Botox, best-known for smoothing wrinkles, is to become available on the NHS to thousands of people whose lives are blighted by chronic migraines after a rethink by the drugs rationing body.
The National Institute for Health and Clinical Excellence (Nice) is to recommend the injections as a treatment to stop headaches from developing in adults who are badly affected by migraines.
In final draft guidance issued on Friday, Nice reversed its previous opposition to Botox being used for such patients. In February it said there was too little evidence to justify approving it.
But it is now backing the use of botulinum toxin type A in adults with chronic migraine whose condition has not been alleviated by taking at least three previous preventative medications and who are not overusing medication.
Botox could make a huge difference to some migraine sufferers, headache specialists predicted. "The headache experts with first-hand experience in treating chronic migraine know how debilitating the condition can be for some patients and Botox can be a life-changing treatment," said Dr Fayyaz Ahmed, chair of the British Association for the Study of Headache (Bash).
"The medical evidence shows that Botox can provide significant benefit to patients with chronic migraine, helping to reduce the number of days disrupted by migraine or headache and improving their quality of life," Ahmed added.
Sufferers who have used Botox say it helps them to undertake everyday tasks such as doing the school run, attending meetings or visiting a relative, he said.
Chronic migraine affects an estimated one in 50 people, according to the Migraine Trust. Sufferers endure a headache for at least 15 days a month, and have a migraine on at least eight of them. The Medicines and Healthcare products Regulatory Agency (MHRA) licensed Botox for that purpose in 2010.
"Although Botox may not be effective or appropriate for all patients with chronic migraine, the Migraine Trust and Bash believe that it should be available on the NHS for those patients who have been unable to manage their condition with preventative medication and who are most likely to respond to the treatment," the organisations said in a joint statement.
Nice will issue its final guidance in June, but is not expected to change its mind after its independent appraisal committee reviewed the available evidence after the watchdog's initial rejection. After that, the NHS in England and Wales will have 90 days to make Botox available when specialists recommend it. It will cost £349.40 for a 12-week cycle, and sufferers will receive injections in their head and neck.
"Chronic migraine is a disabling condition and in many cases ruins people's lives," said Wendy Thomas, chief executive of the Migraine Trust. "For patients who suffer with this condition Botox may offer a safe and effective preventative treatment option to help them manage and improve their quality of life."
Meanwhile, in a separate decision, Nice has come under fire for refusing to approve a drug, which, in some instances, can help men with advanced prostate cancer live up to three months longer.
Sir Andrew Dillon, Nice's chief executive, said at £22,000 per patient, the drug cabazitaxel, which is marketed as Jevtana, did not represent value for money for the NHS. There are also concerns about its side-effects, he added.
But prostate cancer charities criticised Nice for denying men with the disease one of the few treatments that can potentially help them live longer.
"This decision seeks to limit what we as clinicians can do for our patients and their families," said Professor Jonathan Waxman, an NHS oncologist and the clinical chair in prostate cancer at Imperial College London.
"The cost argument on which Nice bases their decision is false, giving a much higher estimate of true cost than applies in reality. As a result yet another successful and effective cancer treatment is denied our patients, a mortifying blow to cancer care in England." The Guardian
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