Aetna considers treatment of intractable, disabling primary hyperhidrosis with botulinum toxin type A (Botox), botulinum toxin type B (Myobloc) (see CPB 113 - Botulinum Toxin) or iontophoresis (see CPB 229 - Iontophoresis) (electrophoresis, Drionic device) medically necessary when all of the following criteria are met:
Topical aluminum chloride or other extra-strength antiperspirants are ineffective or result in a severe rash; and
Member is unresponsive or unable to tolerate at least one of the following pharmacotherapies prescribed for excessive sweating if sweating is episodic:anti-cholinergics, beta-blockers, or benzodiazapines; and
Significant disruption of professional and/or social life has occurred because of excessive sweating.
Aetna considers the following surgical treatments for hyperhidrosis medically necessary for members who meet the above-listed criteria (A through C) and have failed to adequately respond to treatment with iontophoresis (Note: a trial of botulinum toxin can be substituted for iontophoresis in persons with predominantly axillary hyperhidrosis):
Tumenescent liposuction for axillary hyperhidrosis
Excision of axillary sweat glands.
Aetna considers any of the following treatments for hyperhidrosis experimental and investigational because they have not been proven to be effective for this indication:
Psychotherapy
Hypnosis
Alternative therapy methods including homeopathy, massage, acupuncture and phytotherapeutic drugs.
Background
Sweating is a natural phenomenon necessary for the regulation of an individual's body temperature. Hyperhidrosis, or excessive sweating, is a medical condition that is defined as sweating beyond what is necessary to maintain thermal regulation.
Hyperhidrosis is classified as primary or secondary, depending on its cause or origin. Primary hyperhidrosis, also known as essential or idiopathic hyperhidrosis, is caused by an overactive sympathetic nervous system. It can lead to intractable and profuse sweating in several locations of the body, including palms (hands), axillae (armpits), and planta (feet). Secondary hyperhidrosis is the result of an underlying condition, such as Parkinson's disease, hyperthyroidism, diabetes mellitus, hyperpituitarism, pyrexia, hypoglycemia, or menopause. Secondary hyperhidrosis usually affects the whole body.
Regardless of the type or cause of hyperhidrosis, severe palmar and plantar hyperhidrosis can disrupt professional and social life and may lead to emotional problems. In the case of secondary hyperhidrosis, treatment of the underlying condition should first be attempted. In patients with disabling primary hyperhidrosis, a variety of treatment methods have been used.
The simplest method to control or reduce profuse sweating is the application of topical agents, such as aluminum chloride or other extra-strength chemical antiperspirants. Usually recommended as the first therapeutic measure, topical antiperspirants are effective in cases with light to moderate hyperhidrosis but have to be repeated regularly. Drysol (aluminum chloride hexahydrate) is a prescription topical antiperspirant commonly prescribed for excessive sweating. Drysol is reported to work in 80% of persons who use it for excessive sweating. Treatment is repeated nightly until sweating is under control. Thereafter, Drysol is applied once or twice weekly or as needed.
Oral prescription medications may be prescribed for situational or episodic hyperhidrosis, including anticholinergics (e.g., Robinul, Ditropan), beta-blockers (e.g., atenolol, propanolol), and benzodiazapines (e.g., Valium, Ativan). Anticholinergic medications may be effective for alleviating hyperhidrosis (ATTRACT, 2002: Altman and Kihiczak, 2002; GP Notebook, 2003). Anti-cholinergics such as propantheline bromide, glycopyrrolate, oxybutynin, and benztropine are effective because the pre-glandular neurotransmitter for sweat secretion is acetylcholine (although the sympathetic nervous system innervates the eccrine sweat glands). Some anticholinergics are better tolerated than others. Nyamekye (2004) states: "The most effective anticholinergic drug, glycopyrrolate (Robinul and Robinul Forte, Mikart, Inc., Pharmaceutical Manufacturers, Atlanta, GA) has mild side-effects and is generally well tolerated .... Topical glycopyrrolate has also been used in the treatment of localised secondary gustatory sweating." Adverse effects of anti-cholinergics include mydriasis, blurry vision, dry mouth and eyes, difficulty with micturition, and constipation. In addition, there is some evidence that other systemic medications, such as indomethacin and calcium channel blockers, may be beneficial in the treatment of palmoplantar hyperhidrosis (see, e.g., Feder, 1995; Eedy & Corbett, 1978; Tkach, 1982). Anxiolytics, sedatives, or beta-blockers (e.g., propranolol) may be helpful when history indicates that symptoms are precipitated or exacerbated by stress (see, e.g., Tyrer, 1998; Noyes, 1985; Fonte & Stevenson, 1985; GP Notebook, 2003).
