NICE’s draft guidance recommends Botox for adults with chronic migraine who have failed previous treatment


Botox could soon become a NHS treatment option to prevent headaches in some adults who experience chronic migraine. The National Institute for Health and Clinical Excellence (NICE) published its final draft guidance on Friday 11 May which recommends the injections for the condition.

NICE has been asked to advise the NHS on whether the benefits of Botox (known chemically as botulinum toxin type A and manufactured by Allergan) for chronic migraine are value for money. In February, NICE asked Allergan to provide more information and analyses as part of a public consultation on its draft recommendations. Allergan provided this information and NICE’s independent appraisal committee is now able to recommends Botox in the final draft guidance as a treatment option for chronic migraine in adults whose condition has not responded to taking at least three prior preventative medications and in adults whose condition has been appropriately managed for medication overuse.

The draft guidance recommends that Botox injections should be stopped if the person’s headaches have not improved enough after two treatment cycles, or if the person’s “headache days” have reduced to fewer than 15 days a month over three consecutive months—this is because if a person’s headache days have reduced to fewer than 15 a month, they will have a different type of migraine (called episodic migraine), which is not covered in Allergan’s licence for Botox. Botox is licensed for adults with chronic migraine.

Carole Longson, director of the Health Technology Evaluation Centre at NICE said: “Chronic migraines are extremely debilitating and can significantly affect a person’s quality of life. We are pleased that the committee has been able to recommend Botox as a preventative therapy for those adults whose headaches have not improved despite trying at least three other medications and whose headaches are not caused by medication overuse. 
“We have published our final draft guidance so that registered stakeholders can highlight any factual errors or appeal against our provisional recommendations. We have not yet issued guidance to the NHS on the use of this drug.”

In a press release by Allergan, Fayyaz Ahmed, chair of the British Association for the Study of Headache (BASH) said:  “The medical evidence shows that Botox can provide significant benefit to patients with chronic migraine, helping to reduce the number of days disrupted by migraine or headache and improving their quality of life. Those who respond to Botox describe the treatment as life changing and for refractory patients who have exhausted other options, a reduction in the number of headache days can have a very significant impact on everyday life, like being able to do the school run, attend a meeting or visit relatives. As headache experts with first-hand experience of treating chronic migraine patients, the final draft guidance by NICE is welcomed.”

Once the final guidance has been published, the NHS must allocate funding for the use of Botox as defined in the guidance within three months. This is in accordance with the NHS Constitution, which outlines what staff, patients and the public should expect from the NHS.

NICE has announced that registered stakeholders wishing to appeal NICE’s draft recommendations have until Friday 25 May to do so. If no appeals are received, NICE hopes to publish its final guidance for the NHS in June 2012. Until final guidance is issued, NHS bodies should continue to make decisions locally on whether to fund the treatment.