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Ann Intern Med. 2014 May 6;160(9):594-602. doi: 10.7326/M13-2348.

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.

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.

PMID:
24798522
[PubMed - indexed for MEDLINE]
PMCID:
PMC4157355
Free PMC Article
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