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Greater Manchester EUR Policy Statement on: GM Ref: GM016 Version: 3.2 (25 January 2019)

Commissioning Statement

Hyperhidrosis

Policy Treatment/procedures undertaken as part of an externally funded trial or as a part of Exclusions locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally (Alternative agreed pathways take precedent over this policy (the EUR Team should be informed commissioning of any local pathway for this exclusion to take effect). arrangements apply)

Policy Hyperhidrosis is a medical condition in which a person sweats excessively and Inclusion unpredictably. People with hyperhidrosis may sweat even when the is Criteria cool or when they are at rest.

Prior to Referral This policy applies to primary focal (idiopathic) hyperhidrosis and in some cases where the hyperhidrosis is secondary to an underlying cause, provided all steps have been taken to remove or ameliorate the cause and the hyperhidrosis persists: • Investigate and treat any underlying cause of the hyperhidrosis (see Appendix 2 for a list of potential underlying conditions). • Provide advice on lifestyle modifications made (see list in Appendix 2). • Advise the patient to use (via over the counter purchase) topical aluminium salt + 1% hydrocortisone cream, if necessary. • If topical treatments do not work after 1 month consider an oral (as advised by NICE ES10 Hyperhidrosis: oxybutynin1). • If facilities are available, consider tap water .

Referral Axillary Hyperhidrosis • Iontophoresis: the initial schedule of treatment is commissioned for delivery in secondary care - if successful the patient is expected to purchase their own machine for home usage. • If iontophoresis is not successful then the use of Botox, in line with GMMMG guidance, is commissioned. • Where available local surgical management may be considered where none of the above work (laser sweat ablation or retro dermal curettage).

Palmar / Planter Hyperhidrosis • Iontophoresis: the initial schedule of treatment is commissioned for delivery in secondary care - if successful the patient is expected to purchase their own machine for home usage. • If iontophoresis is not successful then consider the use of not tried in primary care. • In exceptional cases consider Botox, in line with GMMMG guidance (note the significant risk of complications associated with this).

1 immediate release (IR, off-label) should be prescribed in preference to (unlicensed) or (less effective). The level of evidence for oxybutynin IR and glycopyrronium bromide are of similar strength (weak) – please check relevant GMMMG guidance for up to date information.

GM Hyperhidrosis Policy v3.2 FINAL Page 2 of 17

Cranio – Facial Hyperhidrosis • Consider the use of anticholinergics not tried in primary care. • Consider Botox, in line with GMMMG guidance.

NOTE: Thoracic sympathectomy carries risks and is NOT commissioned due to weak evidence of success and the high risk of morbidity associated with the procedure.

Funding Mechanism Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria.

NOTE: Ensure the referral letter / form contains all the management options tried to date, with the outcome for each PLUS comments on all investigations undertaken to rule out an underlying cause for the hyperhidrosis.

If the patient does not meet the criteria: an individual funding request can be made if there is a good case for clinical exceptionality provided all conservative treatments have been exhausted. Requests must be submitted with all relevant supporting evidence.

Clinical Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if Exceptionality they feel there is a good case for exceptionality.

Exceptionality means ‘a person to which the general rule is not applicable’. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: • Significantly different to the general population of patients with the condition in question. and as a result of that difference • They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition.

Fitness for NOTE: All patients should be assessed as fit for surgery before going ahead with Surgery treatment, even though funding has been approved.

Best Practice All providers are expected to follow best practice guidelines (where available) in the Guidelines management of these conditions.

GM Hyperhidrosis Policy v3.2 FINAL Page 3 of 17 Contents

Commissioning Statement ...... 2 Policy Statement ...... 5 Equality & Equity Statement ...... 5 Governance Arrangements ...... 5 Aims and Objectives ...... 5 Rationale behind the policy statement ...... 6 Treatment / Procedure ...... 6 Epidemiology and Need ...... 6 Adherence to NICE Guidance ...... 6 Audit Requirements ...... 6 Date of Review ...... 6 Glossary ...... 7 References ...... 7 Governance Approvals ...... 7 Appendix 1 – Evidence Review ...... 8 Appendix 2 – Lifestyle factors and causes of secondary hyperhidrosis ...... 13 Appendix 3 – NICE Clinical Knowledge Summary – Hyperhidrosis ...... 14 Appendix 4 – Diagnostic and Procedure Codes ...... 15 Appendix 5 – Version History ...... 16

GM Hyperhidrosis Policy v3.2 FINAL Page 4 of 17 Policy Statement

Greater Manchester Health and Care Commissioning (GMHCC) Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document.

In creating this policy GMHCC/GM EUR Steering Group have reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources.

This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester.

This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement

GMHCC/CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. GMHCC/CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMHCC/CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation.

In developing policy the GMHCC EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group.

The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in GMHCC evidencing taking ‘due regard’ for fair access to healthcare information, services and premises.

An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements

Greater Manchester EUR policy statements will be ratified by the Greater Manchester Joint Commissioning Board (GMJCB) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives

This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: • reducing the variation in access to treatments/procedures.

GM Hyperhidrosis Policy v3.2 FINAL Page 5 of 17 • ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. • reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. • promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement

Hyperhidrosis can be a debilitating problem for those who suffer from it. In order to target resources at those who will gain the most benefit and to avoid harm these should be offered in order from less to more invasive as described in the Commissioning Statement.

Treatment / Procedure

This policy covers the secondary care aspects of the treatment of hyperhidrosis (a medical condition in which a person sweats excessively and unpredictably).

Hyperhidrosis is a medical condition in which a person sweats excessively and unpredictably. People with hyperhidrosis may sweat even when the temperature is cool or when they are at rest.

Epidemiology and Need

There is no data to indicate how common hyperhidrosis is in the UK, but it is reported to affect 3 in every 100 people in the USA [Hornberger et al, 2004].2

Those with hyperhidrosis appear to have overactive sweat glands. The uncontrollable sweating can lead to significant discomfort, both physical and emotional.

When excessive sweating affects the hands, feet, and armpits, it's called primary or . Primary hyperhidrosis affects 2-3% of the population, yet less than 40% of patients with this condition seek medical advice. In the majority of primary hyperhidrosis cases, no cause can be found. It seems to run in families.

If the sweating occurs as a result of another medical condition, it is called secondary hyperhidrosis. The sweating may be all over the body, or it may be in one area.

Adherence to NICE Guidance

This policy takes account of NICE IPG487: Endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb.

Audit Requirements

There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review

Five years from the date of the last review, unless new evidence or technology is available sooner.

The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All

2 NICE CKS - Hyperhidrosis

GM Hyperhidrosis Policy v3.2 FINAL Page 6 of 17 available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

Hyperhidrosis Excessive .

Iontophoresis A painless alternative to drug injection in which a weak electrical current is used to stimulate drug-carrying ions to pass through intact skin.

Sympathectomy Surgery that interrupts a nerve pathway of the sympathetic or involuntary nervous system.

References 1. GM EUR Operational Policy 2. NHS Bury Clinical Commissioning Group treatment pathway for Hyperhidrosis

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 17/09/2014

Greater Manchester Chief Finance Officers / Greater Manchester Directors of 20/10/2014 Commissioning

Greater Manchester Association Governing Group 04/11/2014

Bolton Clinical Commissioning Group 28/11/2014

Bury Clinical Commissioning Group 04/02/2015

Heywood, Middleton & Rochdale Clinical Commissioning Group 21/11/2014

Central Manchester Clinical Commissioning Group 15/01/2015

North Manchester Clinical Commissioning Group 12/11/2014

Oldham Clinical Commissioning Group 04/12/2014

Salford Clinical Commissioning Group 04/11/2014

South Manchester Clinical Commissioning Group 14/01/2015

Stockport Clinical Commissioning Group 03/12/2014

Tameside & Glossop Clinical Commissioning Group 05/11/2014

Trafford Clinical Commissioning Group 18/11/2014

Wigan Borough Clinical Commissioning Group 03/12/2014

GM Hyperhidrosis Policy v3.2 FINAL Page 7 of 17 Appendix 1 – Evidence Review Hyperhidrosis GM016

Search Strategy

The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below:

Database Result

NICE NICE IPG487: Endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb (Added at review: Nov 2015)

NICE ESUOM16: Hyperhidrosis: Oral Glycopyrronium Bromide

NICE ES10: Hyperhidrosis: oxybutynin (Published: 21 March 2017) – added at review: Nov 2017

