Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization

Shmuel H. Klang, Ariel Hammerman, Nicky Liebermann, Noa Efrat, Julie Doberne, John Hornberger

Research output: Contribution to journalArticlepeer-review


Objective: Oncotype DX, a 21-gene assay, was clinically validated as a predictor of 10-year recurrence-free survival and treatment response in patients with early-stage estrogen-receptor-positive, lymph-node negative breast cancer (ER+ LN- ESBC). This study determined "real-life" alteration in treatment decision and economic implications of Oncotype DX use in women with ER+ LN- ESBC. Methods: Clalit Health Services (CHS, Tel Aviv, Israel), determined the proportion of women in low, intermediate and high-risk groups in the first 368 Oncotype DX assays performed, the change of adjuvant therapy recommendation following the recurrence (RS) results from Oncotype DX use, and associated chemotherapy costs. The risk of recurrence-free survival was derived from prespecified statistical protocols of NCI-sponsored trials conducted by NSABP (B-14 and B-20). Utilities were literature based. A 3% discount rate was employed. Results: Oncotype DX altered recommendations of 40% of patients, 84% of whom were changed from hormone + chemotherapy to hormonal therapy alone. Among high-risk women, 8% switched actual treatment from hormonal therapy to hormone + chemotherapy. By reducing the chemotherapy disutility, quality-adjusted life-years (QALY) increased 0.170 years. Use of Oncotype DX costs $10,770 per QALY gained. Sensitivity analyses revealed that risk reduction in the low-risk population, the cost of adverse events, and the relative risk reduction of recurrence were the most influential variables. Conclusion: Oncotype DX resulted in net QALY gain and increased overall costs, with an incremental cost-effectiveness ratio of $10,770. For CHS, Oncotype DX represents an effective and affordable approach to favorably affect the lives of women with ESBC.

Original languageEnglish
Pages (from-to)381-387
Number of pages7
JournalValue in Health
Issue number4
StatePublished - 2010
Externally publishedYes

Bibliographical note

Funding Information:
Source of financial support: Teva Pharmaceutical Industries Ltd., Kiryat Nordau, Netanya, Israel.


  • Breast cancer
  • Oncotype DX
  • costs
  • early stage breast cancer
  • economics
  • gene assay
  • molecular classifier

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health Policy


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