Iontophoresis or electrophoresis can be tried if antiperspirants are not effective. Iontophoresis uses electric current to enhance drug penetration through the stratum corneum, the principal barrier to percutaneous absorption. Iontophoresis has been reported to provide temporary relief in mild cases of primary hyperhidrosis of the hands and feet. The procedure has to be repeated regularly, initially in 20-minute sessions several times a week, gradually stretching out the interval between treatments to 1-2 weeks. Treatments must be maintained indefinitely to control the symptoms of mild hyperhidrosis. The results vary: some many find the electric current uncomfortable and the treatments time consuming and not lasting long enough. The Drionic device (General Medical Co., Los Angeles, CA) is an iontophoretic device that can be purchased for home use.
Botulinum toxin type A (Botox) has been found to inhibit the release of acetylcholine not only at the neuromuscular junction, but also in post-ganglionic sympathetic fibers to sweat gland. It is indicated for the treatment of hyperhidrosis of the palms and axillae; intracutaneous injections of Botox have been shown to induce a temporary anhidrosis. Responses have been as long as 1 year, but in most cases the effect begins to weaken in 4 months. Although effective, the clinical usefulness of this treatment is limited by the need for multiple and repetitive relatively painful injections. The reports in clinical trials of increased palmer sweating in patients with axillary hyperhidrosis should also be noted, and it has not been reported in clinical trials whether this subsided as the effects of treatment wore off. In patients with palmer hyperhidrosis, another consideration might be the long-term effects on muscle tone, as weakness has been reported in the small muscles of the hands with botulinum toxin treatment (Bandolier, 2002).
In severe cases of intractable, disabling primary hyperhidrosis, surgical intervention has been utilized. The principle of sympathectomy is to interrupt the nerve tracks and nodes that transmit the signals to the sweat glands. This can basically be achieved for all locations in the body, but only the nerve nodes responsible for the sweat glands of the palms and the face are accessible without the need for a major surgical procedure. With the advent of minimally invasive endoscopic sympathectomy, open surgical sympathectomy or upper thoracic ganglionectomy at T2 -T4 has come into disfavor because of the magnitude of the procedure, the long periods of hospitalization and recovery, and the complication rate. Whether performed open or endoscopically, the most common side effect of surgery is compensatory hyperhidrosis characterized by a moderate increase in sweating in other parts of the body. A rare side effect is "gustatory sweating", a condition that leads to the sensation of sweating when eating. Another possible complication is Horner's syndrome resulting in a slightly smaller pupil and a slightly drooping eyelid on the affected side. The new technique of clipping the sympathetic nerve is generally viewed as the best option currently available because it is reversible by removing the nerve clip in patients with severe and unmanageable compensatory sweating. Lumbar sympathectomy, an open abdominal procedure, can cure isolated plantar hyperhidrosis; however, it is not usually employed because of the risk of sexual dysfunction.
Dressler and colleagues (2002) reported on a self-controlled study comparing the effectiveness of Botox and botulinum toxin type B in persons with bilateral axillary hyperhidrosis. A total of 19 subjects with axillary hyperhidrosis received botulinum toxin type B in one axilla and Botox in the other axilla. These investigators reported that all subjects except one reported excellent improvement in hyperhidrosis in both axillae, and that none of the subjects had residual hyperhidrosis on clinical examination. The duration of effect was not statistically significantly different between Botox and botulinum toxin type B.
In a randomized controlled clinical trial, Baumann and Halem (2004) reported on the use of botulinum toxin B in the treatment of patients with palmar hyperhidrosis. A total of 20 subjects with hyperhidrosis were randomly assigned to injection with botulinum toxin type B (n = 15) or placebo (n = 5). These researchers reported a significant difference in treatment response (as determined by participant assessment) between the subjects injected with botulinum toxin B and placebo. The duration of cessation of palmar sweating ranged from 2.3 months to 4.9 months, with a mean duration of 3.8 months. The authors stated, however, that 18 of 20 participants reported dry mouth/throat, 60 % reported indigestion/heartburn, 60 % reported muscle weakness, and 50 % reported decreased grip strength. These investigators concluded that botulinum toxin B was safe and effective in treating bilateral palmar hyperhidrosis. However, the side effect profile was substantial.