NHS evidence Thoracoscopic sympathicotomy for disabling palmar hyperhidrosis: a prospective randomized comparison between two levels, Baumgartner FJ, Reyes M, Sarkisyan GG, Iglesias A, Reyes E., The Annals of thoracic surgery Dec 2011 Vol 92 Issue 6 pp2015-9 (also found on cohrane database)

NICE Clinical Knowledge Summary (CKS) – Hyperhidrosis (see also Appendix 3)

Cochrane Interventions for excessive sweating of unknown cause (Protocol not yet available for citation) - withdrawn study not done

BMJ Best Practice Not done since there is a NICE CKS

General Search (Google) Papers providing clinical opinion only (not referenced here)

The East of England Priorities Advisory Committee Guidelines: Management of Hyperhidrosis, March 2014

Medline / Open Athens Initial search of treatment for hyperhidrosis yielded no further results

Summary of the evidence

Available reviews suggest that accurate diagnosis will allow treatment of the underlying condition where this exists. For primary hyperhidrosis treatment is based predominantly on lower quality studies (case series etc.) and on consensus professional opinion.

Added at review Nov 2017: Updated evidence suggests that there should be discrete pathways for different types of hyperhidrosis and for the different areas affected. These pathways should be in line with the NICE assessment of oxybutynin and with the proposed GMMMG guidance on the use of .

GM Hyperhidrosis Policy v3.2 FINAL Page 8 of 17 The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL N/A: NICE EVIDENCE SUMMARY: UNLICENSED OR OFF-LABEL MEDICINE ESUOM16: Hyperhidrosis: Oral Glycopyrronium Bromide

Effectiveness: No randomised controlled trials were identified. Across a number of case series, involving around 150 adults, children and young people, hyperhidrosis 'responded' to oral glycopyrronium bromide tablets in 67–90% of participants. Safety: Contraindicated in medical conditions that preclude antimuscarinic therapy. Specific warnings about and heat stroke as a result of decreased sweating in high environmental , diarrhoea, which may be an early symptom of incomplete intestinal obstruction. Patient factors: Glycopyrronium bromide tablets and oral solution or suspension are imported or prepared by 'specials' manufacturers. Dosage varies, ranging from 1 mg to a maximum 8 mg (in divided doses) daily in case series. Across case series 29–79% of participants experienced adverse effects, most frequently dry mouth (affecting 16–63%). In 3 case series, 26%, 20% and 3% of participants withdrew because of adverse effects. In 2 case series, no withdrawals because of adverse effects were reported. Resource implications: The cost of glycopyrronium bromide tablets varies depending on the source and the dosage used. In 2012 in England there were 21,600 items dispensed for oral glycopyrronium bromide at a net cost of £5,732,400 (indications not known). Cost per item for tablets between £268.57 and £712.34 (number of tablets per item not known).

2. LEVEL 2: RANDOMIZED CONTROL TRIAL Thoracoscopic sympathicotomy for disabling palmar hyperhidrosis: a prospective randomized comparison between two levels, Baumgartner FJ, Reyes M, Sarkisyan GG, Iglesias A, Reyes E., The Annals of thoracic surgery Dec 2011 Vol 92 Issue 6 pp2015-9

Background: Thoracoscopic sympathicotomy is highly effective in treating disabling palmar hyperhidrosis. The ideal level to maximize efficacy and minimize the of compensatory hyperhidrosis (CH) is controversial. This study compared sympathicotomy over the second (R2) vs third (R3) costal head relative to these variables in patients with massive palmar hyperhidrosis. Methods: This prospective, randomized study enrolled 121 patients with disabling palmoplantar hyperhidrosis assigned to bilateral sympathicotomy (sympathetic transection), which was done over R2 in 61 (n = 122 extremities) or R3 in 60 (n = 120 extremities). Patients were questioned at 6 months and at 1 year or more to assess efficacy, side effects, and satisfaction with the procedure. Results: Sympathicotomy at R2 failed to cure palmar hyperhidrosis in 5 of 122 (4.1%) extremities, but only 2 (1.6%) were to a truly profound dripping level of recurrence. Sympathicotomy at R3 failed to cure palmar hyperhidrosis in 5 of 120 extremities (4.2%), and all were dramatic failures with dripping recurrent sweating. The patients whose palmar hyperhidrosis was not completely cured were aged 19.7 ± 2.5 vs 26.4 ± 8.0 years (p = 0.04). Two R3 patients with failure underwent three redo R2 sympathicotomies, with curative results. R2 patients showed a trend toward a higher level of CH vs R3 patients at 6 months and after 1 year. The CH severity scale was 4.7 ± 2.7 (n = 38) for R2 vs 3.8 ± 2.8 (n = 36) for R3 (p = NS) at 6 months and 4.7 ± 2.5 (n = 43) for R2 vs 3.7 ± 2.8 (n = 37) for R3 (p = NS) after 1 year. Younger

