National Institute for Health and Care Excellence (NICE) on Thursday rejected Novartis’s migraine drug Aimovig (erenumab) for now, concluding in a draft decision that the medicine was not a cost-effective use of NHS resources.

Novartis, with exclusive rights to the drug in Europe while cooperating with Amgen in the United States, said they were “disappointed” in the conclusion, a sentiment shared by NICE also, which termed the drug as “clinically effective.”

Costing around £5,000 (£3900) per year erenumab, given as an injection administered by patients themselves, is the first treatment to target the process by which proteins cause blood vessels in the brain to swell, leading to the symptoms of migraine.

NICE said the clinical trial evidence for the drug doesn’t fully reflect patients seen in the NHS and nor does it include all the relevant comparisons with other drugs 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 in the evidence, it added.

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 treatments are needed. It’s therefore disappointing that we’ve not been able to make a positive recommendation for erenumab.

“We will work with the company to ensure that they are given every opportunity to address the issues highlighted in these provisional recommendations.”

Haseeb Ahmad, country president of Novartis UK, said: “We’re disappointed by this initial decision from the National Institute for Health and Care Excellence 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.””

“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.”

The NICE draft guidance is open for consultation until 31 January 2019.

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