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NICE delivers final ‘no’ for Novartis’ migraine treatment Aimovig

Blow to patients who have dubbed the treatment 'life-saving'

Aimovig

Novartis has been delivered another ‘no’ for its migraine prevention drug Aimovig (erenumab) from NICE, following draft guidance which rejected the drug earlier this year.

The final appraisal has confirmed that the original decision remains unchanged, with NICE saying that a lack of significant data meant it could not recommend the treatment for routine use on the NHS.

In a statement, NICE said that the trials of Aimovig “excluded people for whom all previous treatments had no therapeutic benefit”. This significant patient population, the cost-effectiveness agency says, represents those who would be most in need of the treatment and the “most clinically important subgroup”.

It also said that the long-term data which Novartis provided did not show that Aimovig had a clear sustained benefit, and that it only included people with episodic migraine and did not specify how many previous treatment they had failed before taking the drug.

The agency also presented concerns that for the chronic migraine subgroup, there was no direct comparison with the current standard of treatment, botulinum toxin type A (Botox), so its superiority is uncertain.

Ultimately, NICE deemed that the cost-effective estimates for the drug are higher than what it deems to be acceptable. Aimovig has a list price of £5,000 per year, although Novartis would have offered NICE a confidential discount. It seems that even with such a discount, the watchdog still does not think it is worth the money based on the data Novartis supplied.

The decision comes as a blow to Novartis, who have said that Aimovig has significant benefits over the current standard of treatment, including its self-administering dosing which means patients do not have to repeatedly attend clinic appointments.

“We’re very disappointed that NICE has not recommended Aimovig for use on the NHS. Clearly this is not the result we’ve been working towards; with chronic migraine patients in England who could benefit from Aimovig being denied routine access to this important treatment option, whilst it is NHS funded in Scotland,” said Haseeb Ahmad (pictured below), managing director UK, Ireland and Nordics and Novartis president UK.

ahmad

Haseeb Ahmad

The preventative medicine is available for use in on the NHS in Scotland – this rejection has been criticised for establishing a post-code lottery of access, with those who cannot afford the medicine cut-off from the potential benefits of the drug.

“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,” Ahmad added.

The frustration from patients is also profound, with many suffering from migraines describing the drug as ‘life-changing’.

Responding to the news of the rejection, chief executive of The Migraine Trust Gus Baldwin said that it is a “very bad day for chronic migraine patients”.

“My main worry is that I’m yet to find a neurologist who doesn’t want to have the option of being able to prescribe these new types of preventive drugs when they and their patient think it is likely to be in the patient’s best interest. Crucially, these new drugs do not have the nasty side-effects of other preventives already available,” he said.

Since being approved by the European Commission in 2018, Novartis has seen rivals emerge from Eli Lilly (Emgality) and Teva (Ajovy) introduced to the market.

However, Aimovig has established itself as market lead, with Evaluate Pharma estimating sales of $2.05bn in 2024. It also predicts Emgality could hit $1.2bn by this time, with Ajovy forecast to reach $962m.

Article by
Lucy Parsons

26th September 2019

From: Regulatory

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