Should the NHS offer Botox as a treatment option for chronic migraines? NICE asks for more evidence
The National Institute for Health and Clinical Excellence (NICE) has published draft guidance today (Thursday 16 February), which asks the company that makes Botox (botulinum toxin type A) to provide more information on using the injected drug to prevent headaches in adults with chronic migraine. NICE's independent committee of experts does not believe that the evidence already provided by the manufacturer, Allergan is sufficient for it to develop guidance for the NHS; and so without additional information, it is inclined not to recommend Botox as a treatment option.
NICE, the healthcare guidance body has been asked to produce guidance for the NHS on whether Botox should be considered as a treatment option for adults who experience headaches associated with chronic migraine and whose condition has not improved after at least three prior preventive medications. These adults must have had their medication overuse appropriately managed.
A chronic migraine is defined as having headaches for at least 15 days a month over three months, of which 8 of these days are with migraine. Chronic migraines are believed to affect 1.6% of adults.
NICE's committee met last month to review the evidence provided by Allergan. It found that although the clinical trials demonstrated that Botox was shown to have some benefit, the amount of benefit was small and the results were confounded by a large placebo effect. This is because the people in the trials may have realised that they were receiving Botox due to its widely-recognised side effects (i.e. muscle paralysis). The committee also noted that the long term effectiveness of Botox is uncertain.
In terms of its cost effectiveness, the committee asks Allergan to revise its economic modelling and analyses to clarify uncertainties regarding some of the model inputs and assumptions.
Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said: "Our independent committee is asking Allergan to provide further information and analysis as part of this public consultation, so that it has sufficient evidence to develop sound advice for the NHS regarding the use of Botox for the prevention of headaches in adults with chronic migraine.
"Without this additional evidence, potentially we will be unable to advise the NHS that this drug is good value for money for these adults because there are currently too many uncertainties. Until we publish our final guidance, NHS bodies should continue to make decisions locally on the funding of specific treatments."
The deadline for comments received is 5pm on 8 March 2012. The Committee will meet again in March to review the additional evidence and the comments from consultation. Final guidance for the NHS is expected in June 2012.
Notes to Editors
About the draft guidance (appraisal consultation document, ACD)
1. For further information about the ACD on 'Botulinum toxin type A for the prophylaxis of headaches associated with chronic migraine', visit: http://guidance.nice.org.uk/TA/Wave26/9. Please contact the NICE Press Office for an embargoed copy of the draft guidance.
2. Botulinum toxin type A (Botox, Allergan) is a purified neurotoxin complex which produces seven neurotoxins that are structurally similar but immunologically distinct. It has neuromuscular transmitter blocking effects. The recommended reconstituted dose is 155-195 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. The net price of a 200 unit vial is £276.40, excluding VAT. Allergan estimates that the administration cost is £73 per treatment, based on a total treatment time of less than 30 minutes; therefore, the total cost for treatment and administration of treatment per 12 week cycle, assuming no vial sharing, is expected to be £349.40. Costs may vary in different settings because of negotiated procurement discounts.
3. NICE's technology appraisal will apply to NHS settings in England and Wales. In April 2011, the Scottish Medicines Consortium (SMC) advised NHS Scotland not to offer botulinum toxin type A for the prophylaxis of headaches in adults with chronic migraine.
4. Once published, this technology appraisal will be the first time that NICE will have published guidance on the use of botulinum toxin type A for any condition.
5. Based on the current evidence presented, NICE's Committee was unable to determine whether Botox was a cost effective use of NHS resources compared to standard care, and so has requested further revision and clarification.
6. No Patient Access Scheme has been proposed for this treatment and end-of-life considerations do not apply for this technology appraisal.
1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
3. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.