An estimated 1.4 million women are using non-FDA-approved compounded bioidentical hormone therapy, which represents 40% of all menopausal hormone therapy prescriptions in the United States, according to data presented at the North American Menopause Society (NAMS) 2014 Annual Meeting.
In a study conducted by Sebastian Mirkin, MD, of TherapeuticsMD in Boca Raton, Florida, and colleagues, researchers sought to assess trends in the use of FDA-approved and non-FDA approved compounded menopausal hormone therapies since the publication of the Women’s Health Initiative (WHI) study through 2013.
“Although it has been previously reported that the use of FDA-approved [menopausal hormone therapy] decreased significantly following the publication of the WHI study, the usage of compounded non-FDA-approved [menopausal hormone therapy] has largely been unrecognized,” the researchers wrote in an abstract.
Notably, the fact that compounded prescriptions are not entered into a database like FDA-approved prescriptions is likely a major factor, they added.
Trends in Use
To gain insight into the overall use of both FDA-approved and compounded menopausal hormone therapy, Mirkin and colleagues evaluated prescription data from 1998 to 2013 from Source Healthcare Analytics, a 2014 Internet survey of women conducted by Rose Research and U.S. Census data from 2013.
The Rose survey included 90,210 women aged at least 40 years. There were 17.897 respondents, 2,044 of whom were current or former users of menopausal hormone therapy.
Results showed that about 5% of women aged 40 to 84 years used either FDA-approved or non-FDA approved compounded menopausal hormone therapy. Current use appeared to vary by age, with 6.5% of women aged 40 to 54 years, 4% of those aged 60 to 84 years and 2.9% of those aged 55 to 59 years using menopausal hormone therapy.
Further, ever use of menopausal hormone therapy was 24% in those aged 75 to 84 years, 7.7% in those aged 55 to 59 years and 13.5% in those aged 40 to 54 years, the researchers reported.
After the 2002 publication of the WHI study, use of menopausal hormone therapy declined from approximately 11% to 3% in postmenopausal women, with the most dramatic decrease occurring from 2002 to 2005. The drop-off leveled off from 2010 to 2013, according to the data.
Overall, the researchers estimated that at least 2% of women aged 40 to 84 years currently use compounded menopausal hormone therapy, which accounts for about 40% of all menopausal hormone therapy use in the United States.
“The growth of non-FDA approved compounded [menopausal hormone therapy] has occurred almost entirely following WHI,” the researchers wrote.
In a second study, JoAnn V. Pinkerton, MD, of the University of Virginia Health System in Charlottesville, and Nanette Santoro, MD, of the University of Colorado School of Medicine in Aurora, not only found that about 1.4 million women are using compounded bioidentical hormone therapy but that costs may be exceeding $1 billion annually.
They also found that many women lacked certain information about this form of treatment.
The researchers used also used data from the Rose survey as well as the Harris Interactive survey from July 2013. U.S. Census data and Source Healthcare Analytics PHAST 2.0 Prescription Data were also evaluated.
The Harris survey polled 10,781 women aged 45 to 60 years via email. There were 1,100 respondents, 801 of whom self-identified as menopausal and completed the survey. Questions on menopausal symptoms, hormone therapy use and knowledge of compounded bioidentical hormone therapy were included in both surveys.
Extrapolations of Rose data to the general population indicated that at least 3.6 million women in the U.S. use menopausal hormone therapy annually. Analyses suggested that 57 million prescriptions for menopausal hormone therapy may be filled annually — 21 million of which may be for compounded bioidentical hormone therapy.
According to responses from the Rose survey, the average amount paid for menopausal hormone therapy was $49, suggesting that more than $1 billion may be spent per year on compounded bioidentical hormone therapy, the researchers noted.
The two surveys yielded comparable results, indicating that 8% to 9% of respondents had used menopausal hormone therapy in the past and 5% to 6% were current users. The treatment was recommended by a physician for at least two-thirds of menopausal hormone therapy users in each survey, according to the data.
For Rose respondents, menopausal symptoms were the main reason for initiating (38%) or continuing treatment (43%). Twenty-one percent also thought their hormone therapy had been “specially formulated, personalized, or compounded” based on their individual hormone levels, the researchers reported. Twenty-seven percent, however, were unsure whether the treatment was custom-compounded.