The National Institute for Health and Care Excellence (NICE) has rejected NHS funding for Novartis’ Aimovig (erenumab) as preventative treatment for migraine in draft guidelines.

The drug was approved for use in Europe in July last year as the region's first treatment specifically designed to prevent migraine.

The monoclonal antibody offers patients a novel therapeutic approach as the first to block the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine.

Its mode of action differs from other similar migraine therapies in development, which target CGRP itself as opposed to the receptor pathway.

The rejection comes despite a Phase IIIb LIBERTY trial, which assessed Aimovig in episodic migraine patients who had previously tried two to four therapies without success, showing that patients taking the drug had almost three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).

However, NICE's committee felt the trial evidence "doesn’t fully reflect patients seen in clinical practice in the NHS and nor does it include all the relevant comparators and outcomes". Because of this, cost-effectiveness estimates for the drug are higher than what is normally considered to be acceptable when there is substantial uncertainty, it said.

“Erenumab is a promising new preventive treatment for migraine that has been shown to be clinically effective compared with best supportive care. However, there was not enough evidence to suggest that it is more effective than botulinum toxin type A for people with chronic migraine, which NICE already recommends," explained Meindert Boysen, director of the Centre for Health Technology Evaluation at the Institute. "And for both the chronic and episodic migraine populations there was no evidence to show that erenumab is effective in the long-term in people for whom 3 previous preventive treatments had failed."

“We’re disappointed by this initial decision from the National Institute for Health and Care Excellence to not recommend Aimovig for routine use on the NHS, yet welcome the opportunity to further discuss our submission," said Haseeb Ahmad, country president of Novartis UK and managing director (UK & Ireland) of Novartis Pharmaceuticals. "If this decision remains unchanged patients will be denied access to the first licensed treatment specifically designed to prevent migraine in adults.

"Many migraine patients remain dissatisfied with their current treatment options and have been waiting years for new developments. NICE has recognised the clinical-effectiveness of Aimovig and that a significant unmet treatment need exists for people living with migraine in the UK. Our priority now is to continue working closely with NICE to address any outstanding questions they have in order to secure access to this innovative treatment for anyone that could benefit from Aimovig, as quickly as possible.

Migraine is a debilitating condition that significantly affects quality of life. Over 610,000 people in the UK are estimated to experience chronic migraine, with the 2010 Equality Act classing migraine as a disability should the condition have a long term, substantial impact on day to day or work-related activities.