In a review on the use of botulinum toxins for the treatment of patients with hyperhidrosis and gustatory sweating syndrome, Glaser (2006) stated that both diseases respond very well to botulinum toxin therapy.
Surgical removal of sweat glands has been shown to be only effective in the treatment of axillary hyperhidrosis, and may leave significant scarring. For a person suffering from primary hyperhidrosis, this approach is usually only a partial solution to the problem, especially since the most annoying areas usually are the hands.
Poor results have been reported with the use of psychotherapy and hypnosis. Psychological problems are in most cases a consequence of hyperhidrosis, not the cause. Hence, psychiatric or psychopharmacologic therapy cannot cure this disorder; at most it may help the patient to accept living with the problem.
Alternative medicine interventions, including homeopathy, massage, acupuncture and phytotherapeutic drugs, have not been proven effective.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
11450
11451
15877
15878
32664
64650
64653
64802 - 64823
97033
CPT codes not covered for indication listed in the CPB:
90804 - 90857
90880
97124
97810 - 97814
HCPCS codes covered if selection criteria are met:
J0585
Botulinum toxin type A, per unit
J0587
Botulinum toxin type B, per 100 units
ICD-9 codes covered if selection criteria are met:
705.21
Primary focal hyperhidrosis
705.22
Secondary focal hyperhidrosis
Other ICD-9 codes related to the CPB:
691.8
Other atopic dermatitis and related conditions
692.9
Contact dermatitis and other eczema of unspecified cause
705.81 - 705.9
Other specified and unspecified disorders of sweat glands
780.8
Generalized hyperhidrosis
782.1
Rash and other nonspecific skin eruption
The above policy is based on the following references:
Naver Goh CL. Aluminum chloride hexahydrate versus palmar hyperhidrosis. Evaporimeter assessment. Int J Dermatol. 1990;29(5):368-370.
Glent-Madsen L, Dahl JC. Axillary hyperhidrosis. Local treatment with aluminium-chloride hexahydrate 25% in absolute ethanol with and without supplementary treatment with triethanolamine. Acta Derm Venereol. 1988;68(1):87-89.
Kramfilov T, Konrad H, Karte K, et al. Lower relapse rate of botulinum toxin A therapy for axillary hyperhidrosis by dose increase. Arch Dermatol. 2000;136(4):487-490.
H, Swartling C, Aquilonius SM. Palmar and axillary hyperhidrosis treated with botulinum toxin: One-year clinical follow-up. Eur J Neurol. 2000;7(1):55-62.
Heckmann M, Breit S, Ceballos-Baumann A, et al. Side-controlled intradermal injection of botulinum toxin A in recalcitrant axillary hyperhidrosis. J Am Acad Dermatol. 1999;41(6):987-990.
Odderson IR. Hyperhidrosis treated by botulinum A exotoxin. Dermatol Surg. 1998;24(11):1237-1241.
Solomon BA, Hayman R. Botulinum toxin type A therapy for palmar and digital hyperhidrosis. J Am Acad Dermatol. 2000;42(6):1026-1029.
U.S. Pharmacopoeial Convention, Inc. Botulinum toxin type A (parenteral-local). In: USP DI -- Drug Information for the Health Care Professional. 20th ed. Greenwood Village, CO: Micromedex; 2000.
Hashmonai M, Kopelman D, Assalia A. The treatment of primary palmar hyperhidrosis: A review. Surg Today. 2000;30(3):211-218.
Stolman LP. Treatment of hyperhidrosis. Dermatol Clin. 1998;16(4):863-869.
Reinauer S, Neusser A, Schauf G, et al. Iontophoresis with alternating current and direct current offset (AC/DC iontophoresis): A new approach for the treatment of hyperhidrosis. Br J Dermatol. 1993;129(2):166-169.
Grice K. Treating hyperhidrosis. Practitioner. 1988;232:953-956.
Akins DL, Meisenheimer JL, Dobson RL. Efficacy of the Drionic unit in the treatment of hyperhidrosis. J Am Acad Dermatol. 1987;26:828-832.
