The UK’s National Institute for Health and Care Excellence (NICE) has published the final draft guidance for Novartis’ Aimovig (erenumab), rejecting the migraine drug for National Health Service (NHS) funding.

The draft guidance reviewed erenumab to prevent chronic and episodic migraine in adults having four or more migraine episodes each month and inadequate response to at least three other preventive therapies.

Aimovig, which can be self-administered at home, works by targeting the process whereby proteins cause swelling of blood vessels in the brain.

The list price of the drug is approximately £5,000 per patient per year; NICE said that the price would not be a cost-effective use of NHS resources.

The final decision comes after an analysis of a revised commercial arrangement proposed by Novartis following the initial rejection in NICE’s draft guidance.

While NICE notes that the drug is clinically effective compared to best supportive care, concerns were raised about the lack of clinical trial inclusion of patients where other preventive treatments did not work.

Novartis submitted additional data on the long-term effectiveness of the drug. NICE noted that this data from episodic migraine patients did not specify the number of previous treatment failures.

Based on the evidence, Aimovig’s long term effectiveness remains unclear.

Furthermore, the company failed to provide direct evidence comparing Aimovig with NICE-approved botulinum toxin type A made for chronic migraine.

A statement from NICE read: “The company did not submit an updated cost-effectiveness analysis for episodic migraine. Because of these factors and after considering the proposed new commercial arrangement, the cost-effectiveness estimates for erenumab remain higher than what NICE usually considers to be acceptable.”

Novartis state, in response to the decision, that the company will continue to explore other options to provide access to the drug in the future.

Novartis Pharmaceuticals managing director UK, Ireland and Nordics Haseeb Ahmad said: “This decision is particularly disappointing given NICE has recognised the clinical-effectiveness and tolerability of Aimovig in chronic migraine and there remains an unmet need for effective and well-tolerated preventive migraine treatments in the UK.”