Novartis knocked back by UK on first-in-class migraine treatment

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(Image: Getty/Tero Vesalainen) (Getty Images/iStockphoto)

Novartis' treatment for migraines is rejected by NICE on cost-effectiveness grounds, and lack of long-term data.

In a draft guidance, the UK’s National Institute for Health and Care Excellence (NICE) rejected the funding of Novartis’ treatment for migraines, Aimovig (erenumab).

Aimovig is a first-in-class monoclonal antibody, specifically designed to prevent migraines. The European Commission approved the treatment, in August 2018, for patients who experience at least four migraine days per month.

In a statement, Haseeb Ahmad, president of Novartis UK, said: “NICE has recognised the clinical-effectiveness of Aimovig and that a significant unmet treatment need exists for people living with migraine in the UK.

He continued, “Our priority now is to continue working closely with NICE to address any outstanding questions they have in order to secure access to this innovative treatment for anyone that could benefit from Aimovig, as quickly as possible.”

Aimovig has a UK list price of £386.50 ($493) per 70mg or 140mg dose, with the recommended dosing interval being every four weeks.

Explaining its decision in not recommending the treatment, NICE stated, “the committee concluded that the incremental cost-effectiveness ratio (ICER) for erenumab was likely to be higher than around £20,000 per quality-adjusted life year (QALY).”

Alongside this finding, NICE noted, “there was no evidence that comparative efficacy was maintained, and that the long-term evidence was limited because it did not go beyond about a year.”

The guidance is at the draft stage and will be open for further consultation until January 31 of this month.

With rival treatments from Eli Lilly and Teva waiting in the wings, further delays for Novartis could mean competition for Aimovig when it becomes established on the UK market.

All three treatments are already approved in the US, where Novartis made use of its first-to-market advantage by offering free monthly trials of the product to establish its presence prior to rival product’s entry.