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Updated: Apr 30, 2026
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Published on: August 13, 2019
Economic return from the Women's Health Initiative estrogen plus progestin clinical trial: a modeling study
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.
Design:
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.
Data Sources:
Primary analyses of WHI outcomes, peer-reviewed literature, and government sources.
Target Population:
Postmenopausal women in the United States, aged 50 to 79 years, who did not have a hysterectomy.
Time Horizon:
2003 to 2012.
Perspective:
Payer.
Intervention:
Combined hormone therapy.
Outcome Measures:
Disease incidence, expenditure, quality-adjusted life-years, and net economic return.
Results Of Base-Case Analysis:
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 Of Sensitivity Analysis:
The 95% CI for the net economic return of the trial was $23.1 to $51.2 billion.
Limitation:
No evaluation of indirect costs or outcomes beyond 2012.
Conclusion:
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.
Primary Funding Source:
National Heart, Lung, and Blood Institute.
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