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to get access to Novartis’ new migraine prevention drug Aimovig are facing disappointment after NICE rejected it in the draft guidance.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, 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.”