title: Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Clalit Health Services, Tel-Aviv, Israel.
authors.forename: Shmuel H
authors.initials: SH
authors.lastname: Klang
authors.forename: Ariel
authors.initials: A
authors.lastname: Hammerman
authors.forename: Nicky
authors.initials: N
authors.lastname: Liebermann
authors.forename: Noa
authors.initials: N
authors.lastname: Efrat
authors.forename: Julie
authors.initials: J
authors.lastname: Doberne
authors.forename: John
authors.initials: J
authors.lastname: Hornberger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology*; D017024:Chemotherapy, Adjuvant / Q000191:economics*; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D005260:Female; D020869:Gene Expression Profiling / Q000191:economics*; D005820:Genetic Testing / Q000191:economics*; D017048:Health Care Costs; D006801:Humans; D007557:Israel; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012008:Recurrence; D015203:Reproducibility of Results; D018570:Risk Assessment; D016019:Survival Analysis