Cost regulators for the National Health Service in England and Wales are now recommending that patients with migraines should have access to Allergan's Botox, after initially being minded to reject its use.

The National Institute for Health and Clinical Excellence has published new draft guidance in which it endorses the use of Botox (botulinum toxin type A) to prevent chronic headaches in patients with migraine.

Things were looking a little shaky for the drug back in February after the Institute's committee of experts concluded there was insufficient evidence to back its use in the migraine setting, and so asked Allergan to provide additional information to help build a better economic case.

The extra data and analyses subsequently submitted by Allergan has enabled the Institute to recommend Botox as a treatment option for chronic migraine in adults whose condition has not responded to at least three prior preventative medications, or whose condition has been appropriately managed for medication overuse.

Based on the evidence submitted, the committee concluded that the most likely cost effectiveness estimate for Botox was £18,900 per QALY (quality-adjusted life year) gained, falling well below the £20,000-£30,000 range considered to represent value for money for the NHS.

Chronic migraine - defined as headaches on at least 15 days per month of which at least eight days are with migraine - is a debilitating condition estimated to affect around 1.6% of adults.

Effective in trials

In July 2010, the Medicines and Healthcare products Regulatory Authority licensed Botox as the first preventative treatment for chronic migraine in adults, after studies (PREEMPT 1 and 2) showed that nearly 70% of patients treated with the drug experienced a 50% reduction in migraine days, as well as a significant improvement in quality of life and headache-related disability scores compared with those given a placebo.

In addition, the treatment was found to be generally well-tolerated, with the majority of side effects mild to moderate and discontinuation rates low in both treatment arms - 3.8% in the patients receiving Botox and 1.2% in those given a placebo.

However, in April last year the Scottish Medicines Consortium refused to recommend the use of Botox for migraine prevention on the NHS in Scotland, because of "weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population".