By Michael R. Cohen
Late last month the FDA approved a new drug called Oxytrol for Women - the first over-the-counter treatment for overactive bladder (OAB) in women ages 18 years and older. OAB symptoms include leaking urine (urinary incontinence), having a sudden and urgent need to urinate, and frequent urination. The condition is said to affect an estimated 33 million Americans, the majority of whom are older women.The drug, also available by prescription, is a skin patch that contains oxybutynin, which helps relax the bladder muscle.
I was pleased to learn that the new OTC product was approved since OAB can be an embarrassing, uncomfortable condition and studies showed that women could safely and independently use it. What’s interesting about this approval though is that as its name implies, the new OTC product was approved for use only by women, not men with the same symptoms.
The gender approval difference is because self-selection studies presented by Merck (the manufacturer of Oxytrol for women) found that fewer men and pregnant women correctly deemed the product was rightfor them than what the FDA determined was safe. In men, urinary frequency and urgency could be due to prostate disease where evaluation by a health care professional is needed. So a prostate cancer diagnosis could be delayed if men mistake the cause of their urination problems. FDA and the manufacturer rightly want men who suffer these symptoms to continue getting prescription Oxytrol.
Most often when a prescription drug moves to OTC status, it becomes available in a lower strength. Insurance companies will usually continue paying for the prescription strength medicine but deny payment for the lower strength OTC version. In this case though, Oxytrol for Women is the same strength and dosage form as the prescription product - 3.9 milligrams. So the current situation might result in men being reimbursed because they need a prescription, while women won’t for the OTC product, even though it’s the same exact drug.
It's not unheard of for insurance companies to cover some OTCs. Prilosec (omeprazole) and Prevacid (lansoprazole) are available OTC yet generic or higher strength versions are often covered if they are prescribed by a physician. Other examples include Allegra when it’s prescribed as fexofenadine, Zantac prescribed as ranitidine, and Azo (phenazopyridine). However, this situation isn’t quite like that since it isn’t a question of a branded OTC versus a less expensive generic.
Some payers also choose to pay for OTCs when it works to their advantage and somehow lowers overall costs.This makes sense if you consider that OTC medications are associated with self-management which can save on overall costs where benefit plans are based on covering professional health care services in general.
I suppose that women could continue asking their doctor for a prescription for the Rx-only product and I can also see how in the long run insurance companies might be pressured to cover it. But I can absolutely also see where a company might deny payment or require prior authorization for a woman with a prescription because an OTC version is now approved. I also suppose that men with OAB won’t be stopped from buying Oxytrol for Women. It certainly won’t be marketed that way and product labeling will hopefully warn against it. I hope my pharmacist colleagues will also watch for this.
Oxytrol for Women won’t actually be available until this coming September. So it’s not surprising that so far I haven’t been able to get an answer about coverage from any of the pharmacy benefit managers or insurance companies I’ve called. Nor has Merck or the FDA been able to answer this question. It should be very interesting to see how this plays out.