Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Generalized Hyperhidrosis. 
Treatment:  Glycopyrrolate 2mg. 

The insurer denied the Glycopyrrolate 2mg.  The denial is overturned. 

The patient is a woman with hyperhidrosis for whom glycopyrrolate 2 mg (milligrams) is requested.  She has been on glycopyrrolate 2 mg (milligrams) with excellent results.  Prior to that, she failed Drysol, Hypercare, Botox and oxybutynin. 

Yes, the health plan should cover the Formulary Exception for Glycopyrrolate. 

The patient has been on oral glycopyrrolate with excellent results.  Glycopyrrolate and oxybutynin are the standard of care for hyperhidrosis, and she has failed oxybutynin in the past.  This is continuation of therapy with a medication that is standard of care in the industry, and it is medically necessary. 

The most common anticholinergic agents prescribed for primary focal hyperhidrosis are oral glycopyrrolate (glycopyrronium bromide) and oral oxybutynin.  Glycopyrrolate is utilized more frequently than oxybutynin.  However, only oxybutynin has been evaluated in randomized trials. 

Oral glycopyrrolate - The use of oral glycopyrrolate for hyperhidrosis is supported by retrospective case series.  In one retrospective series in which 45 patients with primary hyperhidrosis (axillary, palmoplantar, generalized, or craniofacial) received treatment with glycopyrrolate alone (11 patients) or in combination with local therapies (34 patients), 67 percent of patients reported symptomatic improvement.  In addition, a retrospective study of 31 children with hyperhidrosis (mean age of 15 years) found that 71 percent achieved major improvement in symptoms during treatment with glycopyrrolate (with or without concomitant topical aluminum chloride).  The children in this study were treated with an average total dose of 2 mg (milligrams) of glycopyrrolate per day.  Typical doses for adults range from 1 to 2 mg (milligrams) once or twice daily (i.e. [id est], 1 to 4 mg [milligrams] per day).  However, doses of up to 8 mg (milligrams) per day occasionally are required for improvement in symptoms. 

Oral oxybutynin - The efficacy of oxybutynin for hyperhidrosis was documented in a six-week randomized trial of 50 patients with palmar or axillary hyperhidrosis.  At six weeks, great or moderate improvement in symptoms occurred in 48 and 26 percent of patients treated with oxybutynin (2.5 mg [milligrams] per day for one week, 2.5 mg [milligrams] twice daily for two weeks, and 5 mg [milligrams] twice daily for three weeks), respectively.  In contrast, great or moderate improvement was reported by 0 and 27 percent of patients treated with placebo, respectively.  Uncontrolled studies performed by the same authors also support the efficacy of oxybutynin for facial, palmar, and axillary hyperhidrosis. 

In addition, a placebo-controlled randomized trial in which most study participants had generalized hyperhidrosis involving more than one body area (among palms, plantar feet, axillae, face, and trunk) demonstrated efficacy of oxybutynin for primary hyperhidrosis. Typical adult doses of oxybutynin are a total dose of 5 to 10 mg (milligrams) per day; this is given in two divided doses for immediate-release oxybutynin or once daily for extended-release oxybutynin.  However, doses up to 20 mg (milligrams) per day have been utilized. 

The formulary anticholinergics are not standard of care and not FDA (Food and Drug Administration)-approved for the treatment of hyperhidrosis.