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NICE publishes NHS draft guidance on botox as chronic migraine treatment

16th February 2012

NICE publishes NHS draft guidance on botox as chronic migraine treatment

The Department of Health has asked the National Institute for Health and Clinical Excellence (NICE) to produce guidance on using botulinum toxin type A (known commercially as BOTOX®) in the NHS in England and Wales. NICE has published draft guidance today (Thursday 16 February), which asks the company that makes BOTOX® to provide more information on using the injected drug to prevent headaches in adults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 has prepared an appraisal consultation document which summarises the evidence and views that have been considered, and sets out the draft recommendations made by the Committee. NICE is currently inviting the public and the consultees and commentators for this appraisal, to comment on this consultation document.

The NICE recommendations may change after consultation. The deadline for comments is 8 March 2012 and final NICE guidance for the NHS is expected in June 2012. For more details about the consultation and to submit comments, please visit the NICE website.

The Migraine Trust and The British Association for the Study of Headache have prepared a joint statement in response to the NICE draft guidelines:

“The Migraine Trust and the British Association for the Study of Headache (BASH) believe that all licensed migraine treatments should be made available to patients on the NHS, if their doctor believes they may benefit most from them. BOTOX® is licensed as a preventative treatment for chronic migraine and we are disappointed that NICE does not currently believe there is sufficient evidence to recommend it as an NHS treatment option. However, this is draft guidance and NICE state that it is not their final decision.  The Migraine Trust and BASH will continue to work collaboratively with NICE throughout their consultation with public and professional bodies to represent the views of headache specialists and the needs of chronic migraine patients. We urge the manufacturer and NICE to work together to source the additional evidence that the committee has requested, as it is important for migraine sufferers to have access to treatments that are proven to be effective.

Chronic migraine is a disabling condition which has a major impact on quality of life. Chronic migraine affects an estimated 2% of the population and sufferers experience headaches on 15 or more days per month, and have a migraine on at least 8 of these days. The condition can have a detrimental impact on a sufferer’s work, home and social life.

We know that BOTOX® is effective for some but not all patients who suffer from chronic migraine. We also know that many other preventative treatments are not effective for treating chronic migraine and that they can cause unacceptable side-effects. It would be extremely unfortunate if this treatment is denied to those who have exhausted all other options and those who have responded well to the treatment. The Migraine Trust advocates that this treatment should be made available to those who fail to respond to at least three preventative treatments to have a fair chance to see if BOTOX® treatment will work for them.

NHS bodies are currently making local decisions regarding NHS funding for BOTOX® treatment and some of the primary care trusts (PCTs) have already commissioned this treatment. The Migraine Trust and BASH do not want access to BOTOX® to become a postcode lottery for chronic migraine sufferers and we hope that the final NICE guidance will mean that they will have access to this treatment option on the NHS.”

For more information about BOTOX® as a preventative treatment for chronic migraine, please see our fact sheet.

The BBC News website has covered the NICE draft guidelines () and featured a quote from Wendy Thomas, Chief Executive of The Migraine Trust.

For press enquiries, please contact Kate Scurr on 020 7631 6983 /

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