NICE holds out for more data on Botox for migraine

The U.K.'s cost-effectiveness watchdog is looking askance at Botox for chronic migraine. The National Institute for Health and Clinical Excellence has asked Allergan ($AGN) for more data to back up its contention that the injectable drug, best known for its cosmetic use, actually benefits patients who suffer from the debilitating headaches.

NICE said that the Botox injections--given every 12 weeks in at least 31 sites around the head and neck--appears to have "some benefit." But the clinical trials showed the benefit was small, and the data could have been biased, the agency said. "Our independent committee is asking Allergan to provide further information and analysis ... so that it has sufficient evidence to develop sound advice," NICE's Carole Longson said. "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."

Allergan said it was "working constructively" to address NICE's concerns. New evidence for the agency will show "that treatment with Botox is both a cost effective and clinically meaningful treatment option for patients suffering from this debilitating condition." NICE estimated that the cost of the Botox injections would be about £350, or about $550, for each round.

The U.S.-based drugmaker is looking to medical uses of Botox to pump up sales of the drug going forward. A form of the botulinum toxin, Botox is commonly used to fight wrinkles, but it's also approved to treat muscle spasticity, to prevent migraine, and to treat incontinence in patients with spinal cord injuries or certain neurological disorders. The company is aiming for a more general overactive-bladder indication as well. Sanford C. Bernstein analysts have said that the migraine use could help to almost double Botox's annual sales to $2.3 billion, Bloomberg notes.

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