GM Hyperhidrosis Policy v3.2 FINAL Page 9 of 17 age, male sex, and higher levels of preoperative and postoperative plantar sweating were predictors of failed sympathicotomy. Increased age was associated with increased CH. Conclusions: R2 and R3 sympathicotomy for massive palmoplantar hyperhidrosis are highly effective, with low recurrence and incidences of severe CH. R2 tends to have a higher level of CH vs R3, and a higher incidence of dramatic failures is suggested in R3 patients, for which reoperation at the R2 level will likely be curative.

3. LEVEL 1 (SYSTEMATIC REVIEW) AND 5 (EXPERT OPINION) COMBINED NICE Clinical Knowledge Summary (CKS) – Hyperhidrosis (see also Appendix 3)

SUMMARY Hyperhidrosis, or excessive sweating, can be classified by location (focal or generalized) and by the presence of an underlying cause (primary or secondary): • Primary focal hyperhidrosis (sometimes known as primary idiopathic, primary localized, or simply 'focal' hyperhidrosis) may affect the axillae, hands, feet, face, or scalp, and has no underlying cause [Hornberger et al, 2004]. It typically begins during childhood or adolescence, but can occur at any age [Hornberger et al, 2004]. • Secondary focal hyperhidrosis involves specific areas of the body, but is caused by an underlying condition, such as a neuropathy, spinal disease or injury, or compensatory hyperhidrosis [Lowe et al, 2003]. • Generalized hyperhidrosis affects the entire skin surface area and is usually secondary to other medical conditions or induced by drugs [International Hyperhidrosis Society, 2008c]. If the presentation is characteristic, no laboratory tests are needed. Treatment should be reviewed after 1–2 months. If successful, it can be continued indefinitely. Referral to a dermatologist should be arranged if the above measures are inadequate or unacceptable. An underlying cause should be suspected if any of the following affect the person with hyperhidrosis: • Generalized sweating. • Sweating during sleep. • Symptoms and signs of systemic disease. • Prescribed drugs that are known to cause sweating. • Unilateral or asymmetric sweating (which suggest a neurological lesion or tumour, an intrathoracic malignancy, or a cervical rib). For people with suspected secondary focal or generalised hyperhidrosis, the history, examination, and investigations should look for an underlying cause. Appropriate management will often include a referral to secondary care. Management of primary focal hyperhidrosis • Provide advice about lifestyle measures and sources of information and support. • Recommend 20% aluminium chloride hexahydrate: o Advise the person to avoid shaving for 24 hours before and after application. o Consider soaking lotion pads for application to the face. o For plantar hyperhidrosis, an aluminium salt dusting powder (Zeasorb®) can be used as an alternative to 20% aluminium chloride hexahydrate solution or spray. o Advise that skin irritation may occur. This can be managed by: . The use of topical emollients and soap substitutes. . A reduction in the frequency of application. . Giving a short course of 1% hydrocortisone cream, for up to 2 weeks. o Review 1–2 months after starting treatment. If successful, it can be continued indefinitely. • Consider treating any underlying , which may be an exacerbating factor: o Cognitive behavioural therapy may be preferable to antidepressants or , which can cause or worsen hyperhidrosis.

