Fremanezumab (Ajovy) can now be routinely prescribed on the NHS in England and Wales for patients with chronic migraine in whom at least 3 preventive drug treatments have failed.
Chronic migraine is defined as 15 or more headache days a month for more than 3 months, with at least 8 of those having features of migraine.
Already approved for NHS use in Scotland, fremanezumab belongs to a new class of migraine preventives targeting calcitonin gene-related peptide (CGRP). It is administered monthly by subcutaneous self-injection and works by targeting the process by which proteins cause blood vessels in the brain to swell.
The drug should be stopped if migraine frequency does not reduce by at least 30% after 12 weeks of treatment.
NICE's approval is contingent on the manufacturer, Teva, providing the drug with the agreed discount. Fremanezumab costs around £5000 per year at its list price.
Quality of life
In its assessment, NICE said it recognised the substantial burden that migraine has on quality of life and day-to-day functioning, and acknowledged that this could lead to psychosocial issues. The guideline committee concluded that fremanezumab is clinically effective compared with best supportive care, although it was uncertain whether the drug is more effective than botulinum toxin type A.
Commenting on the initial draft NICE approval earlier this year, Gus Baldwin, chief executive of The Migraine Trust, said: 'We are delighted that for the first time chronic migraine patients across England and Wales will be able to access an effective drug on the NHS that has been specifically designed to prevent migraine attacks.
'We are particularly pleased that the patient evidence we submitted to NICE was referenced as a supporting factor in the approval granted today. Many people we spoke to told us this drug had been ‘life-changing’ for them.'
Another CGRP inhibitor, erenumab (Aimovig) is also available for restricted use within NHS Scotland but was rejected by NICE in draft guidance issued in 2019.