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NICE Backs New Migraine Drug for Severe Cases

Thousands of people who experience episodic or chronic migraine could benefit from an additional treatment option set to be approved for routine NHS use in England and Wales.

In final draft guidance, the National Institute of Health and Care Excellence P(NICE) recommended eptinezumab (Vyepti, Lundbeck) as an option for preventing migraine in adults who have four or more migraine days a month and who have tried three other preventative drugs without success.

NICE reached its positive stance on eptinezumab after comparing benefits and costs with those of three other calcitonin gene-related peptide (CGRP) inhibitors: erenumab (Aimovig, Novartis), fremanezumab (Ajovy, Teva Pharmaceuticals), and galcanezumab (Emgality, Eli Lilly). Whereas these drugs are administered at home subcutaneously, eptinezumab is given every 12 weeks as an intravenous infusion in hospital.

Treatment Option for Severe Migraine

There are no clinical trials comparing eptinezumab with erenumab, fremanezumab, and galcanezumab, but the appraisal committee said an indirect comparison suggested that eptinezumab had similar clinical effectiveness in reducing migraine frequency in chronic or episodic cases as the other treatments. Clinical opinion was that eptinezumab should be reserved for people who experience severe migraine or who are unable to use treatments administered subcutaneously, such as those with needle phobia.

Despite requiring regular hospital visits, an analysis of drug price, discounts, dosage, and administrative work, found that the cost of eptinezumab was similar to or lower than that of the other three treatments.

Eptinezumab costs around £5870 for a year's treatment at list price, but a confidential deal with the manufacturer means the NHS can access the drug more cheaply, and this discount was made a condition of the drug receiving a positive recommendation.

In cases where two or more of the CGRP drugs are suitable, clinicians should choose the least expensive following a consultation with patients, NICE said. It estimated that around 164,000 adult patients were eligible for treatment.

Treatment with eptinezumab should be stopped after 12 weeks if the frequency of headache in patients with episodic migraine did not reduce by at least 50%, or by at least 30% in patients with chronic migraine, NICE said.

Questions Over Access

The Migraine Trust welcomed the draft guidance which it said, "improves treatment options for people affected by migraine". However, according to the charity's own research, many patients struggled to access "life-changing" CGRPs.

Rob Music, the Trust's chief executive, said: "This new class of drugs has been life-changing to many people with migraine in the UK. It has allowed many to do things that migraine had prevented them from doing, from being able to work full-time to being able to enjoy travelling. Unfortunately, too many people whose lives are currently being severely impacted by migraine, and who are eligible for these treatments, are unable to access them."

A report by The Migraine Trust in 2021 identified inequitable prescribing of CGRPs throughout the UK, and average waiting times for treatment of between 3 and 5 months.

According to Mr Music, access problems were costly to the NHS as well as the patient. He said: "Migraine causes 16,500 emergency admissions every year, at a cost of £11.5 million. As we start 2023, we hope that integrated care systems will do more to ensure that there is greater access to this potentially life changing treatment."

NICE is expected to publish final guidance on eptinezumab in March.