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…