NICE rejects Novartis’ migraine prevention drug Aimovig

Some migraine sufferers in the UK hoping to get access to Novartis’ new migraine prevention drug Aimovig are facing disappointment after NICE rejected it in draft guidance.

The cost-effectiveness watchdog says that it can’t recommend routine NHS use of Aimovig (erenumab) for people suffering at least four migraine episodes each month, even though it is only intended for use after three earlier oral treatments have failed.

Aimovig became the first drug in a new class of antibody-based CGRP inhibitors to be approved in Europe when it got a green light from the European Medicines Agency (EMA) last year, and is designed as a once-monthly, self-injected preventive treatment for migraines.

Since then Eli Lilly has won EU approval for its CGRP blocker Emgality (galcanezumab), while Teva is waiting for an EMA verdict on its fremanezumab candidate and Alder Biopharma is preparing a marketing application for eptinezumab.

Aimovig costs around £5,000 per year, although Novartis has offered the NHS a confidential discount, but NICE’s concerns seem to focus as much on deficiencies in the data generated in clinical trials as its price.

“The evidence shows that erenumab is a clinically effective treatment,” said NICE in a statement, but it added that “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 the cost-effectiveness estimates for erenumab are higher than what NICE usually considers to be acceptable when there is substantial uncertainty,” it added, noting in particular that there was not enough evidence to suggest it is more effective than that of Allergan’s Botox (botulinum toxin type A) for chronic migraine, which has been recommended for use after three failed treatments since 2012.

Novartis maintains people with chronic migraine have been waiting years for something “new, more effective and better tolerated”, pointing out that Botox “requires 31-39 injections into the head and neck in a clinic while Aimovig can be self-administered by the patient at home.”

The company’s managing director for the UK and Ireland – Haseeb Ahmad – described the decision as disappointing and said the company would be discussing its submission with NICE.

“If this decision remains unchanged patients will be denied access to the first licensed treatment specifically designed to prevent migraine in adults,” he added, suggesting NICE’s appraisals are flawed because they don’t take into account the impact of diseases on broader society when evaluating cost-effectiveness.

Novartis also says that as migraine predominantly affects people of working age, it costs the UK economy £8.8 billion per year in lost productivity alone.

Commenting on NICE’s decision, Meindert Boysen – director of the agency’s Centre for Health Technology Evaluation – said that “well-tolerated treatment options are needed [and] it’s therefore disappointing that we’ve not been able to make a positive recommendation for erenumab.”

“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 three previous preventive treatments had failed,” he added.

That NICE draft guidance is out for comment until 31 January. Meanwhile, the Scottish Medicines Consortium (SMC) is scheduled to deliver advice on NHS use of Aimovig in Scotland in April.