NICE Draft Guidance Rejects Amgen/Novartis’ Aimovig for Migraine Prevention Over Cost-Effectiveness Concerns

Compiled by Fan Dongdong

Recently, the UK’s National Institute for Health and Care Excellence (NICE) issued draft guidance rejecting the use of Amgen/Novartis’ Aimovig for the prevention of migraine in adult patients who experience at least four migraine days per month. The rejection was based on the regulator’s determination that the therapy does not represent a cost-effective use of resources.

NICE is concerned that the clinical data for Aimovig are insufficient to warrant a positive recommendation, despite the drug’s annual price of approximately £5,000 and the provision of a confidential discount. The cost-effectiveness regulator stated that there is insufficient evidence to directly compare Aimovig with other preventive migraine treatments, including Allergan’s Botox (onabotulinumtoxinA), which was approved by the US FDA in 2010 for the treatment of chronic migraine and subsequently recommended by NICE. Although Aimovig, as a once-monthly self-injected therapy, offers greater convenience compared with the multiple injections required for Botox, NICE still requires Novartis to provide additional clinical evidence for Aimovig.

The Institute for Clinical and Economic Review previously concluded that Aimovig is cost-effective, but should only be used after patients have tried existing preventive treatments without success. NICE also noted that the data does not adequately cover relevant patients within the NHS system, and the long-term efficacy for populations with chronic migraine and episodic migraine remains unclear.

Aimovig does not enable the effective use of NHS resources, but this does not mean that the collaboration between Aimovig and NICE has ended. Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, stated in a press release, “We will continue to work with the company to ensure there are future opportunities to address the issues highlighted in these interim recommendations.”

Nevertheless, this is undoubtedly a setback for Aimovig, as the drug strives to maintain its lead over Teva’s Ajovy and Lilly’s Emgality. Furthermore, the CGRP market, currently dominated by three major players, appears poised to welcome a fourth entrant, with eptinezumab having submitted its marketing application in the United States this February. Despite this, Leerink analyst Geoffrey Porges remains optimistic about Aimovig’s future, predicting that Aimovig will lead the CGRP market, which is projected to reach $6.9 billion by 2025.

Reference source: Novartis’ Aimovig fails to win NICE backing amid tight migraine fight with Lilly, Teva