Lewis DR, Irvine CD, Smith FC, et al. Sympathetic skin response and patient satisfaction on long-term follow-up after thoracoscopic sympathectomy for hyperhidrosis. Eur J Vasc Endovasc Surg. 1998;15(3):239-243.
Krasna MJ, Demmy Tl, McKenna RJ, et al. Thoracoscopic sympathectomy: The U.S. experience. Eur J Surg Suppl. 1998;(580):19-21.
Shellow WR. Disturbances of skin hydration: Dry skin and excessive sweating. In: Goroll AH, Primary Care Medicine. 3rd ed. Philadelphia, PA: JB Lippincott Co; 1995:904-906.
Shenefelt PD. Hypnosis in dermatology. Arch Dermatol. 2000;136(3):393-399.
Swinehart JM. Treatment of axillary hyperhidrosis: Combination of the starch-iodine test with the tumescent liposuction technique. Dermatol Surg. 2000;26(4):392-396.
Payne CM, Doe PT. Liposuction for axillary hyperhidrosis. Clin Exp Dermatol. 1998;23(1):9-10.
Drott C, Claes G. Hyperhidrosis treated by thoracoscopic sympathicotomy. Cardiovasc Surg. 1996;4(6):788-791.
Noppen M, Vincken W, Dhaese J, et al. Thoracoscopic sympathicolysis for essential hyperhidrosis: Immediate and one year follow-up results in 35 patients and review of the literature. Acta Clin Belg. 1996;51(4):244-253.
Drott C, Gothberg G, Claes G. Endoscopic transthoracic sympathectomy: An efficient and safe method for the treatment of hyperhidrosis. J Am Acad Dermatol. 1995;33(1):78-81.
Atkins JL, Butler PE. Hyperhidrosis: A review of current management. Plast Reconstr Surg. 2002;110(1):222-228.
Togel B, Greve B, Raulin C. Current therapeutic strategies for hyperhidrosis: A review. Eur J Dermatol. 2002;12(3):219-223.
Alric P, Branchereau P, Berthet JP, et al. Video-assisted thoracoscopic sympathectomy for palmar hyperhidrosis: Results in 102 cases. Ann Vasc Surg. 2002;16(6):708-713.
Connolly M, de Berker D. Management of primary hyperhidrosis: A summary of the different treatment modalities. Am J Clin Dermatol. 2003;4(10):681-697.
Nyamekye IK. Current therapeutic options for treating primary hyperhidrosis. Eur J Vasc Endovasc Surg. 2004;27(6):571-576.
Eedy DJ, Corbett JR. Olfactory facial hyperhidrosis responding to amitriptyline. Clin Exp Dermtol. 1978;12:298-299.
Tkach JR. Indomethacin treatment of generalized hyperhidrosis. J Am Acad Dermatol. 1982;6:545.
Feder R. Clonidine treatment of excessive sweating. J Clin Psychiatry.1995; 56: 35.
Tyrer P. Current status of beta-blocking drugs in the treatment of anxiety disorders. Drugs. 1988;36(6):773-783.
Noyes R Jr. Beta-adrenergic blocking drugs in anxiety and stress. Psychiatr Clin North Am. 1985;8(1):119-132.
Fonte RJ, Stevenson JM. The use of propranolol in the treatment of anxiety disorders. Hillside J Clin Psychiatry. 1985;7(1):54-62.
Talarico-Filho S, Mendonca DO Nascimento M, Sperandeo DE Macedo F, DE Sanctis Pecora C. A double-blind, randomized, comparative study of two type A botulinum toxins in the treatment of primary axillary hyperhidrosis. Dermatol Surg. 2007;33(1 Spec No.):S44-S50.
Glogau RG. Topically applied botulinum toxin type A for the treatment of primary axillary hyperhidrosis: Results of a randomized, blinded, vehicle-controlled study. Dermatol Surg. 2007;33(1 Spec No.):S76-S80.
Lowe NJ, Glaser DA, Eadie N, et al; North American Botox in Primary Axillary Hyperhidrosis Clinical Study Group. Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: A 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety. J Am Acad Dermatol. 2007;56(4):604-611.
Malmivaara A, Kuukasjarvi P, Autti-Ramo I, et al. Effectiveness and safety of endoscopic thoracic sympathectomy for excessive sweating and facial blushing: A systematic review. Int J Technol Assess Health Care. 2007;2391):54-62.
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.