More data needed on Botox

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(botulinum toxin type A) to prevent headaches in adults with chronic migraines after failing to recommend its use in draft guidance.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The deadline for consultations on the draft guidance is 8 March 2012.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.