Allergan’s Botox (botulinum toxin type A) has been recommended in final NICE guidance as a treatment option for adults who experience chronic migraine.

The popular cosmetic injection has been recommended in adults whose condition has not responded to three other preventative medicines but has previously been appropriately managed.

Professor Carole Longson, Director of the Heath Technology Evaluation Centre at NICE, said the Institute was pleased to recommend Botox for the “extremely debilitating” condition.

The guidance recommends Botox may be used on the NHS as an option unless a patient’s headaches have not improved after two cycles of treatment. Also, if a person’s ‘headache days’ have reduced to fewer than 15 days a month over three months then treatment should stop.

A chronic migraine is defined as headaches on at least 15 days per month, of which at least 8 days are with a migraine. It’s believed that around 1.6% of adults are affected with the condition.

The guidance applies to NHS settings in England and Wales. In April last year, the Scottish Medicines Consortium advised against the use of the injection to treat the condition.

Allergan’s Botox has been recommended in final draft guidance as an option for the NHS to prevent headaches in certain adults who experience chronic migraine.

NICE advises the injection can be used in patients whose condition has not responded to three prior preventative medications and whose conditions has been appropriately managed.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said Botox is a “preventative therapy” for those with “extremely debilitating” chronic migraines.

In February, NICE failed to recommend the injection after questioning the evidence supplied by Allergan.

However, after additional information and analysis were supplied by Allergan, NICE’s independent Appraisal Committee deemed the treatment to be a good use of NHS resources.

The draft guidance adds that injections of the popular cosmetic treatment should be stopped if headaches have not improved enough after two cycles, or if the amount of “headache days” falls to fewer than 15 per month, over three consecutive months.

Chronic migraines are believed to affect around 1.6% of adults. They are defined as headaches on at least 15 days per month, of which at least 8 are with migraine.

The draft guidance is now open for consultation with final guidance expected in June.

NICE has requested further information from Allergan on the use of Botox (botulinum toxin type A) to prevent headaches in adults with chronic migraines after failing to recommend its use in draft guidance.

The Institute’s Appraisal Committee does not believe the evidence supplied is sufficient for it to develop guidance after queries were raised over its cost effectiveness compared to existing treatments.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, says further information is required to develop “sound advice” to the health service.

The guidance analysed whether Botox should be considered as a treatment option for those who experience headaches associated with chronic migraine, and whose condition has not improved after at least three previous preventative treatments.

A chronic migraine, which is believed to affect 1.6% of adults, is defined as having a headache for at least 15 days a month over a period of three months, of which eight of the days are with a migraine.

Evidence demonstrated in clinical trials showed that Botox does have some benefit. But the amount of benefit proved to be small and the results were confounded by a large placebo effect, NICE found. This was due to people realising during clinical trials that they were receiving the injection due to its widely-recognised side effects, such as muscle paralysis. Concerns were also raised by the Committee into the long-term effectiveness of Botox.

NICE has now requested additional data on the injection’s cost effectiveness and asked Allergan to revise its economic modelling and analyses to clarity uncertainties over certain inputs and assumptions made in its cost model.

“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,” said Professor Longson.

The deadline for consultations on the draft guidance is 8 March 2012. Final guidance is expected in June 2012.