title: Economic evaluation of intensive chemotherapy with prophylactic granulocyte colony-stimulating factor for patients with high-risk early breast cancer in Japan.
abstract: OBJECTIVE
  This study assessed the cost-effectiveness and budget impact of third-generation chemotherapy regimens with prophylactic granulocyte colony-stimulating factor (G-CSF) relative to second-generation regimens without prophylactic G-CSF for patients with high-risk early breast cancer in Japan.
  
  
  METHODS
  We conducted a cost-effectiveness analysis with Markov modeling and calculated incremental cost-effectiveness ratios (ICERs) for the comparison between second-generation regimens without prophylactic G-CSF and third-generation regimens with prophylactic G-CSF. The comparisons consisted of fluorouracil, doxorubicin, and cyclophosphamide, a second-generation regimen, versus docetaxel, doxorubicin, and cyclophosphamide (TAC) with G-CSF, a third-generation regimen; and doxorubicin, cyclophosphamide, and paclitaxel (AC-T) q3wk, a second-generation regimen, versus dose-dense (DD) AC-T q2wk with G-CSF, a third-generation regimen. Patients were stratified by the age at which chemotherapy was started into cohorts aged 35, 45, and 55 years. Outcomes were estimated in terms of life-years (LYs) and quality-adjusted LYs (QALYs). ICER calculations were done from a societal perspective. We also estimated the budget impact, which included the additional public medical expenditures that would cover all subsequent changes after the additional cost of choosing third-generation regimens if G-CSF were approved for use in third-generation regimens for breast cancer. Costs were calculated using prescription drug prices as of 2006.
  
  
  RESULTS
  Estimated ICER values for TAC with prophylactic G-CSF were yen956,471/LY and yen919,443/ QALY for age 35 years, yen1,125,540/LY and yen1,078,967/QALY for age 45 years, and yen1,302,746/LY and yen1,224,896/QALY for age 55 years. Values for DD AC-T q2wk with prophylactic G-CSF were yen291,931/LY and yen311,232/QALY for age 35 years, yen357,354/LY and yen380,148/QALY for age 45 years, and yen377,011/LY and yen399,761/QALY for age 55 years. TAC or DD AC-T q2wk with prophylactic G-CSF would yield cost savings compared with the respective second-generation regimens if the per-dose cost of G-CSF decreased from yen31,355 to yen15,700 (TAC) or to yen24,300 (DD AC-T). The estimated budget impact is yen9.5 to yen11.0 billion per year for the next 5 years.
  
  
  CONCLUSIONS
  According to a Markov model for patients with high-risk early breast cancer in Japan, third-generation regimens with prophylactic G-CSF will yield improved outcomes at a greater cost, but estimated ICER values are still less than the suggested cost-effectiveness threshold value of yen6 million (US $60,000, assuming US $1 = yen100) for a gain of 1 QALY.
authors.affiliation: Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishiguro
authors.forename: Masahide
authors.initials: M
authors.lastname: Kondo
authors.forename: Shu-Ling
authors.initials: SL
authors.lastname: Hoshi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takada
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D016527:Drug Costs; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000191:economics; D006801:Humans; D007564:Japan; D008390:Markov Chains; D008875:Middle Aged; D018803:Models, Economic; D009364:Neoplasm Recurrence, Local; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor