The draft guidance looks at erenumab (also called Aimovig and made by Novartis) for preventing chronic and episodic migraine in adults who have 4 episodes or more of migraine every month and where at least 3 other preventive treatments haven’t worked.
Costing around £5,000 per patient per year at its list price, erenumab targets the process by which proteins cause blood vessels in the brain to swell, leading to the symptoms associated with migraines. It is given every 4 weeks as a self-administered injection.
Following consultation on NICE’s earlier draft guidance, the independent committee considered new cost-effectiveness analyses from the company on the use of erenumab in people with chronic migraine. This incorporated a proposed revised confidential commercial arrangement.
The evidence shows that erenumab is a clinically effective treatment compared with best supportive care. However, the committee remained concerned that the clinical trials didn’t include people who had already unsuccessfully tried other preventive treatments – a group the committee felt were most in need of treatment.
The company provided additional evidence to show the long-term effectiveness of erenumab, However, the committee was concerned that this only included people with episodic migraine and did not specify how many treatments had failed before erenumab. The committee therefore considered this data referred to a different population than that being considered in the appraisal. The committee’s conclusion that, based on the available evidence, it was unclear whether erenumab works in the long term, remained unaltered.
For chronic migraine there was no direct evidence comparing erenumab with NICE-approved botulinum toxin type A which is considered current practice in the NHS in England. 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.
The company did not submit any updated cost-effectiveness analysis for episodic migraine.
Because of these factors, and after considering the proposed new commercial arrangement, the cost-effectiveness estimates for erenumab remain higher than what NICE usually considers to be acceptable.
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).
Treatments aim to reduce how often migraines happen, how bad they are or how long they last, and improve the person’s quality of life. Current treatments for preventing migraine include drugs that are used for treating other conditions, such as beta-blockers, antidepressants and epilepsy medicines. The patient experts explained that these treatments can have significant side-effects and don’t work for some people.
Usually at least 3 oral preventive treatments will be tried before more specialist treatment is considered. For people with chronic migraine for whom at least 3 previous preventive oral treatments have failed, NICE has recommended botulinum toxin type A (NICE technology appraisal guidance 260) as an option.
Registered consultees, including the company and patient and professional groups, now have the opportunity to appeal against the draft guidance. If no appeals are received NICE expects to publish its final guidance on erenumab next month.