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.
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.
Authors: Alicia C Sasser; Maida Taylor; Howard G Birnbaum; Michael J Schoenfeld; Emily F Oster; Matthew Rousculp Journal: Expert Opin Pharmacother Date: 2005-09 Impact factor: 3.889
Authors: Jacqueline B Shreibati; JoAnn E Manson; Karen L Margolis; Rowan T Chlebowski; Marcia L Stefanick; Mark A Hlatky Journal: Am Heart J Date: 2017-12-27 Impact factor: 4.749
Authors: Joseph M Unger; Dawn L Hershman; Cathee Till; Catherine M Tangen; William E Barlow; Scott D Ramsey; Phyllis J Goodman; Ian M Thompson Journal: J Natl Cancer Inst Date: 2018-11-01 Impact factor: 13.506
Authors: Ross L Prentice; Aaron K Aragaki; Rowan T Chlebowski; Shanshan Zhao; Garnet L Anderson; Jacques E Rossouw; Robert Wallace; Hailey Banack; Aladdin H Shadyab; Lihong Qi; Beverly M Snively; Margery Gass; JoAnn E Manson Journal: Am J Epidemiol Date: 2020-09-01 Impact factor: 4.897
Authors: Irwin M Feuerstein; Marjorie R Jenkins; Susan G Kornstein; Michael S Lauer; Pamela E Scott; Tonse N K Raju; Tamara Johnson; Stephanie Devaney; Milena Lolic; Marsha Henderson; Janine Austin Clayton Journal: J Womens Health (Larchmt) Date: 2018-10 Impact factor: 2.681
Authors: Pamela P Pei; Milton C Weinstein; X Cynthia Li; Michael D Hughes; A David Paltiel; Taige Hou; Robert A Parker; Melanie R Gaynes; Paul E Sax; Kenneth A Freedberg; Bruce R Schackman; Rochelle P Walensky Journal: HIV Clin Trials Date: 2015-12-11
Authors: Richard R Fabsitz; George J Papanicolaou; Phyliss Sholinsky; Sean A Coady; Cashell E Jaquish; Cheryl R Nelson; Jean L Olson; Mona A Puggal; Kevin L Purkiser; Pothur R Srinivas; Gina S Wei; Michael Wolz; Paul D Sorlie Journal: Circulation Date: 2015-10-27 Impact factor: 29.690