LONDON May 11 Britain's healthcare cost-effectiveness body NICE has changed its mind on Allergan's anti-wrinkle injection Botox and decided it is worth paying for on the state-funded health service for some patients suffering migraines.
Botox is licensed to prevent headaches in adults with chronic migraine but the National Institute for Health and Clinical Excellence (NICE) had previously said it was not convinced of the value of funding the treatment on the country's National Health Service (NHS).
In a reversal on Friday, NICE said that after asking Allergan for more information, its independent committee was issuing draft guidance recommending Botox, also known as Botulinum toxin type A, as a treatment option for some patients.
"Chronic migraines are extremely debilitating and can significantly affect a person's quality of life," said Carole Longson, NICE's director of health technology evaluation.
"We are pleased that the committee has been able to recommend Botox as a preventative therapy for those adults whose headaches have not improved despite trying at least three other medications and whose headaches are not caused by medication overuse."
According to pricing and dosing information supplied by Allergan, the total cost for treatment and administration of treatment for a 12 week cycle is estimated at just over 349 pounds ($560), NICE's statement said.
Allergan said NICE's decision "means that headache specialists in England and Wales will have a cost-effective, well-tolerated and licensed prophylactic treatment to help manage this debilitating condition".
The firm said in a statement that while there were an estimated 700,000 adults in the UK with chronic migraine, only 20 percent of people with the condition were properly diagnosed.
It estimated that about a third of diagnosed patients with chronic migraine had already tried three or more preventative medications and may now be eligible for treatment with Botox.
NICE's guidance recommends Botox injections should be stopped if a patient's headaches don't improve enough after two treatment cycles, or if a patient's "headache days" have reduced to fewer than 15 days a month over three consecutive months.
SANOFI'S JEVTANA REBUFFED
In a separate statement, NICE confirmed its decision not to recommend use of Sanofi's prostate cancer drug Jevtana on Britain's state health service, given its limited ability to extend life, its side effects and its cost.
Jevtana is licensed for use in both Europe and the United States after clinical trials showed it helped men with advanced prostate cancer when given alongside the anti-inflammatory drug prednisone.
NICE had previously recommended against funding Jevtana, known generically as cabazitaxel, but that draft guidance was appealed.
On Friday NICE said the appeal had failed. "Although cabazitaxel can extend life for some patients, its price remains well above what the independent committee appraising this drug considered acceptable, given the benefits it offers," NICE's chief executive Andrew Dillon said in the statement.