BOTULINUM TOXIN POLICY TO INCLUDE:

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1 BOTULINUM TOXIN POLICY TO INCLUDE: Blepharospasm in adults, Hemi facial spasm in adults, spasmodic torticollis (cervical dystonia), focal spasticity treatment of dynamic equinus foot deformity, focal spasticity treatment in paediatric cerebral palsy, focal spasticity in adults (upper limb due to stroke or non-stroke neurological disease), prophylaxis of headaches in adults with chronic migraine, severe hyperhidrosis of the axillae, gastroparesis, anal fissure & bladder dysfunction in adults. Commissioning Policy Introduction Botulinum Toxin A is a powerful neurotoxin which is used medically to relax muscles and for certain conditions there are recognised benefits to patients. This document summarises the commissioning status of Botulinum Toxin A for specific medical conditions. Botulinum Toxin treatment will not be available for the treatment of facial ageing or excessive wrinkles. NICE clinical guidelines are recommendations by NICE on the appropriate treatment and care of people with specific diseases and conditions within the NHS. They are based on best available evidence. NHS organisations are entitled to take decisions which do not follow Guidance (other than NICE TAs) if they have a good reason to do so. The availability of resources and competing priorities can be a good reason. Indication Commissioning Status Criteria (Conditions)/Notes Blepharospasm in adults (facial dystonia, muscles around the eyes can cause uncontrolled blinking, lid spasm. Prior Approval with evidence of functional or visual impairment. Funding will not be approved for treatment periods less than 4 monthly. Hemi facial spasm in adults (movement disorder causing muscles on the side of the face to contract uncontrollably). Prior Approval with evidence of functional or visual impairment. Funding will not be approved for treatment periods less than 4 monthly. Spasmodic torticollis (cervical dystonia) (muscles in the neck contract involuntarily) Indication routinely funded Criteria Based Access

2 Focal Spasticity treatment of dynamic equinus foot deformity due to spasticity in paediatric cerebral palsy patients Indication routinely funded Focal Spasticity treatment in paediatric cerebral palsy upper limb (as per NICE CG 145) Indication routinely funded Focal Spasticity in adults (upper limb due to stroke or non-stroke neurological disease) Prior Approval See Appendix 1 Patient is 18 years. The spasticity has a significant component of focal or multi-focal dynamic spastic muscle component not contracture. More than one injection will not be routinely commissioned. Clinicians are asked to submit a request with rationale for on-going injections and evidence of benefit from previous injection. Prophylaxis of headaches in adults with chronic migraine (in line with NICE TA 260) Prior Approval See Appendix 2 May be considered as a treatment option in line with NICE TA 260. To be read in conjunction with summary sheet and flow chart in appendix 2 Initiation criteria Headaches on at least 15 days per month of which at least 8 are with migraine. Provide a record of prior pharmacological headache prophylaxis therapies. To include drug name, dose &frequency. Start date, stop date & reason for discontinuation. Medication overuse headache has been ruled out. Other causative disorders have been ruled out. Patient keeps a headache diary. Retreatment Criteria For eligible patients funding approvals will be given for a first and follow up injection (i.e. two injections) on each occasion. First response assessment to be made following 2nd injection. Percentage reduction in headache days per month after initial 2 treatment cycles, measured over a period of at least a month.

3 Number of headache days/month measured over 3 consecutive months Severe hyperhidrosis of the axillae Not routinely commissioned Gastroparesis Not routinely commissioned Anal fissure Criteria Based Access for first treatment Prior Approval for any subsequent treatment See appendix 3 for management criteria NICE Evidence summary unlicensed off label Medicine 14: Chronic anal fissure: Botulinum toxin-type A injection. Evidence from 2 systematic review and 4 further randomised controlled trials suggests that the botulinum toxin type A injection is less effective than surgery, no better or worse than topical glyceryl trinitrate (GTN: 0.2% ointment) on isosorbide dinitrate and no better than placebo or lidocaine at healing anal fissure.

4 Management of bladder dysfunction in adults not adequately managed with anticholinergics for: Over-active bladder with symptoms of urinary incontinence, urgency and frequency. Neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury or MS Prior Approval See Appendix 4 May be considered as a treatment option in patients who fulfil the following eligibility and continuation criteria: 1. Received and not responded to a trial of conservative management. Lifestyle interventions including: o Modify high or low fluid intake. o Reduce weight. o Reduce caffeine. Appropriate behavioural management programme (e.g. bladder training lasting at least 6 weeks). For patients with mixed urinary incontinence pelvic floor muscle training lasting at least 3 months. 2. Received and not responded to drug trials of (unless contra-indicated or not tolerated): At least 3 anti-muscarinic drugs tried for 2 months each. In post-menopausal women with vaginal atrophy intra-vaginal oestrogen for 3 months. 3. Urodynamic confirmed detrusor over activity. 4. Symptom severity should be reviewed (from a patient completed bladder diary of at least 3 days) by a consultant urologist to determine clinical suitability for treatment and to ensure the eligibility criteria are met. 5. Willing and able to self-catheterise. 6. Continuation criteria assessed at 3 months following treatment of: A 50% or greater improvement in continence episodes or urgency episodes per day. 7. Repeat injections to be given no less than 9 months following previous injection. Requesting specialists to complete the relevant retreatment request via Prior Approvals. See appendix 4.

5 Botulinum toxin products: rare but serious risk Appendix 1 MHRA Drug safety Update Products that contain botulinum toxin are associated with the risk of serious adverse reactions due to distant spread of toxin. Recommendations include: Only physicians with appropriate experience (including use of the required equipment) should administer products that contain botulinum toxin. Patients or caregivers should be informed about the risk of spread of toxin, and should be advised to seek immediate medical care if problems with swallowing or speech develop, or if respiratory symptoms arise. Units of botulinum toxin are not interchangeable from one product to another. Recommended administration techniques and specific dosing guidance (including the recommendation to use minimum effective dose and titrate according to individual need) should be followed. References MHRA Drug safety Update October 2007; Vol 1, Issue 3: 10http:// note licence indications for individual products for specific Appendix 2a Prophylaxis of headaches in adults with chronic migraine (NICE TA 260, June 2012) NICE Recommendation: 1.1 Botulinum toxin type A is recommended as an option for the prophylaxis of headaches in adults with chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine): That has not responded to at least three prior pharmacological prophylaxis therapies AND Whose condition is appropriately managed for medication over-use. 1.2 Treatment with botulinum toxin type A that is recommended according to 1.1 should be stopped in people whose condition: Is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles) or Has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months.

6 Appendix 2b Chronic Migraine Pathway for adults Primary Care diagnosis of chronic migraine Diagnosis based on history & normal physical examination Ensure no medication overuse* (see notes overleaf & references for further info) >15 headache days/ month, of which 8 migrainous. Encourage patient to keep headache diary* (see notes) Lifestyle changes including avoidance of trigger factors Prophylactic medication (3 options must be tried before referral for Botox): Primary care treatment of chronic migraine 1. Amitriptyline 10-70mg nocte. (N.B. Not included in NICE CG150, but local neurologists recommend this option first-line) Useful if migraine co-exists with depression, disturbed sleep, chronic pain condition or troublesome tension-type headache. 2. Propranolol LA 80 mg od -160mg bd or atenolol 25mg od increasing to 50mg od (both unlicensed, atenolol may be better tolerated but not included in NICE CG150). 3. Topiramate* Licensed dose: Initially 25mg ON for 1/52 then increase by 25mg/wk; usual dose mg daily in 2 divided doses; max 200mg od. Local consultants advise to start at low doses (e.g. 15mg od) & titrate slowly (due to side effects being common) to maintenance of 50mg bd. 4.) Gabapentin up to 1200mg/day recommended by NICE, however local consultants use up to 1800mg/day (in div. doses). Start at 100mg tds, increasing by 100mg tds weekly (unlicensed). Trial at maximum tolerated dose for 6-8 weeks. Review the need for continuing migraine prophylaxis 6 months after the start of prophylactic treatment if effective. Acute medication: Triptans (see formulary) up to 6 days/month; NSAID up to 10 days/month. Accupuncture is recommended by NICE and our local commissioners are working on development of a service for this group of patients Patient referred to Consultant Neurologist. GP refers patient with difficult to treat headache or where diagnosis is uncertain for 2nd opinion. Most patients will be referred back to GP after one consultation. The consultant will consider one of the following options with the patient. Prophylactic medications Consider: Methysergide 1mg-6mg (licensed) or valproate N.B. Both not rec. by NICE CG150 but are in the BASH guidelines- see references. Consider combination prophylactic therapy if individual treatments ineffective. Greater Occipital Nerve block (GON) If effective, may be repeated 3 monthly Botox Injection. Botox 155U-195U (licensed), consider if failure to respond to at least 3 prophylactic medications and medication overuse excluded. If effective, repeat 12 weekly.. If ineffective, discontinue after 2 cycles of treatment.. Discontinue if reverts to episodic Consider pain clinic referral

7 Appendix 3 Management of anal fissures in adults Patients under 18 years of age must be referred to secondary care and are not covered by this pathway. Preliminary symptom assessment Typical anal fissure Patient presents with new onset fresh, bright-red rectal bleeding with pain Anal fissure usually has a posterior or anterior location No evidence of Crohn s disease First line treatment-trial for 6-8 weeks Bulk fibre supplements (advise to drink plenty of water) +/- stool softeners Consider adding in glyceryl trinitrate 0.4% ointment bd. (Warn patient of risk of headaches.) Consider adding a local anaesthetic treatment Second line treatment GP to prescribe one course of diltiazem 2% cream (unlicensed) Do not prescribe diltiazem 2% ointment as it is more expensive that the cream Apply TWICE daily EVERY DAY for 2 months One course is two 30g tubes which should last 2 months GP to supply patient information leaflet with the prescription It is crucial that the cream is applied twice daily every day to offer the best chance of successful healing GP to review patient in 6-8 weeks If healed no further treatment If no improvement after the first course of diltiazem 2% cream refer to the colorectal team If improving but not fully healed repeat the course of diltiazem 2% cream once only (2 x 30g), and if still not healed refer to colorectal team. Maximum of 4 x 30g diltiazem 2% cream to be prescribed in total If second line treatment unsuccessful refer to secondary care-colorectal team A single treatment of Botulinum toxin A will be funded for the treatment of chronic or recurrent anal fissures in adults where all other appropriate non-surgical pharmacological and dietary treatments, as stated above, have been tried and failed.

8 Appendix 4 Management of bladder dysfunction in adults not adequately managed with anticholinergics for: Overactive bladder with symptoms of urinary incontinence, urgency and frequency. Neurogenic detrusor over-activity with urinary incontinence due to sub-cervical spinal cord injury or MS.NICE CG 171 Urinary incontinence: The management of urinary incontinence in women. September 2013 NICE CG 148 Urinary incontinence in neurological disease: Management of lower urinary tract dysfunction in neurological disease. August 2012 NICE CG 97 Lower urinary tract symptoms: The management of lower urinary tract symptoms in men. May 2010.