A ‘LIFE-CHANGING’ migraine drug has been rejected for use on the NHS.
Critics of the decision said it marks a “very bad day” for those plagued by chronic migraines.
The National Institute for Health And Care Excellence (Nice) first rejected Erenumab, also known by the name Aimovig, in January.
But today it has confirmed that decision in a final ruling.
The drug was approved for use in Europe last year, as the first specifically designed to prevent migraine.
In April, the Scottish Medicines Consortium announced the drug would be given the green light, for adults who have tried three previous treatments, that have failed.
It works by blocking a gene receptor, which is thought to play a critical role in the debilitating condition.
Botox ‘just as good’
But Nice said today there is not enough evidence that the drug works better than Botox, which is available to sufferers on the NHS.
The watchdog said it has concerns about the patients included in trials run by the drugs’ firm Novartis.
It said it fears the trials excluded people who had found all previous treatment failed.
“This group were likely to represent the people most in need of treatment and were therefore the most clinically important subgroup,” Nice said.
Nice also said it is not clear whether Erenumab works in the long-term, and added there was no evidence from Norvartis trials comparing the drug with Botox.
Nice concluded there was “a high degree of uncertainty as to whether Erenumab is more clinically effective” than Botox.
‘Very bad day’ for sufferers
But Gus Baldwin, chief executive of The Migraine Trust, said: “This still feels like a very bad day for chronic migraine patients.”
Haseeb Ahmad, UK managing director of Novartis, said the firm was “very disappointed” by the move.
He added: “This decision is particularly disappointing given Nice has recognised the clinical effectiveness and tolerability of Aimovig in chronic migraine, and there remains an unmet need for effective and well-tolerated preventive migraine treatments in the UK.”
He said unlike Botox, the drug can be injected at home and does not require repeated clinic visits or multiple injections into the head and neck.
“Furthermore, treatment with Botox may not be appropriate for everyone that lives with the devastating impact of chronic migraine,” he said.
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“Novartis has a track record of going above and beyond when it comes to working with reimbursement agencies, and we understand the need for companies to be flexible in order to make new medicines readily available.
“As such, we have been working closely with Nice to come to an agreement on an access scheme for Aimovig.
“Despite further improving our commercial proposition, within the parameters of the Nice appraisal process, the committee felt there to be remaining uncertainty in the evidence and were therefore unable to give a positive final appraisal determination recommendation.
“We believe in the benefits that Aimovig offers, and we appreciate how disappointing this news will be for those who have waited many years for a targeted preventive treatment to be made widely available .”
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