NICE frowns on Botox for headache prevention
pharmafile | February 16, 2012 | News story | Sales and Marketing | Allergan, Botox, EMA, NHS, NICE
NICE is not recommending Allergan’s Botox for headache prevention, and has asked the firm for more information on the drug.
The watchdog said in draft guidance it would not recommend Botox (botulinium toxin type A) for the prevention of headaches in people with chronic migraine after treatment with three prior therapies.
NICE said it wanted more information from Allergan, including factoring in an out-patient follow up cost of £140 for those taking the drug, and a ‘stopping rule’ for those on the treatment who’s headaches get better, or worse.
NICE also concluded that clinical trials demonstrated that Botox produced some benefit, this was small and the results were made more doubtful by problems with the trial design.
The watchdog also noted that the long-term effectiveness of Botox is uncertain. The estimated cost to the NHS would be £349.40 for every 12-week cycle of treatment.
Professor Carole Longson, director of the health technology evaluation centre at NICE, said: “Our independent committee is asking Allergan to provide further information and analysis as part of this public consultation, so that it has sufficient evidence to develop sound advice for the NHS regarding the use of Botox for the prevention of headaches in adults with chronic migraine.
“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.”
The Scottish Medicines Consortium said last year that it wouldn’t recommend Botox for use on the NHS in Scotland due to “weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population”.
Allergan said it was ‘working constructively’ with NICE and would provide new evidence that would demonstrate: “Botox is both a cost effective and clinically meaningful treatment option for patients suffering from this debilitating condition.”
The drug is best known for its use as an anti-wrinkle treatment, but in recent years Allergan has gained new licences for the treatment to broaden its use.
This includes approval from the Medicines and Healthcare Products Regulatory in 2010 for use as a headache prophylaxis, and last year’s FDA approval for use in patients with urinary incontinence.
There will be a second NICE meeting on the drug in March, with a final decision expected to be reached by June.
Ben Adams
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