title: Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting.
abstract: OBJECTIVE
  The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2- early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany.
  
  
  METHODS
  A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually.
  
  
  RESULTS
  The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care.
  
  
  CONCLUSIONS
  Country-specific data on the risk of distant recurrence and quality-of-life were not available.
  
  
  CONCLUSIONS
  Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2- early-stage breast cancer.
authors.affiliation: St. Gertrauden-Krankenhaus, Berlin, Germany. jens.blohmer@sankt-gertrauden.de
authors.forename: J U
authors.initials: JU
authors.lastname: Blohmer
authors.forename: M
authors.initials: M
authors.lastname: Rezai
authors.forename: S
authors.initials: S
authors.lastname: Kümmel
authors.forename: T
authors.initials: T
authors.lastname: Kühn
authors.forename: M
authors.initials: M
authors.lastname: Warm
authors.forename: K
authors.initials: K
authors.lastname: Friedrichs
authors.forename: A
authors.initials: A
authors.lastname: Benkow
authors.forename: W J
authors.initials: WJ
authors.lastname: Valentine
authors.forename: W
authors.initials: W
authors.lastname: Eiermann
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000191:economics; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics*; D017024:Chemotherapy, Adjuvant / Q000191:economics*; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D003657:Decision Making; D005260:Female; D020869:Gene Expression Profiling; D005858:Germany; D005102:Health Expenditures / Q000706:statistics & numerical data; D006801:Humans; D008017:Life Expectancy; D008390:Markov Chains; D008875:Middle Aged; D017059:Models, Econometric; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000191:economics / Q000453:epidemiology; D019057:Quality-Adjusted Life Years; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D020133:Reverse Transcriptase Polymerase Chain Reaction
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases