Review for NHS Surrey Prescribing Clinical Network. Treatment: Botox for chronic migraine. Prepared by: Victoria Overland

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1 Review for NHS Surrey Prescribing Clinical Network Treatment: Botox for chronic migraine Prepared by: Victoria Overland Date: To be considered at September 2012 PCN meeting 1. Purpose of the Review NICE Technology Appraisal 260 Botulinum toxin type A for the prevention of headaches in adults with chronic migraine was published in June 2012 (full guidance embedded below): Guidance 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 overuse. 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. 1.3 People currently receiving botulinum toxin type A that is not recommended according to 1.1 and 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop. NICE TA260 Botox in Chronic Migraine.pdf Note Allergan s Botox product is currently the only botulinum toxin licensed for use in chronic migraine, botulinum toxins are not interchangeable for this indication. 2.3 The Intervention: The recommended reconstituted Botox dose is units, administered intramuscularly as 0.1 ml (5 units) injections to between 31 and 39 sites around the head and back of the neck. The recommended re-treatment schedule is every 12 weeks. Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan units are different from other botulinum toxin preparations. Care setting: Currently secondary care the following are proposed: SASH administration by consultant neurologist within existing botulinum toxin clinic ASPH administration by consultant neurologist or pain team in existing clinic after assessment for suitability & referral by a consultant neurologist

2 FPH administration by consultant neurologist or pain team in existing clinic after assessment for suitability & referral by a consultant neurologist - see draft treatment pathway attached Appendix 1. FPH propose using the Migraine Trust Diary to assess the number of headache days see Appendix 2 -cover letter with instructions for potential patients. RSCH administration by consultant neurologist/specialist nurse in existing clinic after assessment for suitability & referral by a consultant neurologist see draft treatment pathway attached - Appendix 3. ESHUT not currently proposing to use Botox for chronic migraine. Frequency: Every 12 weeks up to a maximum of 2 years. 2.4 Alternative treatments 1-6 : At present, there are no medicines specifically licensed for the prophylaxis of headache in chronic migraine patients. Prior to consideration for BOTOX patients should have received at least 3 of the following medications in primary and secondary care as prophylactic agents (licensed and unlicensed) against chronic migraine: Where possible discontinuation for side effects should mean a further oral agent is tried Beta-blockers (without partial agonism) Propranolol LA mg od Tricyclic Antidepressants (unlicensed use) Amitriptyline Antiepileptic agents Topiramate 25mg od-50mg bd under specialist supervision Sodium valproate mg bd (currently unlicensed) Pregabalin mg.d (currently unlicenced) Other agents Pizotifen mg od Methysergide 1-2mg tds Flunarizine (unlicenced in UK) 5-10mg daily] Verapamil MR mg bd (currently unlicensed) Aspirin 75mg od Candesartan 2mg od (unlicensed) INTERVENTIONAL MANAGEMENT STRATEGIES 6 Greater occipital nerve (GON) blocks or surgical implantation of occipital nerve or deep brain stimulators may be utilised, in some subjects if other treatments have been unsuccessful. Procedures of this kind are invasive and expensive. Clinical experience with GON blocks appears favourable to the patient and may provide relief for approximately one month, however little evidence exists for the efficacy this strategy in chronic migraine treatment.

3 3. Effectiveness 3.1 Expected benefits - Reduction in acute medication use - Reduction in number of migraines/migraine intensity -Objective improvement in quality of life 3.4 Evidence supporting its use NICE has reviewed the supporting evidence and concluded that the use of Botox for chronic migraine is a cost-effective treatment option. A positive technology appraisal has been issued (see NICE TA260 embedded above). 4. Summary of Key Points for Consideration 4.1 National guidance: Positive NICE TA Potential Benefits over existing therapy Less expensive than occipital nerve stimulator (cost approx ) or greater occipital nerve block (which is also unlicensed cost approx. 70 plus procedure cost of ). 4.4 Potential disadvantages Potential for high cost if patient numbers increase. 4.5 Budgetary Impact Cost: Vial price via South East tendering process (commercially confidential) As the recommended dose is 155 units 195 units, the 200 unit vial is most likely to be used (drug cost incl VAT). (NHS list price: 200 unit vial incl. VAT) NICE guidance states that the manufacturer estimates that the administration cost is 73 per treatment, based on a total treatment time of less than 30 minutes. Total cost per dose per patient approximately 340 Estimated patient numbers: Neurologists within Surrey have been consulted re. potential patient numbers: SASH estimated 10 patients FPH estimated 35 patients RSCH estimated patients (1 to 2 per month) ASPH estimated 20 patients ESHUT do not currently plan to use Botox TOTAL estimated up to 90 per year

4 50% of patients stop treatment after the initial 2 cycles. Of the 50% who continue and respond (but remain in chronic migraine and therefore still need treatment) 70% continued for up to 2 years. Estimated yearly cost to NHS Surrey (drug & administration) for the 50% stopping after 2 cycles for the 50% who continue (4 x 12 weekly cycles per year) TOTAL Precedent setting: All other PCTs within SEC SHA will be required to implement NICE TA260 within 90 days of its release. 5. Conclusions and Recommendations NHS Surrey has a statutory requirement to implement positive NICE technology appraisals. Suggested criteria/tick box form for funding notification: See Appendix References 1. Ashkenazi A, Levin M. Greater occipital nerve block for migraine and other headaches: is it useful? Curr Pain Headache Rep British Association for the Study of Headache "Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache" Jan Scottish Intercollegiate Guidelines Network National Clinical Guideline 107 "Diagnosis and Management of Headache in Adults" 4. Steiner and Martelletti. Collaborative guidance from the World Health Organisation and European Headache Foundation. Aids for management of common headache disorders in primary care. J Headache Pain S2 5. Silberstein S, for the US Headache Consortium. Practice parameter: Evidencebased guidelines for migraine headache (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000;55: Dr J. Kimber/Omar Ali. SASH DTC application Botox for chronic migraine.

5 Appendix1. FPH pathway No 2 Pathway for the use of Botulinum toxin type A (BOTOX ) for the prevention of headaches in adults with chronic migraine by Neurology and Chronic Pain Services. Originator Mrs Karin Cannons Nurse Consultant Pain Management Dr John O Dwyer Consultant Neurologist Dr Kevin Markham Lead Clinican Chronic Pain Service Dr Damian Wren Consultant Neurologist Lead Director Version number Version implementation date Ratified at Mr EdwardPalfrey Medical Director 2 draft July 2012 Pain MDT: Neurology MDT: Drugs and Therapeutics Review date

6 Chronic Migraine Pathway Patient referred to Consultant Neurologist GP/other physicians refer patients they think would benefit from Botox for chronic migraine Assessment of headache Dr O Dwyer or colleague sends the patient a headache diary and arranges to see them in clinic in a headache slot. Patient assessed in clinic, including Migraine Disability Assessment (MIDAS). Headache diary reviewed More than 15 headache days a month, of which 8 are migrainous 3 oral prophylactic medications have failed Medication overuse has been addressed Meets criteria for BOTOX 2 Treatment 1 given At end of assessment appointment Does not meet criteria Patient discharged back to GP or referring physician Treatment to be administered by Neurologist in outpatient clinic Patient completes headache diary for 3 months Headache Impact Test score (HITs) self test at 6 weeks If effective, the recommended re-treatment schedule is at 3 months. If ineffective (defined by NICE 1 as less than a 30% reduction in headache days per month), Botox will be discontinued after 2 cycles of treatment. If pattern has changed to episodic migraine (fewer than 15 headache days per month for 3 consecutive months) treatment will cease. If after 3 rd treatment ongoing treatment is required this will be provided either by Neurology or referral to Pain Clinic for ongoing therapy may be made BOTOX declined by patient or ineffective Consider Greater Occipital Nerve block performed either in outpatients department or minor operations suite by Neurologist or Pain Clinician Consider referral for CBT based Pain Management Programme via Pain Clinic If all treatments ineffective: Consider referral to a tertiary centre for consideration of Occipital Nerve Stimulation

7 Expected uptake of service Estimate for neurology is that they see around 100 patients per quarter with chronic migraine. The projected forecast is that 15 per quarter would meet the criteria of having tried 3 oral prophylactic medications thoroughly and have had their medication overuse issues addressed. 5 would then progress to BOTOX i.e. 20 to 25 patients per year from Neurology. The Chronic Pain Service received 10 enquires from patients or GPs in the last year about BOTOX for migraine prophylaxis. The service received 6 referrals from neurologists for biopsychosocial assessment and consideration of greater occipital nerve blocks and or pain management programme. Chronic Pain Service estimate is 5 to 10 patients per year for BOTOX for chronic migraine. BOTOX for migraine is not currently offered in pain clinics at Reading, Basingstoke, Winchester, Ashford and St Peters or the Royal Surrey. Dr Markham offers the procedure privately at Clare Park and the Parkside suite. With its high quality and strong Neurology and Chronic Pain Service, Frimley Park Hospital is well placed to offer this service to adult patients with chronic headache from across the region. Total estimated numbers at this stage 30 to 35 patients per year. References 1. NICE (2012) Botulinum toxin type A for the prevention of headaches in adults with chronic migraine. NICE technology appraisal guidance 260. Available at 2. Botox Summary of Product Characteristics Appendix : Dosing schedule The recommended reconstituted BOTOX dose for treating chronic migraine is 155 U to 195 U administered intramuscularly (IM) using a 30-gauge, 0.5 inch needle as 0.1 ml (5 U) injections to 31 and up to 39 sites. Injections should be divided across 7 specific head/neck muscle areas as specified in the diagrams below. A 1- inch needle may be needed in the neck region for patients with extremely thick neck muscles. With the exception of the procerus muscle, which should be injected at 1 site (midline), all muscles should be injected bilaterally with half the number of injections sites administered to the left, and half to the right side of the head and neck. If there is a predominant pain location(s), additional injections to one or both sides may be administered in up to 3 specific muscle groups (occipitalis, temporalis, and trapezius), up to the maximum dose per muscle as indicated in the table below. The following diagrams indicate the injection sites:

8 BOTOX Dosing By Muscle: Recommended Dose Head/Neck Area Total Dosage (number of sites a ) Frontalis b Corrugator b Procerus Occipitalis b Temporalis b Trapezius b Cervical Paraspinal Muscle Group b Total Dose Range: 20 U (4 sites) 10 U (2 sites) 5 U (1 site) 30 U (6 sites) up to 40 U (up to 8 sites) 40 U (8 sites) up to 50 U (up to 10 sites) 30 U (6 sites) up to 50 U (up to 10 sites) 20 U (4 sites) 155 U to 195 U 31 to 39 sites a 1 IM injection site = 0.1 ml = 5 U BOTOX b Dose distributed bilaterally The recommended re-treatment schedule is every 12 weeks.

9 Appendix 2: Frimley Park Hospital cover letter for potential patients Dear Sir/Madam, You will be attending a clinic appointment to determine your suitability for botulinum toxin (Botox) injection treatment for chronic migraine. You are being sent this appointment because we have been informed this treatment option has been discussed with you and you have agreed to be referred. On the day we will assess what preventative treatments you have already taken and their effect, including what ones you are currently on (if any). These are drugs that you will have taken every day to try reduce the frequency, severity and duration of migraine headaches. You will also be assessed as to the pattern and nature of your headaches over the three months consecutively and accurately recorded. There are FOUR things that you need to do: Fill in the attached headache diary covering a three month period: YOU MUST BRING ALL THESE TO YOUR APPOINTMENT failure to bring it will mean that treatment (if eligible) cannot be given Complete and return the HITS-6 questionnaire (enclosed) to this department Complete and return the Migraine Disability Assessment Test (enclosed) Make out a list of preventative medications that have been tried, to what dose they were built up to, the effect and for how long they were tried for: return this with the HITS and MIDAS (See next page for list of commonly used preventatives) If you are injected with On a botulinum toxin (Botox), you will be re injected after 3 months. You will need to continue to keep the headache diary paper record and bring to the next appointment(s) for re-evaluation. You will also need to complete the HITS-6 and Migraine Disability Assessment Test after 6 weeks and bring them with the headache diaries to your next appointments. If you do not keep the diaries, you will not be eligible to receive treatment with Botox for chronic migraine. Thank you for complying with the above, and we look forward to seeing you. Yours sincerely, John Philip O Dwyer MA MD MRCPI Consultant Neurologist Enclosed 1) HIT-6 questionnaire 2) Migraine Disability Assessment Test (MIDAS) 3) Three months of Migraine Diary from

10 Migraine Trust Headache Diary.pdf HIT 6 - Headache Quality of Life Score.pdf Migraine Disability Assessment Test.pdf (Max Dose daily / Duration of use / Effect / Not tolerated) Beta-Blockers Propranolol Atenolol Antidepressants Amitriptylline Nortriptylline Sertraline Fluoxetine Dothiepin Antiepileptics Valproate Gabapentin Topiramate Serotonin Agonists Methysergide Antiseretonergic/antihistamine Pizotifen Cyproheptadine Calcium Channel Blockers Flunarizine Amlodipine Verapamil

11 Appendix 3 RSCH chronic migraine treatment pathway

12 Appendix 4: DRAFT 2012/2013 PBR Exclusions Notification Funding Application for Botulinum Toxin A (Botox ) last updated:09/2012) Patient NHS No. Trust: GP Name: Patient Hospital No: Patient initials & DoB: Consultant Making Request: GP code / Practice code: Confirm patient status: (*select 1 option) NHS/Private/Overse as* Consultant Contact Details: GP Post code: Please indicate whether patient meets the following NICE criteria 1. Patient has chronic migraine (defined as headaches on at least 15 days per month of which at least 8 days are with migraine) demonstrated by a headache diary. Baseline headache days per month ( 15) Date: Baseline migraine days per month ( 8) Date: 2. Patient has not responded to at least three prior pharmacological prophylaxis therapies at least 2 of which have been given at maximum tolerated dose for a minimum of 3 months. Please provide details below: Please tick Yes No Only fully completed forms will be accepted by PCTs for consideration. If the answer to any of these questions is NO, please consider if there are patient specific exceptional clinical circumstances demonstrated. If so a full individual funding request form will need to be completed. This may be obtained from the named contact at the relevant PCT/Trust. Please refer to the individual PCT IFR policy for further details Form completed by: Start date Stop date Treatment and final dose Reason for stopping Yes No Contact details Phone: Date of completion: 3. Has this patient been assessed for medication overuse and has it been managed appropriately by reducing or stopping use? Yes No

13 FOR PCT USE ONLY Funding approved for first 2 cycles Yes No Funding will only be re-approved if there is an adequate Funding re-approved? (every 2 cycles) (Trust to provide information on number of headache days per month before and after 2 response after the initial 2 cycles. Treatment with botulinum toxin type A should be stopped in people whose condition: is not adequately responding to treatment (defined as less than a 30% treatment cycles) reduction in headache days per month after two Yes No treatment cycles) OR has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months. NICE Technology Appraisal Guidance 260 June 2012 Botulinum toxin type A for the prevention of headaches in adults with chronic migraine Guidance 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 overuse. 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. 1.3 People currently receiving botulinum toxin type A that is not recommended according to 1.1 and 1.2 should have the option to continue treatment until they and their clinician consider it appropriate to stop.