title: Results of the Zometa cost-utility model for the german healthcare system based on the results of the ABCSG-12 study.
abstract: BACKGROUND
  The ABCSG-12 trial investigated the efficacy of gonadotropin-releasing hormone (GnRH)analogs in combination with tamoxifen or anastrozole + or - zoledronic acid (4 mg, q6m for 3 years) in 1,803 premenopausal women with hormone receptor-positive (HR+) breast cancer. After 48 months of follow-up, there was a 36% improvement in the disease-free survival (DFS) (recurrence-free survival 35%) using zoledronic acid. Based on these data, the costutility of zoledronic acid was calculated for the German healthcare system.
  
  
  METHODS
  Costs of surveillance, adverse effects, recurrence, contralateral breast cancer, metastasis, and end-of-life care were determined based on the Einheitlicher Bewertungsmabetastab (EBM 2009) and the diagnosis-related groups (DRG) system. Utilities were surveyed with a questionnaire (n = 95). Estimation of the cost-utility was made by calculating the incremental costeffectiveness ratio (ICER) per quality-adjusted life year (QALY), using a Markov model.
  
  
  RESULTS
  Including zoledronic acid as adjuvant therapy for 3 years resulted in total costs of euro 2,262. The use of zoledronic acid is dominant when clinical efficacy and quality of life are taken into consideration (- euro 45.83/QALY) (95% confidence interval (CI) - euro 1,838 to E 2,375; 0.02-0.41 QALY). The sensitivity analyses present with a probability of 90% that the cost per QALY gained are <euro 22,000.
  
  
  CONCLUSIONS
  In the German healthcare system, zoledronic acid is a cost-effective option for premenopausal patients with HR+ breast cancer.
authors.affiliation: Universitäts-Brustzentrum Franken, Frauenklinik, Universitätsklinikum Erlangen, Nürnberg, Germany. michael.lux@uk-erlangen.de
authors.forename: Michael P
authors.initials: MP
authors.lastname: Lux
authors.forename: Claudia
authors.initials: C
authors.lastname: Reichelt
authors.forename: Diethelm
authors.initials: D
authors.lastname: Wallwiener
authors.forename: Rolf
authors.initials: R
authors.lastname: Kreienberg
authors.forename: Walter
authors.initials: W
authors.lastname: Jonat
authors.forename: Michael
authors.initials: M
authors.lastname: Gnant
authors.forename: Matthias W
authors.initials: MW
authors.lastname: Beckmann
authors.forename: Falk C
authors.initials: FC
authors.lastname: Thiel
mesh_terms: D000077384:Anastrozole; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics* / Q000627:therapeutic use; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality; D003362:Cost-Benefit Analysis; D004164:Diphosphonates / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D016527:Drug Costs / Q000706:statistics & numerical data*; D005260:Female; D005858:Germany; D017273:Goserelin / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D008390:Markov Chains; D009010:Monte Carlo Method; D015337:Multicenter Studies as Topic; D009313:National Health Programs / Q000191:economics*; D009378:Neoplasms, Multiple Primary / Q000188:drug therapy / Q000191:economics / Q000401:mortality; D009570:Nitriles / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D013629:Tamoxifen / Q000191:economics* / Q000627:therapeutic use; D014230:Triazoles / Q000191:economics* / Q000627:therapeutic use; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D017273:Goserelin; D000077384:Anastrozole; D000077211:Zoledronic Acid