NICE rejects Novartis Aimovig for prevention of migraine

NICE rejects Novartis Aimovig for prevention of migraine

NICE rejects Novartis Aimovig for prevention of migraine in draft guidance published today. Novartis and NICE have both expressed disappointment, saying they will work together to address outstanding questions.

The National Institute for Health and Care Excellence (NICE) has published draft guidance for public consultation which does not recommend Aimovig® (erenumab) for the prevention of migraine.

The draft guidance looks at erenumab for preventing chronic and episodic migraine in adults who have four episodes or more of migraine every month where at least three previous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.

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 three oral preventive treatments will be tried before more specialist treatment is considered. For people with chronic migraine for whom at least three previous preventive oral treatments have failed, NICE has recommended botulinum toxin type A (NICE technology appraisal guidance 260 ) as an option.

Commenting on the decision, Haseeb Ahmad, Country President of Novartis UK and Managing Director (UK & Ireland) of Novartis Pharmaceuticals said: “We’re disappointed by this initial decision from the National Institute for Health and Care Excellence (NICE) to not recommend Aimovig® (erenumab) for routine use on the NHS, yet welcome the opportunity to further discuss our submission. If this decision remains unchanged patients will be denied access to the first licensed treatment specifically designed to prevent migraine in adults.

“Many migraine patients remain dissatisfied with their current treatment options and have been waiting years for new developments. NICE has recognised the clinical-effectiveness of Aimovig and that a significant unmet treatment need exists for people living with migraine in the UK. Our priority now is to continue working closely with NICE to address any outstanding questions they have in order to secure access to this innovative treatment for anyone that could benefit from Aimovig, as quickly as possible.

“NICE does not consider the impact of diseases on broader society when evaluating the cost-effectiveness of medicines. We believe this fails to capture the true value of medicines like Aimovig. As migraine predominantly affects people of working age, it costs the UK economy £8.8 billion per year in lost productivity alone.

“There are also important quality of life benefits for patients that must be considered. Unlike Botulinum toxin type A (Botox), Aimovig can be self-administered at home, and does not require repeated clinic visits or multiple injections into the head and neck.”

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 three 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.”

The closing date for comments on the draft recommendations is 31 January 2019.