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Health and Financial Analysis Supports NIH’s Decision to Fund Women’s Health Initiative

Program saves $35.2 billion in direct medical expenditures

An analysis of final data from one of the Women’s Health Initiative (WHI) Postmenopausal Hormone Therapy Trials has found that the investment in the WHI resulted in a return of $140 in net economic value for each dollar invested in the trial.

The WHI, sponsored by the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI), has followed women in the study since 1993. Results of the trial of estrogen plus progestin were published in 2002. A paper examining the national post-study long-term financial and health outcomes of the WHI was published May 5 in the Annals of Internal Medicine.

In assessing the return on investment, the researchers looked at disease incidence, direct medical expenditures, quality-adjusted life years (a measure of disease burden, including the quality and length of life), and net economic return between 2003 and 2012. The researchers’ analysis was based on a disease-simulation model that used an estimate of approximately 39.1 million women eligible for hormone therapy between 2003 and 2012. The analysis found that the guidance provided by the WHI clinical trial results led to:

  • 76,000 fewer cases of cardiovascular disease (i.e., coronary heart disease, coronary artery bypass graft/percutaneous transluminal coronary angioplasty, and stroke)
  • 4.3 million fewer combined hormone therapy users
  • 126,000 fewer breast cancer cases
  • 145,000 more quality-adjusted life years
  • Savings of $35.2 billion in direct medical expenditures

While most of the results were positive, the analysis did find that the guidance provided by the WHI clinical trial results led to 263,000 more fractures (hip, vertebral, and other osteoporotic fractures).

The researchers calculated the total net economic return of the trial, which cost $260 million in inflation-adjusted dollars, at $37.1 billion.

The WHI Hormone Therapy Trials studied 27,347 U.S. women aged 50 to 79 years who enrolled in 1993 and 1998. There were 16,608 women with an intact uterus in the trial of estrogen plus progestin and 10,739 without a uterus in the trial of estrogen alone. Women with an intact uterus were enrolled in the estrogen-plus-progestin trial because of the need to add progestin to the therapy to protect against endometrial cancer.

Source: NIH; May 5, 2014.

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Decision supported by data from more than 4,000 patients