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PBS listing of revolutionary botulinum toxin treatment promises relief from axillary hyperhidrosis

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Botulinum toxin A (BTX-A, e.g. BotoxTM), a potent toxin with neuromuscular blocking properties, has gained prominence in the treatment of numerous neurological conditions.1 It was approved in many countries for the treatment of focal hyperhidrosis of the axillae in the first decade of the 21st century and has revolutionised treatment of this debilitating condition.2

Mounting evidence of the efficacy of botulinum toxin in treating axillary hyperhidrosis has led to the listing of BotoxTM for severe primary axillary hyperhidrosis under the Australian Pharmaceutical Benefits Scheme (PBS).3 This listing promises to minimise the financial constraints associated with accessing medicine4 which have to date limited the use of BTX-A for eligible patients.5 However, the long-term use of BTX-A is only one option for this indication, and BTX-A may not be so easy to use to treat other sites (e.g. hands, feet) commonly affected by hyperhidrosis.2

Increasing use of BTX-A for neurological conditions

BTX-A is a neuromuscular blocking agent which exerts its effect by inhibiting the peripheral release of the neurotransmitter acetylcholine. It is used to treat a range of neurological disorders such as focal dystonia including torticollis/writer’s cramp/laryngeal dystonia, spasticity, blepharospasm, hemifacial spasm, hypersalivation, strabismus, as well as some cosmetic indications.6 New indications for BTX-A treatment are emerging or under investigation. For example, the drug was TGA approved in Australia for the treatment of chronic migraine in 2011,6 and clinical trials have been conducted to assess its safety and efficacy in a number of new indications including ischaemic digits,7 bladder conditions,8 gastrointestinal disorders and pain management.1

Hyperhidrosis

Focal hyperhidrosis is a condition characterised by excessive perspiration at specific sites, most commonly the axillae, hands and feet.5 It is the result of a non-thermoregulatory sweat response9 which is thought to occur secondary to overactivity of the sympathetic nervous system.10 Sweat gland innervation pathways involve acetylcholine5 and in the treatment of hyperhidrosis, injection of BTX-A causes temporary denervation of the targeted sweat glands. In doing so it reduces sweat production.6 

Hyperhidrosis is a surprisingly common condition which has serious implications for patient wellbeing and quality of life.5 Epidemiological evidence suggests that 2.8% of the general population are affected,9 and the psychosocial impact of the symptoms of hyperhidrosis should not be underestimated. Patients report the condition interferes with daily activities and work productivity, and also impairs social life, for example by causing embarrassment and social phobia, and reducing self-confidence.11 Therefore, treating the condition and minimising its psychosocial impact are important treatment goals.12

Botulinum toxin A for axillary hyperhidrosis

BTX-A therapy has revolutionised treatment of axillary hyperhidrosis. It is a minimally invasive treatment which provides long-lasting (on average 6–7 months) relief.2 For example, one study reported that 75% of axillary hyperhidrosis patients experienced reduced sweating following BTX-A therapy.13 In axillary cases, injections can typically be administered without the need for anaesthesia. However, while BTX-A is highly effective in cases of plantar and palmar hyperhidrosis, its use is limited by the need for anaesthesia (sometimes a regional nerve block) for pain relief during administration.2

BTX-A is indicated as second-line treatment for severe focal hyperhidrosis affecting the axillae14 in patients aged > 12 years,6 and this indication has recently been listed on the PBS.3 In Australia, prescribers of BTX-A for axillary hyperhidrosis must have suitable qualifications (in dermatology, neurology or paediatrics), experience administering the drug, and be registered as authorised prescribers with Medicare in order for their patients to receive the PBS subsidy. Patients are eligible for treatment if they have failed to respond to first-line hyperhidrosis treatment with aluminium chloride containing anti-perspirants.3 Despite these restrictions, listing of BTX-A on the PBS promises to make the treatment more accessible for axillary hyperhidrosis patients. And, according to Dr Karl Ng, Consultant Neurologist at Royal North shore Hospital and Conjoint Senior Lecturer at the University of Sydney, awareness need not only be focused on cost.

“This is not just for the affordability of the treatment now from select specialists, but for the role of this drug that may not have been known to many primary care physicians before. Public awareness would also be enhanced for this prevalent condition which would be long overdue, encouraging sufferers to seek help,” he said.

Remaining limitations

However, access to the drug remains limited because of cost for hyperhidrosis patients with other body sites affected,3 including an estimated 60% of hyperhidrosis cases with excessive sweating of the hands, feet or both.2 BTX-A is also recommended for use as an off-label treatment for plantar, palmar and cranio-facial hyperhidrosis, when other therapies (e.g. iontophoresis, topical agents) fail,14 but the PBS listing does not cover these indications.3 However, once one main limitation has been addressed, there is hope that BTX-A may be subsidised for hyperhidrosis at other body sites as well.

“There appears little doubt that some patients who have tried other treatments would benefit from toxin injection to the palmar and plantar areas. The main drawback is the discomfort and a small risk of small hand muscle weakness. If this can be overcome, a case could be made for toxin treatment to be provided for by the PBS,” said Dr Ng.

