Some people swear their restless legs won't stop moving. Others swear the syndrome is largely invented or, at the least,hyped to incredible levels. Whatever the creepy, crawly truth, a new FDA decision could slow the onslaught of Restless Leg Syndrome ads, MSNBC writes.
Last week, the agency approved the first generic versions of Glaxo's Requip for four manufacturers, and the move is likely to send Requip sales and advertising plummeting, industry experts predicted. At least one sleep disorder specialist expects the focus on the syndrome to fade as rapidly as the Requip television commercials - which have already been pulled from the airwaves.
“Restless legs syndrome is a great example of a suddenly out-of-the-blue disease,” Christopher Earley, an associate professor of neurology at Johns Hopkins University in Baltimore who treats the disorder, tells MSNBC. "I would anticipate there would be something of a fall-off," Earley said, adding: “I think we need to take the kettle off the stove and let it cool down a bit."
That prediction alarms patient advocates who have welcomed public attention for the little-known disorder first defined in 1945. “I think there certainly has been awareness about restless legs syndrome since the approval of (Reqiup) in 2005,” says Georgianna Bell, executive director of the Restless Legs Syndrome Foundation, which is funded by Glaxo and Boehringer Ingelheim.
If the generic switch leads to fewer ads, that should decrease patient demand for diagnosis and treatment, leaving only the most serious sufferers to weigh the benefits of the drugs against the risks of potentially severe side effects, MSNBC writes.
Whether the ads decline depends largely on the makers of Mirapex, the second-leading drug approved to treat restless legs syndrome, according to Lisa Schwartz, associate professor of medicine and community and family medicine at Dartmouth Medical School. “If it ends up that they pull back, the market might go down,” she tells MSNBC. A Boehringer spokesman declined to comment.
“This is going to be an interesting transition to follow. Folks may not be asking their docs for the once-highly-advertised drug to treat the leg twitch they were led to believe was a disease worthy of drug treatment,” Gary Schwitzer, an associate professor in the University of Minnesota School of Journalism and Mass Communication, writes to MSNBC. Docs may not be inclined to prescribe a drug if the supply of brand-name samples disappears. And the generics won’t come with samples, he notes.
3 Comments
Early on, the generics will also be expensive. Though four manufacturers may be enough critical mass to start some downward pressure on prices.
Interestingly, the grandparent of a patient of mine this very morning tried to ask me some questions about "restless leg." She didn't quite remember the Requip brand name. How long, I wonder, will it be before the memory of this condition and the advertising onslaught it spawned fades? In my opinion it can't be too soon - in my clinical life, I'm a pediatrician - I don't treat "RLS."
During the 180-day exclusivity period the first generic is typically priced only 15% or so below the brand's. After that, multiple suppliers drive the price down quickly to as great as 90% off. Interestingly, the 180-day period is where retail pharmacists can increase their operating profits substantially. Generally, in the months preceeding patent expiry the manufacturer aggressively raises prices recognizing market share will be lost but operating margin per unit will increase.
I did an unscientific price comparison at the local grocery-based pharmacy back in PA. The cash price of generic simvastatin was $124; Lipitor $97 and Crestor $107. Generic mevacor was $40/month--It's been off-patent quite a while. No generalizations should be made to prices paid by managed care, etc.
@Bob Freeman:
Was this recently that you priced simva? Or during the last half of 2006?
If this is recently, I find it hard to understand how that pharmacy is still in business. You can get lovastatin for $4/month from Wal-Mart and simvastatin from Costco for $7-15/month. And that's the cash price.