It is looking unlikely that Novartis’ Aimovig (erenumab) will be funded by the National Health Service to prevent migraine.

The National Institute for Heath and Care Excellence has now published final draft guidance confirming its earlier position not to recommend the drug for preventing chronic and episodic migraine in adults who have four episodes or more of migraine every month.

Following consultation on NICE’s earlier draft guidance, the independent committee considered new cost-effectiveness analyses from the company on the use of Aimovig in people with chronic migraine, including a proposed revised confidential commercial arrangement.

Novartis put forward Aimovig as an option when at least three previous treatments have failed.

While trial evidence shows that the drug is a clinically effective treatment compared with best supportive care, the committee remained concerned that the studies excluded people for whom all previous treatments had no therapeutic benefit. It considered this group were likely to represent the people most in need of treatment and were therefore the most clinically important subgroup.

Also, while the firm provided additional evidence to show the long-term effectiveness of the drug, the committee noted that this only included people with episodic migraine and did not specify how many treatments had failed before Aimovig, and therefore it considered this data different to the population being considered in the appraisal.

It concluded that, based on the available evidence, it was unclear whether Aimovig works in the long term, remained unaltered.

Furthermore, the Institute argued that for chronic migraine there was no direct evidence comparing Aimovig with NICE-approved botulinum toxin type A, which is considered current practice in the NHS in England.

“The indirect evidence submitted by the company is highly uncertain because of differences between trials and the lack of long-term evidence for erenumab. Therefore, the Committee reaffirmed its view that there was a high degree of uncertainty as to whether erenumab is more clinically effective than that treatment,” it explained.

Novartis said it is “very disappointed” with the decision.

“Clearly this is not the result we’ve been working towards; with chronic migraine patients in England who could benefit from Aimovig being denied routine access to this important treatment option, whilst it is NHS funded in Scotland,” said Haseeb Ahmad, managing director UK, Ireland and Nordics, Novartis Pharmaceuticals and country president UK.

“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.

“Unlike Botulinum toxin type A (Botox) which is approved by NICE for chronic migraine3, Aimovig can be self-administered 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 argued.

“We remain committed to supporting the migraine community and will continue to investigate options that could enable access to this much needed medicine.”

It is estimated that there are 190,000 migraine attacks experienced every day in England with women more likely to experience one than men (5-25% versus 2-10% respectively).