Access to BTX-A is also limited for hyperhidrosis patients due to under-recognition and under-treatment of the condition. Many affected individuals are unaware they have a treatable medical condition.15 Only one-third of those affected receive treatment.9 Unless improved identification of hyperhidrosis occurs, the ability of BTX-A to treat the condition will remain limited. Dr Ng believes that many clinicians aren’t actually aware that this condition can be treated in this way.

“Many clinicians may have little or no experience in the investigation and management of hyperhidrosis, and unfortunately, a lot of patients have been told they just have to live with their symptoms,” said Dr Ng.

BTX-A versus surgical treatment for palmar and plantar hyperhidrosis

While the minimally invasive nature of BTX-A therapy is a revolutionary step forward in hyperhidrosis treatment, there remains significant debate regarding its role and that of surgery in the area of limb sweating. Botulinum toxin provides long-lasting but transient relief, while thoracic sympathectomy can be curative for palmar and plantar hyperhidrosis.16 Although the surgical procedure in some hands is highly effective and patient satisfaction with thoracic sympathectomy may be high, compensatory sweating often occurs at other sites after the majority of surgeries, as can recurrence of palmar sweating.17 The surgical procedure is also not without its complications. BTX-A treatment, although fairly free of complications, must be repeated. In reality, both BTX-A therapy and surgery have their role. Because of the invasive nature of surgery, it tends to be reserved as third-line treatment for axillary hyperhidrosis, where endoscopic sympathectomy is not that effective.

Conclusion

There is now a greater range of treatment options available for people who suffer from hyperhidrosis and, with the PBS listing of BTX-A for axillary hyperhidrosis, one key treatment is now much more affordable. Whether administration difficulties can be overcome to make this treatment more suitable for palmar and plantar hyperhidrosis remains to be seen.2 Considerable work is required to raise awareness of hyperhidrosis and ensure affected individuals discuss symptoms of excessive sweating with their healthcare provider and access the wider range of treatments now available.15

Many treatments, including curative surgery, are available for hyperhidrosis, and BTX-A therapy is now another treatment modality for this condition. BTX-A has demonstrated high efficacy and high patient satisfaction in treating axillary hyperhidrosis and now that the cost barrier has been removed, sufferers stand to gain significantly.

“Now, with PBS access to certain specialists such as neurologists who have the necessary training and certification, many patients who require this therapy can now access it more affordably,” Dr Ng said.

Therefore, listing of BTX-A with the PBS gives patients more affordable options than ever before and promises to revolutionise the treatment of hyperhidrosis in Australia.2

 

Sweating picture

For more information about the different types of hyperhidrosis, what body parts may be affected, treatment options and handy tips on living with this condition, see Hyperhidrosis.

 

 

Article kindly reviewed by:

Dr Karl Ng MB BS (Hons I) FRCP FRACP CCT Clinical Neurophysiology (UK)
Consultant Neurologist, Royal North Shore Hospital
Sydney North Neurology and Neurophysiology (download referral form and map) Conjoint Senior Lecturer, University of Sydney, licensed botulinum toxin injector, and Editorial Advisory Board Member of the Virtual Neuro Centre.

Dr Ng QR code


References

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  2. Benohanian A. What stands in the way of treating palmar hyperhidrosis as effectively as axillary hyperhidrosis with botulinum toxin type A? Dermatol J Online. 2009;15(4):12. [Abstract | Full text]
  3. Botulinum toxin [online]. Greenway, ACT: Medicare Australia; 30 November 2011 [cited 2 January 2012]. Available from: [URL link]
  4. Duckett SJ. Drug policy down under: Australia’s Pharmaceutical Benefits Scheme. Health Care Fin Rev. 2004;25(3):55-67. [Abstract | Full text]
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  6. Product Information: Botox. Gordon, NSW: Allergan Australia Pty Ltd; 24 March 2011.
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  11. About hyperhidrosis: The effect on patients’ lives: Quality-of-life surveys [online]. Quakertown, PA: International Hyperhidrosis Society; 2012 [cited 2 January 2012]. Available from: [URL link
  12. Benhanian A, Solish N. Hyperhidrosis: Sweating out the details. Can J CME. 2004;June:77-81. [Full text]
  13. Lowe NJ, Glaser DA, Eadie N, et al. 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):604-11. [Abstract]
  14. Walling H, Swick B. Treatment options for hyperhidrosis. Am J Clin Dermatol. 2011;12(5):285-95. [Abstract]
  15. Mahendiran S, Burkhart CN, Burlhart CG. Hyperhidrosis: A review of a medical condition. Open Dermatol J. 2009;3:195-7. [Full text]
  16. Cerfolio RJ, Milanez de Campos JR, Bryant AS, et al. The Society of Thoracic Surgeons expert consensus for the surgical treatment of hyperhidrosis. Ann Thorac Surg. 2011;91(5):1642-8. [Abstract | Full text]
  17. Doolabh N, Horswell S, Woilliams M, et al. Thoracoscopic sympathectomy for hyperhidrosis: Indications and results. Ann Thorac Surg. 2004;77(2):410-4. [Abstract]
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Dates

Posted On: 12 March, 2012
Modified On: 19 March, 2014

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