title: Economic return from the Women's Health Initiative estrogen plus progestin clinical trial: a modeling study.
abstract: BACKGROUND
  The findings of the Women's Health Initiative (WHI) estrogen plus progestin (E+P) trial led to a substantial reduction in use of combined hormone therapy (cHT) among postmenopausal women in the United States. The economic effect of this shift has not been evaluated relative to the trial's $260 million cost (2012 U.S. dollars).
  
  
  OBJECTIVE
  To estimate the economic return from the WHI E+P trial.
  
  
  METHODS
  Decision model to simulate health outcomes for a "WHI scenario" with observed cHT use and a "no-WHI scenario" with cHT use extrapolated from the pretrial period.
  
  
  METHODS
  Primary analyses of WHI outcomes, peer-reviewed literature, and government sources.
  
  
  METHODS
  Postmenopausal women in the United States, aged 50 to 79 years, who did not have a hysterectomy.
  
  
  METHODS
  2003 to 2012.
  
  
  CONCLUSIONS
  Payer.
  
  
  METHODS
  Combined hormone therapy.
  
  
  METHODS
  Disease incidence, expenditure, quality-adjusted life-years, and net economic return.
  
  
  RESULTS
  The WHI scenario resulted in 4.3 million fewer cHT users, 126,000 fewer breast cancer cases, 76,000 fewer cardiovascular disease cases, 263,000 more fractures, 145,000 more quality-adjusted life-years, and expenditure savings of $35.2 billion. The corresponding net economic return of the trial was $37.1 billion ($140 per dollar invested in the trial) at a willingness-to-pay level of $100,000 per quality-adjusted life-year.
  
  
  RESULTS
  The 95% CI for the net economic return of the trial was $23.1 to $51.2 billion.
  
  
  CONCLUSIONS
  No evaluation of indirect costs or outcomes beyond 2012.
  
  
  CONCLUSIONS
  The WHI E+P trial made high-value use of public funds with a substantial return on investment. These results can contribute to discussions about the role of public funding for large, prospective trials with high potential for public health effects.
  
  
  BACKGROUND
  National Heart, Lung, and Blood Institute.
authors.forename: Joshua A
authors.initials: JA
authors.lastname: Roth
authors.forename: Ruth
authors.initials: R
authors.lastname: Etzioni
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Waters
authors.forename: Mary
authors.initials: M
authors.lastname: Pettinger
authors.forename: Jacques E
authors.initials: JE
authors.lastname: Rossouw
authors.forename: Garnet L
authors.initials: GL
authors.lastname: Anderson
authors.forename: Rowan T
authors.initials: RT
authors.lastname: Chlebowski
authors.forename: Joann E
authors.initials: JE
authors.lastname: Manson
authors.forename: Mark
authors.initials: M
authors.lastname: Hlatky
authors.forename: Karen C
authors.initials: KC
authors.lastname: Johnson
authors.forename: Scott D
authors.initials: SD
authors.lastname: Ramsey
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D002986:Clinical Trials as Topic / Q000191:economics*; D015179:Colorectal Neoplasms / Q000453:epidemiology; D017046:Cost Savings; D003661:Decision Support Techniques; D015914:Estrogen Replacement Therapy; D005260:Female; D005380:Financing, Government; D050723:Fractures, Bone / Q000453:epidemiology; D005102:Health Expenditures; D006801:Humans; D015994:Incidence; D008390:Markov Chains; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control; D017698:Postmenopause; D019057:Quality-Adjusted Life Years; D014481:United States; D016387:Women's Health / Q000191:economics*