• Joshua A Roth, Ruth Etzioni, Teresa M Waters, Mary Pettinger, Jacques E Rossouw, Garnet L Anderson, Rowan T Chlebowski, Joann E Manson, Mark Hlatky, Karen C Johnson, and Scott D Ramsey.
• Ann. Intern. Med. 2014 May 6; 160 (9): 594602594-602.

BackgroundThe 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).ObjectiveTo estimate the economic return from the WHI E+P trial.DesignDecision 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.Data SourcesPrimary analyses of WHI outcomes, peer-reviewed literature, and government sources.Target PopulationPostmenopausal women in the United States, aged 50 to 79 years, who did not have a hysterectomy.Time Horizon2003 to 2012.PerspectivePayer.InterventionCombined hormone therapy.Outcome MeasuresDisease incidence, expenditure, quality-adjusted life-years, and net economic return.Results Of Base Case AnalysisThe 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 Of Sensitivity AnalysisThe 95% CI for the net economic return of the trial was $23.1 to $51.2 billion.LimitationNo evaluation of indirect costs or outcomes beyond 2012.ConclusionThe 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.Primary Funding SourceNational Heart, Lung, and Blood Institute.

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