Many women stop combination hormone replacement (HRT) therapy
But 57 percent continue HRT following health risk reports
ST. LOUIS, January 9, 2003 – A report issued today by pharmacy benefit manager Express Scripts (Nasdaq:ESRX) provides new information on the difficult choices women and their physicians began facing after the Journal of the American Medical Association (JAMA) published two studies questioning the relative safety of combination estrogen/progestin hormone replacement therapy (HRT) products.
In the four months following the July 2002 publication of the studies, 36 percent of women in a sample of Express Scripts members stopped using HRT combination products, more than four times the discontinuation rate during the same period the preceding year. On the other hand, 57 percent continued using the HRT combination products. HRT combination products include Premphase® and Prempro®. The remainder switched to other products.
"When new drugs come on the market, risks are usually better known for short term, rather than longer term, use. Now that the longer term risk of using HRT combination products is better understood, large numbers of women and their physicians acted promptly to avoid HRT and reduce their risk," said Raulo S. Frear, Pharm.D., Express Scripts' Vice President for Clinical Services.
Although the JAMA studies found no adverse effects among users of estrogen alone, 22.6 percent of Express Scripts member sample nevertheless discontinued use of any estrogen product and did not switch to a combination HRT product or to another agent used to treat osteoporosis. This was more than double the discontinuation rate of the previous year for the same period. Premarin® is an example of an estrogen-only product.
Yesterday, the U.S. Food and Drug Administration (FDA) required new safety warnings on labels of estrogen-containing products as a result of the studies which showed that women using HRT products were at higher risk of having coronary heart disease, strokes, and blood clots, according to the Women's Health Initiative (WHI) study conducted by the National Institutes of Health (NIH).
The FDA applied the new warning to all estrogen and progestin products, noting that all estrogen and progestin drug products work in similar ways. According to the agency, "until there are data that show otherwise, postmenopausal women who take any type of estrogen or progestin should be similarly warned about risks."
"The publication of these studies and the subsequent actions by the FDA indicate that future HRT treatment decisions should be based on individual therapy needs. Thorough discussion between patients and health care providers of the risks versus benefits of treatment options should take place prior to any treatment decisions," added Frear.
The combination HRT arm of the WHI was discontinued three years before the planned completion date after evidence accumulated that combination HRT failed to protect against CHD. In addition, women using it actually had higher risks of having CHD, strokes and blood clots. A higher risk of breast cancer was also seen in the WHI study participants.
The other study published by JAMA was a follow up to the Heart and Estrogen/Progestin Replacement Study called HERS II. This study showed that combination HRT was not effective in preventing CHD for older postmenopausal women with existing CHD.
The Express Scripts report on physician and member reaction to the HERS II findings was based on a sample of 372,777 Prempro, Premphase, Premarin and other estrogens, Evista, Fosamax and Actonel users 18 or older and who were continuously eligible in the Express Scripts commercial book of business between March 10, 2002 and November 10, 2002.
Utilization patterns of these users in the four month pre-period between March 10, 2002 and July 9, 2002 were compared to usage in the four month post-period from July10, 2002, to November 10, 2002. Then, these utilization patterns were compared to usage patterns of the same medicines for a sample 112,247 continuously eligible users of the same drugs 18 or older in the Express Scripts commercial book of business for similar periods in 2001.
For more than a decade, Express Scripts has employed a company-paid research staff, which now numbers fourteen professionals, five of whom hold PhDs. Many of the studies they conduct are published in peer-reviewed journals, reported in the national media and presented at scientific or professional conferences, including the annual Express Scripts Outcomes Conference held for clients. First published in 1996, the annual Express Scripts Drug Trend Report quickly earned national recognition as the most comprehensive, publicly available analysis of U.S. drug-cost trends. Express Scripts also conducted the first national study of regional variation in prescription-drug utilization patterns across the United States. More information about these and other studies are available at http://www.express-scripts.com/other/news_views/outcomes_research.htm.
One of the largest pharmacy benefit management (PBM) companies in North America, Express Scripts, Inc., makes prescription drugs more affordable and their use safer guided by a legacy of independence. Express Scripts provides integrated PBM services, including network pharmacy claims processing, mail pharmacy services, benefit design consultation, drug utilization review, formulary management, disease management, medical and drug data analysis services, medical information management services and informed decision counseling services through its Express Health Line(sm) division. The company also provides distribution services for specialty pharmaceuticals through its Specialty Distribution subsidiary and sampling services through its Phoenix Marketing Group subsidiary. Express Scripts is headquartered in St. Louis, Missouri. More information can be found at http://www.express-scripts.com, which includes expanded investor information and resources.