WASHINGTON Drug Store News, for the simple reason that the change actually hurts the people health reform was supposed to help—patients looking to save money on healthcare costs. —The new prescription requirement for over-the-counter medicines under flexible spending accounts, part of the new Affordable Care Act, may amount to bad medicine, many industry pundits have told
And the ramifications of that simple requirement also will be felt across the retail pharmacies that those in search of healthcare savings patronize.
No matter how you slice it, consumers are looking at increased costs associated with using FSA plans under the new Affordable Care Act. It’s not that there will be any incremental lift in the number of practitioner visits, because no one really believes a consumer now will schedule a doctor’s appointment for the sole purpose of getting a prescription for an OTC. Similarly, no one expects a consumer not to follow through on an intended OTC purchase because it’s no longer reimbursed under FSA accounts without a prescription. But consumers no longer will be able to save against all of those acute care needs for which many consumers never really consult a family practitioner—minor diarrhea or stomach upset, for example, or cold symptom relievers.
Consumers also will be buying more OTC medicines going forward, whether they have an FSA account or not. “The biggest driver of OTC over the next few years [is] going to be individual insurance policy holders with high deductible insurance plans,” said Paul Keckley, executive director of the Deloitte Center for Health Solutions.
For those consumers who do consult their doctors about appropriate therapies, there may be an incremental lift in the number of appropriate prescription-only therapies prescribed to these patients versus the number of appropriate nonprescription remedies they may have otherwise taken on their own. For healthcare payers, that means a potential rise in covered costs, as prescription remedies by and large are more expensive than their OTC counterparts. And for retailers, this has the potential of shifting some of their business from the margin-friendly front-end to the paper-thin margins generated across their prescription sales.
For those consumers who do successfully follow through with a prescription for a nonprescription medicine, there’s the cost associated with adjudicating that prescription, a cost that many retailers expect to shoulder on their own. “About 30% of PBM formularies will actually cover an OTC drug… so the consumer will have just a co-pay,” said Jeff Beadle, executive director of SIGIS, an association that helps retailers manage FSA-eligible products through their POS platforms. “It seems that most merchants don’t charge a dispensing fee on those [OTC transactions].”
What’s more, at least in this first year of the rule changes, consumers will have less of a handle on what their actual annual health-care expenditures are. This will be the last year consumers can do any kind of end-of-the-year medicine-cabinet loading on non-prescription remedies in an effort to realize the full value of their FSA accounts. FSA accounts remain use-it-or-lose-it within one calendar year, so if a consumer overestimated his or her annual spend, at the end of 2011 he or she will be left with less-convenient measures of draining that FSA account, like scheduling an eye care appointment or doctor’s visit right in the middle of the hustle and bustle of holiday season.
Categories no longer eligible without a prescription
|Allergy and sinus medicine|
|Anti-itch and insect bite remedies|
|Baby rash ointments/creams|
|Cold sore remedies|
|Cough-cold and flu medicines|
|Feminine antifungal/anti-itch medicines|
|Motion sickness medication|
|Sleep aids and sedatives|
New report indicates times are a-changin’ for drug market
WHAT IT MEANS AND WHY IT’S IMPORTANT The drug industry is undergoing a major paradigm shift. Companies that traditionally have relied on blockbuster drugs are finding that model running dry as their biggest money-makers face competition from generics that eventually will lead to a heavily commoditized market for the disease states that have been the foundation for the model, such as high cholesterol, asthma, mental illness and gastroesophageal reflux disease.
(THE NEWS: IMS Health projects growth for Rx market. For the full story, click here)
In response, many are changing their focus to high-value specialty drugs, especially biotech drugs. For drug companies, it’s just their way of adapting to survive. But it’s also driving a shift in the world of pharmacy, feeding the growth of specialty pharmacy and, in turn, changing the role of the pharmacist in health care, all the while creating opportunities for retail pharmacies to embrace specialty pharmacy as a driver of growth as the “genericization” of pharmaceuticals threatens to dampen their sales figures.
It’s a trend that’s likely to continue. Pfizer’s acquisition of Wyeth, Merck’s acquisition of Schering-Plough, Roche’s acquisition of the remainder of Genentech and, most recently, Bristol-Myers Squibb’s acquisition of ZymoGenetics, as well as Sanofi-Aventis’ efforts to buy Genzyme, are just the largest examples of the pharma shift under way.
Supplements with natural S-equol may reduce joint pain, hot flashes in postmenopausal women
CHICAGO A new women’s health, whole soy germ-based nutritional supplement containing natural S-equol reduced the frequency of moderate to severe hot flashes and reduced muscle and joint pain in the first study of its kind among U.S. postmenopausal women, according to peer-reviewed data presented as a poster presentation at the North American Menopause Society Annual Meeting. Also, the first study to report natural S-equol contributions to bone health and a study of natural S-equol safety were presented at NAMS.
“These data from U.S. women expand our knowledge and corroborate previous research in Japanese women about the benefit of a supplement containing the soy-based compound natural S-equol to manage menopausal symptoms, including reducing the frequency of hot flashes and muscle discomfort,” stated Belinda Jenks, co-author of the U.S. women’s and safety studies, and director of scientific affairs and nutrition education at Pharmavite. “This and the other natural S-equol studies are part of the rigorous clinical collaborative program of Pharmavite and Otsuka to develop a supplement containing natural S-equol.”
S-equol is a compound resulting from the natural metabolism of daidzein, an isoflavone found in whole soybeans. Not everyone can produce S-equol after soy consumption, as the production depends on the types of bacteria present in the large intestine and may be influenced by the amount of soy consumed. About 50% of Asians and 20% to 30% of North Americans and Europeans, who in general consume less soy than Asians, have the ability to produce S-equol. Research indicated that Japanese women have milder menopausal symptoms in those who are S-equol producers compared with nonproducers.
All of the studies presented at NAMS used supplement tablets that contained natural S-equol. The SE5-OH is the product of fermentation of whole soy germ by the bacterial strain Lactococcus 20-92. The process results in the conversion of the daidzein to S-equol. SE5-OH is created under current good manufacturing practices. Following fermentation, the bacteria undergo heat denaturation and are deactivated. The process is designed to produce a natural S-equol rich product, or nutraceutical ingredient. The ingredient has self-affirmed GRAS status.
Otsuka Pharmaceutical supported all of the studies. Complete reports of data from each study will be submitted for peer-review publication, the companies stated.