HEALTH

Bad medicine:

BY Michael Johnsen

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

Acid controllers
Allergy and sinus medicine
Antibiotics
Antidiarrheals
Antigas products
Anti-itch and insect bite remedies
Antiparasitic treatments
Baby rash ointments/creams
Cold sore remedies
Cough-cold and flu medicines
Digestive aids
Feminine antifungal/anti-itch medicines
Hemorrhoidal preps
Laxatives
Motion sickness medication
Pain relievers
Respiratory treatments
Sleep aids and sedatives
Stomach remedies
Source: SIGIS

 

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Obesity drug withdrawn following trial showing heart attack, stroke risk

BY Alaric DeArment

SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.

 

The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.

 

 

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achive on this drug to their risk of heart attack or stroke,” FDA office of new drugs director John Jenkins said. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight-loss maintenance programs.”

 

 

The FDA approved Meridia in 1997 for weight loss and maintenance of weight loss in obese people and some overweight people with other risks for heart disease, based on clinical trial data showing that people taking the drug lost at least 5% of their body weight compared with those taking placebo who relied on diet and exercise alone.

 

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Genzyme again rejects Sanofi buyout offer

BY Alaric DeArment

CAMBRIDGE, Mass. The board of directors of Genzyme again has rejected a buyout offer by French drug maker Sanofi-Aventis, Genzyme said Thursday.

The biotech company’s board unanimously turned down the hostile offer Sanofi made Monday to acquire Genzyme for $18.5 billion, or $69 per share, saying it was “opportunistic” and undervalued the company.

 

Specifically, Genzyme said Sanofi’s offer failed to recognize its late-stage development pipeline, which includes three drugs it plans to launch by the end of 2013, including alemtuzumab, a therapy for multiple sclerosis that the company said was “potentially transformative” and had potential to capture a significant share of the global MS market after its 2012 launch. The company also has pursued a plan to cut costs and improve manufacturing and other operations, which it said Sanofi’s deal did not take into account.

 

 

Genzyme focuses on therapies to treat such rare, genetic diseases as Fabry disease and Gaucher disease, but shortages of drugs used to treat those diseases –– such as Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase) –– arose last year due to product contamination issues at Genzyme’s manufacturing plants.

 

 

If successful, Sanofi’s acquisition of Genzyme would be among the largest in the industry since the wave of high-priced buyouts last year in which Pfizer bought Wyeth, Merck bought Schering-Plough and Roche bought the remaining stock of Genentech that it didn’t already own. In all three cases, the main objective was to gain access to the acquired companies’ significant portfolios and pipelines of specialty drugs, particularly biologics.

 

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