NICE has today (10 January) published draft guidance for public consultation which does not recommend erenumab (Aimovig, Novartis) for preventing migraine.
The draft guidance looks at erenumab for preventing chronic and episodic migraine (as defined by the International Headache Society) in adults who have 4 episodes or more of migraine every month where at least 3 previous preventive treatments have failed.
The evidence shows that erenumab is a clinically effective treatment. However, the committee considered 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.
Erenumab is the first treatment to target the process by which proteins cause blood vessels in the brain to swell, leading to the symptoms associated with migraines. It is given as a monthly self-administered injection.
Erenumab costs around £5000 per year at its list price, although a confidential commercial arrangement has been agreed with the company which would have made it available at a discounted price.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: “Migraine is a debilitating condition that significantly affects quality of life and the committee heard from patient experts that well-tolerated treatment options are needed. It’s therefore disappointing that we’ve not been able to make a positive recommendation for erenumab.
“Erenumab is a promising new preventive treatment for migraine that has been shown to be clinically effective compared with best supportive care. However, there was not enough evidence to suggest that it is more effective than botulinum toxin type A for people with chronic migraine, which NICE already recommends. And 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 3 previous preventive treatments had failed.
“We will work with the company to ensure that they are given every opportunity to address the issues highlighted in these provisional recommendations.”
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).
The aim of treatment is to reduce the frequency, severity or duration of migraine and improve quality of life. Current treatment options for preventing migraine include drugs that are used for treating other conditions, such as beta-blockers, antidepressants and epilepsy medications. The patient experts explained that these treatments can have significant side-effects and can be ineffective 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 ( ) as an option.
The closing date for comments on the draft recommendations is 31 January 2019.