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Clinical Challenges: Battling Insurers in Hyperhidrosis

— Some payers see condition as cosmetic

MedpageToday

While there are a number of options for the management of hyperhidrosis -- whether it be axillary, palmar, or of the soles of the feet -- insurance companies are often barriers to patients getting the most appropriate option.

"I'm going to be very frank here, what determines a lot of what we use is what the insurance will cover," Adelaide Hebert, MD, a dermatologist at the University of Texas Health McGovern Medical School in Houston, told 鶹ý. "It doesn't matter what we think, it's what the insurance company's going to pay for."

Treatment options vary from short-acting methods such as topical antiperspirants, oral anticholinergic agents, and iontophoresis, to longer-acting interventions such as botulinum toxin (Botox) or surgery with endoscopic thoracic sympathectomy (ETS).

"We often say, 'When there is no cure there are many treatments,' and that's the case here," said Hebert.

Every patient is a little different, she said, and the best approach is dependent on this. "I just listen to their history, talk with them about helping them design a program that's going to be helpful for them, and then we just go ahead and do that."

For patients with sweating in multiple areas, systemic anticholinergic drugs such as glycopyrrolate (Robinul) could be an option. But for those with solely axillary hyperhidrosis, or if their sweating in other anatomic regions isn't bothersome, then topical agents or botulinum toxin might be a better option.

Hebert was recently involved in the phase III ATMOS-1 and ATMOS-2 trials, data from which were presented at the American Academy of Dermatology annual meeting earlier this year and led to the FDA approval of glycopyrronium (Qbrexza) for the treatment of primary axillary hyperhidrosis in patients ages 9 and older.

"We do feel that this would be a very advantageous medication at first-line, but any new medicine that comes out, many companies just don't cover it," Hebert said, pointing out that pharmacy benefit managers and insurance companies will ultimately decide. "I'm not happy about that, but that's the reality."

ATMOS-1 found that 52.8% of patients reported 4-point improvements in sweating severity at 4 weeks with the glycopyrronium cloth -- based on the 11-point ASDD scale -- compared with 28.3% among patients who received towelettes with the drug vehicle only (P<0.001). Similarly, in ATMOS-2, the investigational arm reported improved sweat severity of 4 points or more (66.1% versus 26.9%, P<0.001).

But it's not just that new treatments are problematic for coverage. Insurer attitudes toward hyperhidrosis as a disease itself seem to be an issue as well.

"Some of the insurance companies -- especially UnitedHealthcare -- tend to consider this cosmetic and pay for very little coverage," said Hebert, noting that in many patients they won't pay for botulinum toxin beyond axillary sweating. "But it's not just a cosmetic problem, and I think that should be emphasized."

Hebert described her success using botulinum toxin off-label for hyperhidrosis affecting the palms, soles, face, back, and groin.

"There are many, many insurance challenges to making that happen," she said. "It's hours of work that go into a relatively quick procedure, but getting the medication to the patient is tremendously burdensome on the physician."

Regardless of the physician-preferred treatment, the same obstacle arises.

Eric Vallières, MD, a thoracic surgeon at the Swedish Cancer Institute in Seattle, told 鶹ý that he performs ETS for palmar hyperhidrosis on about 20% of the patients he sees.

"The main reason why people don't have surgery is because the insurance denies it," said Vallières. "Their insurance company will not pay for this procedure unless they have failed other conservative management."

A search of the literature reveals that little has changed in this regard for physicians treating palmar hyperhidrosis with ETS.

"Patients do not view a surgical procedure lightly," wrote Rafael Reisfeld, MD, of the Center for Hyperhidrosis in Los Angeles, in a 2006 letter to . "Therefore, it is extremely disturbing to see insurance carriers demanding that patients try any of these conservative methods for lengthy periods if they fail to help patients."

Reisfeld continued: "To allow the insurance industry to decide that patients must first try an unapproved (by the Food and Drug Administration) and unproven treatment for palmar hyperhidrosis before undergoing treatment that has been shown to be effective, that is in widespread use, and for which results have been published on thousands of patients should be unacceptable to the medical profession."

Disclosures

Hebert has disclosed institutional research funding and fees from various pharmaceutical companies.