GM Hyperhidrosis Policy v3.2 FINAL Page 10 of 17 • Refer to a dermatologist if the above measures are inadequate or unacceptable. Inform people about sources of information and support: • The Hyperhidrosis Support Group at www.hyperhidrosisuk.org • The International Hyperhidrosis Society at www.sweathelp.org Recommendations are based on expert opinion in the absence of trial evidence [Lowe et al, 2003; Hornberger et al, 2004; Clark, 2006; Halford, 2006]. Treatments in secondary care • Modified topical therapy: • Iontophoresis: • Botulinum toxin: • Surgery: o Resection of sweat glands o Endoscopic thoracic sympathectomy (ETS): • Other treatments that may be used: o Oral antimuscarinics, such as glycopyrronium bromide (which needs to be imported) and oxybutinin, may be used, but their use is limited by adverse effects. o Clonidine. o Diltiazem. o Benzodiazepines. Management of secondary focal or generalized hyperhidrosis • Direct the history, examination, and investigations to look for an underlying cause, and manage appropriately. This will often require a referral to secondary care. (see detail in appendix 2) Recommendations are based on expert opinion from Guidelines for the primary care treatment and referral of focal hyperhidrosis [Lowe et al, 2003] and a US expert consensus statement, Recognition, diagnosis, and treatment of primary hyperhidrosis [Hornberger et al, 2004].

4. LEVEL N/A: NICE INTERVENTIONAL PROCEDURE GUIDANCE NICE IPG 487: Endoscopic thoracic sympathectomy for primary hyperhidrosis of the upper limb

Summary of the guidance: 1.1 Current evidence on the efficacy and safety of endoscopic thoracic sympathectomy (ETS) for primary hyperhidrosis of the upper limb is adequate to support the use of this procedure with normal arrangements for clinical governance, consent and audit. 1.2 Clinicians wishing to undertake ETS for primary hyperhidrosis of the upper limb should ensure that patients understand the risks of the procedure. In particular they must explain that: • there is a risk of serious complications • hyperhidrosis elsewhere on the body is usual after the procedure: this can be severe and distressing and some patients regret having had the procedure (especially because of subsequent and persistent hyperhidrosis elsewhere) • the procedure sometimes does not reduce upper limb hyperhidrosis. Clinicians should also provide patients considering the procedure with clear written information. 1.3 In view of the risk of side effects this procedure should only be considered in patients suffering from severe and debilitating primary hyperhidrosis that has been refractory to other treatments. 1.4 This procedure should only be undertaken by clinicians trained and experienced in thoracic endoscopy, and there should be the capacity to deal with intraoperative complications. 1.5 Further research into ETS for primary hyperhidrosis of the upper limb should include clear information on patient selection and should seek to identify which patient characteristics might predict severe side effects. All complications should be reported. Outcomes should include

GM Hyperhidrosis Policy v3.2 FINAL Page 11 of 17 measurements of efficacy, including quality of life and social functioning both in the short and long term and in particular the frequency and severity of compensatory hyperhidrosis.

5. LEVEL 1: MEDS OPTIMISATION REVIEW AND GUIDELINES (EAST OF ENGLAND) The East of England Priorities Advisory Committee Guidelines: Management of Hyperhidrosis, March 2014

Patients with localised (focal) hyperhidrosis should initially be treated in primary care. • Patient with localized hyperhidrosis Disease Severity Scale (HDSS) score or 3 or 4 who do not respond to initial treatment in primary care should be referred to secondary care (see treatment pathway). • Patients with generalised hyperhidrosis should be referred to secondary care. • Oxybutynin immediate release (IR, off-label) should be prescribed in preference to glycopyrronium bromide (unlicensed) or propantheline bromide (less effective). The level of evidence for oxybutynin IR and glycopyrronium bromide are of similar strength (weak). • Endoscopic Thoracic Sympathectomy (ETS) should no longer be offered due to weak evidence and a significant risk of morbidity. • Tap-water iontophoresis is non-invasive and should be offered for palmar, plantar and axillary hyperhidrosis. Axillary iontophoresis may be effective in practice despite lack of published evidence (expert opinion). Costs should be limited to activity costs for the initial treatment schedule. • Iontophoresis with glycopyrronium bromide is not recommended as the level of evidence for adding glycopyrronium bromide solution is weak and costs in primary care are prohibitive. It is not appropriate for ongoing prescriptions to originate from secondary care as patients could be discharged from the service after a successful trial of iontophoresis. • Ablation surgery of the axillae should be offered as an alternative to botulinum toxin A in specialised centres

6. LEVEL 1: NICE EVIDENCE SUMMARY NICE Evidence Summary: ES10: Hyperhidrosis: oxybutynin (Published: 21 March 2017)

Likely place in therapy Local decision makers need to take safety, efficacy, cost and patient factors into account when considering the likely place in therapy of oxybutynin for hyperhidrosis. The studies found that oxybutynin (at a dosage of 2.5 mg to 10 mg daily) improved symptoms of hyperhidrosis and quality of life significantly more than placebo. The medicine appeared to be well tolerated, although dry mouth was frequently reported. The standard release formulation of oxybutynin, which was used in the studies, is inexpensive. Many people may prefer a topical treatment to risking the adverse effects of an oral treatment. However, an oral treatment may be preferable to some other options, such as surgery. The clinical knowledge summary on hyperhidrosis suggests systemic therapies, including oral antimuscarinics, as treatment options for people whose hyperhidrosis is not adequately managed through lifestyle modifications and antiperspirants. Other treatments that may be considered include topical therapies (including topical glycopyrronium), iontophoresis, botulinum toxin injections, other systemic therapies (including clonidine, diltiazem, benzodiazepines) and surgery. Adverse events are common with oxybutynin, with dry mouth the most frequently reported, occurring in up to 100% of participants taking oxybutynin in the studies discussed in this evidence summary. Other common adverse events include dizziness, nausea, constipation and urinary retention. Treatment with oxybutynin may be limited by a person's ability to tolerate these side effects, although anticholinergic effects are often dose-dependent and may be minimised by using the lowest effective dose. Many of the participants involved in the studies discussed in this evidence summary had localised hyperhidrosis, which may be more appropriately managed using local treatments including antiperspirants and iontophoresis.

GM Hyperhidrosis Policy v3.2 FINAL Page 12 of 17 Appendix 2 – Lifestyle factors and causes of secondary hyperhidrosis

Lifestyle Factor Modifications: • Primary focal hyperhidrosis: Modify behaviour to avoid identified triggers (such as crowded rooms, , or spicy ), where possible. • Primary axillary hyperhidrosis: Use a commercial antiperspirant (as opposed to a ) frequently. Avoid tight clothing and manmade fabrics. Wear white (as opposed to blue) shirts or black clothing to minimize the signs of sweating. Consider using dress shields (also known as armpit or sweat shields) to absorb excess sweat and protect delicate or expensive clothing. These can be obtained via the internet or the Hyperhidrosis Support Group. • Primary plantar hyperhidrosis: Wear moisture-wicking socks, changing them at least twice daily. Use absorbent soles, and use absorbent foot powder twice daily. Avoid occlusive footwear such as boots or sports shoes; wear leather shoes. Alternate pairs of shoes on a daily basis to allow them to dry out fully before wearing them again • Primary craniofacial hyperhidrosis: Avoid and drink triggers where possible, if they exacerbate symptoms (including caffeinated products, chocolate, spicy or sour foods, hot foods, alcohol, foods or drinks containing citric acid, or sweets).

Conditions that cause secondary hyperhidrosis include: • • Anxiety conditions • • syndrome • Certain medications and substances of abuse • Glucose control disorders • Heart disease • Hyperthyroidism • Lung disease • • Parkinson’s disease • • Spinal cord injury • Stroke • Tuberculosis or other

GM Hyperhidrosis Policy v3.2 FINAL Page 13 of 17 Appendix 3 – NICE Clinical Knowledge Summary – Hyperhidrosis Hyperhidrosis GM016

NICE Clinical Knowledge Summary (CKS) – Hyperhidrosis (click link to view: Appendix 3)

GM Hyperhidrosis Policy v3.2 FINAL Page 14 of 17 Appendix 4 – Diagnostic and Procedure Codes Hyperhidrosis GM016

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM016 - Hyperhidrosis Policy

Excision of thoracic sympathetic nerve A75.2

Chemical destruction of thoracic sympathetic nerve A76.2

Radiofrequency controlled thermal destruction of thoracic sympathetic nerve A78.2

Cryotherapy to thoracic sympathetic nerve A77.2

Destruction of thoracic sympathetic nerve NEC A79.2

Injection of therapeutic substance into skin; with X85.1 and Z49.2 as listed below S53.2

Torsion dystonias and other involuntary movements drugs Band 1 X85.1

Skin of axilla Z49.2

Excision of bearing skin axilla S04.1

With the following ICD-10 diagnosis code(s):

