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Briefing Note: botulinum toxin type a (Botox)

What is botulinum toxin type A (Botox®) used for?

Botulinum toxin type A (Botox®) is licensed to treat a number of conditions. This submission relates to its use in the treatment of migraine. Migraine is a severe, painful headache that is often preceded or accompanied by flashes of light, blind spots, tingling in the arms and legs, nausea, vomiting, and increased sensitivity to light and sound. The pain can last for hours or even days. Migraine results from enlargement of blood vessels and the release of chemicals from nerve fibres surrounding these blood vessels.

The submitting company has requested that SMC considers the use of botulinum toxin type A (Botox®) when used in patients with chronic migraine whose condition has failed to respond to more than three prior oral prophylactic (preventative) treatments, where medication overuse has been appropriately managed and who are under the care of a headache specialist in a secondary care centre.

How does it work?

Botulinum toxin type A (Botox®) can prevent headaches associated with migraine. It works by paralysing the muscles of the head and neck that trigger migraines. It can be injected into superficial muscles (under the skin) and deep muscles of the head and neck. Injections should be divided across seven specific head/neck muscle areas and can be given every 12 weeks.

What has SMC advised?

SMC has not recommended botulinum toxin type A (Botox®) for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).

What is the evidence to support this?

  • Combining the results of two studies showed that botulinum toxin type A (Botox®) significantly reduced the frequency of headache days compared with placebo (a dummy medicine containing no active treatment).
  • An economic analysis compared botulinum toxin type A (Botox®) injections with best supportive care in a subset of patients experiencing chronic migraine. Given the number of uncertainties in the analysis, it was not considered to offer value for money.

SMC did not recommend botulinum toxin type A (Botox®) for use because the balance of costs and benefits meant that it was not considered to offer value for money.