USA;School of Medicine, Stanford University, Stanford, CA, USA;Department of Breast Surgery, Showa University, Tokyo, Japan;Department of Breast Surgery, St. Luke’s International Hospitalcph, Tokyo, Japan;Graduate School of Economics, Hitotsubashi University, Tokyo, Japan;Cedar Associates LLC, Menlo Park, CA, USA;Division of Breast Surgery, Saitama Cancer Center, Saitama, Japan

关键词: Genetic testing;    Molecular diagnostic testing;    Cost-benefit;    Cost-effectiveness;    Breast cancer;   

Others  :  1126548
DOI  :  10.1186/1472-6963-14-372

 received in 2013-12-12, accepted in 2014-08-29,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Yamauchi et al.; licensee BioMed Central Ltd.

【 图 表 】

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