Aimovig® (erenumab) NICE Final Appraisal Document (FAD) publication – Novartis UK media statement

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Dec 11, 2020

London, UK, December 11, 2020 — We at Novartis UK are pleased that the National Institute for Health and Care Excellence (NICE) has reconsidered its previous decision for Aimovig® (erenumab), today publishing a Final Appraisal Document (FAD) that recommends Aimovig for preventing migraine*. The decision confirms that people in England and Wales living with four or more migraine days per month for whom at least three prior preventive drug treatments have failed, are now one step closer to having routine access to this treatment through the National Health Service (NHS)1.

Aimovig can be self-administered at home every four weeks, and has proven to be well-tolerated and effective in reducing mean monthly migraine days across the spectrum of migraine, with many patients achieving a 30% or greater reduction2.

We acknowledge that NHS resources are limited and that several other, oral preventive migraine treatment options should be tried first. This is why Aimovig is positioned for migraine patients for whom multiple prior preventive treatments have failed, reflecting the continuing need for effective and well-tolerated preventive migraine treatment options in the UK1.

Based on further analyses submitted by Novartis, NICE found Aimovig has a benefit compared with placebo that goes beyond a reduction in monthly migraine days, and that it is plausible that Aimovig may work better than botulinum toxin. Taking these considerations into account, NICE concluded that Aimovig is a cost-effective treatment option for people with episodic and chronic migraine after three preventive treatments have failed1.

Novartis appreciates the opportunity to provide the additional data that NICE required, alongside NICE’s recognition of the importance of maintaining consistency of preferred assumptions across appraisals, which have led to today’s recommendation for Aimovig. We also acknowledge the role and continued efforts of the British Association for the Study of Headache (BASH) and the Association of British Neurologists (ABN) in supporting the NICE appraisal of Aimovig.

“People living with the debilitating impact of migraine have waited many years for targeted preventive treatments,” said Chinmay Bhatt, Managing Director UK, Ireland and Nordics, Novartis Pharmaceuticals. “Our focus now is to continue working with NICE and the NHS to ensure Aimovig is made available to those that could benefit as quickly as possible, so we can begin to help reduce the burden of migraine on individuals, hospital resources and broader society.”

* This is the final recommendation from the National Institute for Health and Care Excellence (NICE). The Final Appraisal Document (FAD) forms the basis of the final guidance that NICE issues to the NHS. The FAD is subject to factual accuracy check and subject to appeal if requested by stakeholders involved. Following this process which can take up to 3 months, the Technology Appraisal Guidance (TAG) is formed on the basis of the FAD and represents the formal published guidance from NICE. Clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities, must comply with the NICE TAG that recommends the relevant health service body provides funding within the period specified.

UK | December 2020 | 101863

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Novartis UK Media Relations
Novartis UK Press Office
Tel: 07771 541379
E-Mail: [email protected]

References

  1. National Institute for Health and Care Excellence. Final Appraisal Document. Erenumab for preventing migraine. December 2020. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10302/documents. Last accessed December 2020.

  2. European Medicines Agency (EMA). Aimovig – Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/004447/WC500253553.pdf. Last accessed December 2020.