Localized hyperhidrosis R61.0

Generalized hyperhidrosis R61.1

Hyperhidrosis, unspecified R61.9

GM Hyperhidrosis Policy v3.2 FINAL Page 15 of 17 Appendix 5 – Version History Hyperhidrosis GM016

The latest version of this policy can be found here: GM Hyperhidrosis policy

Version Date Summary of Changes

0.1 12/11/2013 Initial draft

0.2 17/02/2014 • Under section 3, aims and objectives, the word 'routinely' taken out of first sentence. • 'Mandatory Criteria' section amended. • Last sentence under 'Description of Epidemiology and Need' shortened. • Reference number 3 under 'The evidence' amended. • Appendix 2 and 3 added.

0.3 27/03/2014 Amendments made by GM EUR Steering Group on 19/03/2014: • Removal of Appendix 3 – NICE CKS – added as an embedded document in the search strategy table in Appendix 1. • Definition of hyperhidrosis included in the mandatory criteria section. 19/03/2014 Draft policy approved by GM EUR Steering Group subject to the above amendments

0.4 09/04/2014 • Statement regarding treating disabled people as more equal than other protected characteristic groups added to Equality and Equity section. • Ratification through CCG Governing Bodies added to ‘Governance Arrangements’. • Rationale for policy development included.

0.5 23/07/2014 Amendments made by the GM EUR Steering Group on 09/07/2014: • Revision of Section 4, 3rd paragraph – removal of 'proof will also be required to show’ and replaced with ‘the referral letter should indicate' • Paragraph under the bullet points amended: ‘considered’ changed to ‘offered’ and ‘exceptional’ changed to ‘significant and’ • Bullet points removed from section 7 and the preceding paragraph adjusted to reflect this. The words ‘to avoid harm’ also included in preceding paragraph after ‘benefit’ and before ‘these’. Final paragraph under section 7 moved to section 4. • Funding mechanism has been amended to monitored approval.

0.6 29/08/2014 Amendments made to section 4 to include treatment specific to the different anatomical areas following comments/discussion with Dr Fitzgerald, consultant dermatologist, Salford Royal Foundation Trust.

0.7 03/10/2014 Branding change following creation of North West CSU on 01/10/2014

1.0 17/09/2014 Policy approved for governance by Greater Manchester EUR Steering Group.

2.0 18/11/2015 Annual review of policy by GM EUR Steering Group – no material changes necessary to the current policy: • Added that locally commissioned treatment as part of a pathway of care within a contract or service level and treatment as part of previously agreed and externally funding trial are excluded from this policy. • Evidence Review section updated

GM Hyperhidrosis Policy v3.2 FINAL Page 16 of 17 2.1 05/04/2016 • List of diagnostic and procedure codes in relation to this policy added as Appendix 4. • Page for Appendix 3 link to NICE CKS added. • Policy changed to GMSS template and references to NWCSU changed to GMSS. • Wording for date of review amended to read “One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years)” on ‘Policy Statement’ and section ‘13. Date of Review’.

3.0 15/11/2017 Review of policy by GM EUR Steering Group: & • Policy moved to new format 17/01/2017 Policy Inclusion Criteria: • Criteria re-written and divided up into sections for 'Prior to Referral' and 'Referral' and subheadings for ‘Axillary Hyperhidrosis’, ‘Palmer / Planter Hyperhidrosis’ and ‘Cranio - Facial Hyperhidrosis’ • Note added to end of ‘Referral’ section about thoracic sympathectomy • Note added to funding mechanism around management options tried to date, outcome and comments on all investigations undertaken to rule out underlying cause • Date of Review: Standard wording on next review amended to state ‘5 years’ • Appendix 1 - Evidence Review: Section updated The above changes were not considered to be material and therefore it was not necessary for the revised policy to go back through the governance process again.

3.1 06/06/2018 Appendix 2: Added OPCS-4 code S04.1 Excision of sweat gland bearing skin axilla

3.2 25/01/2019 • Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning. • Links updated as documents have all moved to a new EUR web address. • Commissioning Statement: o ‘(Alternative commissioning arrangements apply)’ added after Policy Exclusions o ‘Fitness for Surgery’ section added o ‘Best Practice Guideline’ section added

GM Hyperhidrosis Policy v3.2 FINAL Page 17 of 17