title: Cost-effectiveness analysis of prognostic gene expression signature-based stratification of early breast cancer patients.
abstract: BACKGROUND
  The individual risk of recurrence in hormone receptor-positive primary breast cancer patients determines whether adjuvant endocrine therapy should be combined with chemotherapy. Clinicopathological parameters and molecular tests such as EndoPredict(®) (EPclin) can support decision making in patients with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative cancer.
  
  
  OBJECTIVE
  Using a life-long Markov state transition model, we determined the health economic impact and incremental cost effectiveness of EPclin-based risk stratification in combination with clinical guidelines [German-S3, National Comprehensive Cancer Center Network (NCCN), and St. Gallen] to decide on chemotherapy use.
  
  
  METHODS
  Information on overall and metastasis-free survival came from Austrian Breast & Colorectal Cancer Study Group clinical trials 6/8 (n = 1,619) and published literature. Effectiveness was assessed as quality-adjusted life-years (QALYs). Costs (2010) were assessed from a German third-party payer perspective.
  
  
  RESULTS
  Lifetime costs per patient ranged from <euro>28,268 (St.Gallen and EPclin) to <euro>33,756 (NCCN). Due to an imperfect prognostic value and differences in chemotherapy use, strategies achieved between 13.165 QALYs (NCCN) and 13.173 QALYs (EPclin alone) per patient. Using German-S3 as reference, three strategies showed dominant results (St. Gallen and EPclin, German-S3 and EPclin, EPclin alone). Compared to German-S3, the addition of EPclin saved <euro>3,388 and gained 0.002 QALYs per patient. Combining guidelines with EPclin remained preferable in sensitivity analysis.
  
  
  CONCLUSIONS
  Our study suggests that molecular markers can be sensibly combined with clinical guidelines to determine the risk profile of adjuvant breast cancer patients. Compared with the current German best practice (German-S3), combinations of EPclin with the St. Gallen, German-S3 or NCCN guideline and EPclin alone were dominant from the perspective of the German healthcare system.
authors.affiliation: Institute of Pharmaceutical Medicine (ECPM), University of Basel, Klingelbergstrasse 61, 4056, Basel, Switzerland, patricia.blank@unibas.ch.
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Blank
authors.forename: Martin
authors.initials: M
authors.lastname: Filipits
authors.forename: Peter
authors.initials: P
authors.lastname: Dubsky
authors.forename: Florian
authors.initials: F
authors.lastname: Gutzwiller
authors.forename: Michael P
authors.initials: MP
authors.lastname: Lux
authors.forename: Jan C
authors.initials: JC
authors.lastname: Brase
authors.forename: Karsten E
authors.initials: KE
authors.lastname: Weber
authors.forename: Margaretha
authors.initials: M
authors.lastname: Rudas
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.forename: Sibylle
authors.initials: S
authors.lastname: Loibl
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Szucs
authors.forename: Ralf
authors.initials: R
authors.lastname: Kronenwett
authors.forename: Matthias
authors.initials: M
authors.lastname: Schwenkglenks
authors.forename: Michael
authors.initials: M
authors.lastname: Gnant
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000191:economics / Q000235:genetics*; D017024:Chemotherapy, Adjuvant / Q000191:economics / Q000379:methods; D003362:Cost-Benefit Analysis; D005260:Female; D015972:Gene Expression Regulation, Neoplastic; D005858:Germany; D006801:Humans; D008390:Markov Chains; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D017410:Practice Guidelines as Topic; D011379:Prognosis; D019057:Quality-Adjusted Life Years; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen