SAN DIEGO – An estimated 26-33 million prescriptions for compounded, non–FDA-approved menopausal hormone therapy are filled in the United States each year, with annual sales reaching $1.3-$1.7 billion, results from a national pharmacist survey suggest.
What’s more, 69% of pharmacists expect their custom-compounded hormone therapy business to grow over the next 2 years.
“This is key, because if you expect that there’s nearly equivalent prescribing of compounded hormone therapy and menopausal hormone therapy, then it behooves us as care providers to make sure that [consumers] understand the difference between something that’s FDA approved, monitored, and regulated, and something that’s compounded, less well-regulated, and that is not FDA monitored or tested in rigorous clinical trials,” lead study author JoAnn Pinkerton said during a press briefing at the annual meeting of the Endocrine Society. “There are concerns about overdosing and under-dosing, sterility issues, the issue of batch-to-batch stability, and also the fact that if you get an FDA-approved product, you get a ‘black box’ warning of everything that’s been reported for HT [hormone therapy]. If you get a compounded product, they’re not required to give you any information about the risks. Many women are using these products. They’re being prescribed and we want people to be educated about the differences.”
Following the release of Women’s Health Initiative (WHI) data linking menopausal hormone therapy (MHT) to certain health risks, FDA-approved MHT users decreased from about 17.9 million in 2002 to about 3.7 million in 2013, said Dr. Pinkerton, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville. “This resulted in a marked increase in the compounded ‘bioidentical’ hormone therapy market primarily, we believe, because of a lot of hype that they might be safer, more effective, and that estriol might prevent breast cancer,” Dr. Pinkerton said. Specifically, the compounded ‘bioidentical’ hormone therapy (CHT) market has grown “from almost a negligible amount to about 2.5 million women, which is about 2% of U.S. women based on consumer surveys and U.S Census data. In earlier consumer surveys, most women who use these products were not aware that they are not FDA approved. There’s a knowledge gap for providers and women to learn about.”
For the study, Dr. Pinkerton and her associates evaluated results from an online national survey that was e-mailed to 12,250 independent community pharmacies and independent compounding pharmacies in the fall of 2014. Respondents “had to be knowledgeable of the annual revenue and the volume of compounded and noncompounded [prescriptions] at the pharmacy locations,” Dr. Pinkerton said. “We asked questions including the percentage of nonsterile compounding volume that is CHT, the percentage of monthly prescriptions for each type of CHT, and the likelihood of MHT prescribing over the next 2 years.”
Based on complete responses from 483 pharmacists, the researchers found that an estimated 26-33 million CHT prescriptions are filled each year, which is similar to the number of FDA-approved MHT prescriptions filled each year. In addition, based on an average compounded price of $50, the estimated sales of CHT currently range from $1.3 to $1.7 billion. More than half of compounding pharmacies (69%) expected demand for CHT to grow by 5%-25%. “Very few expected that the market would ‘explode,’ and very few thought that it would decrease,” Dr. Pinkerton said.
Dr. Pinkerton disclosed that she has received grants and research support (paid to the University of Virginia) from Pfizer, Inc., TherapeuticsMD, Noven, Shionogi, and TXMD.
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