A migraine drug that some patients describe as “life changing” has been rejected for use on the NHS.
The National Institute for Health and Care Excellence (Nice) first rejected Erenumab in draft guidance in January, but has now confirmed its decision in a final document.
Erenumab, also known by the name Aimovig, was approved for use in Europe last year as the first treatment specifically designed to prevent migraine.
The monoclonal antibody works by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine.
But Nice has said there is insufficient evidence that the drug works better than Botox, which is available on the NHS, and said it had concerns about the type of patients in clinical trials run by Novartis.
Nice looked at Erenumab for preventing chronic and episodic migraine in adults who have four migraines a month or more.
Current medications for preventing migraine include beta-blockers,
antidepressants and epilepsy drugs.
If chronic migraine does not respond to at least three preventive drug treatments, Botox is usually offered.
Nice said it was concerned that clinical trials of Erenumab excluded people for whom all previous treatments had no therapeutic benefit.
It said “this group were likely to represent the people most in need of treatment and were therefore the most clinically important subgroup”.
Nice also said it was unclear whether Erenumab works in the long-term and there was no direct evidence from Novartis comparing Erenumab with Botox.
Nice concluded there was “a high degree of uncertainty as to whether Erenumab is more clinically effective” than Botox.
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.
“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 .”
Gus Baldwin, chief executive of The Migraine Trust, said: “This still feels like a very bad day for chronic migraine patients.”