Regulatory, Setbacks, UK Biotech

NICE rejects Novartis’ migraine drug Aimovig, months after declining to endorse pricey Kymriah for adult use

Novartis $NVS is willing to play ball with UK’s cost-effectiveness watchdog NICE, who rejected their migraine prevention drug in a draft guidance on Thursday, months after declining to endorse the Swiss drugmaker’s cell therapy Kymriah in adult lymphoma patients.

The drug, erenumab, is sold as Aimovig in the United States by Novartis and partner Amgen $AMGN. It forms part of a new crop of biologics targeting the CGRP protein that transmits pain signals into the brain, and is considered instrumental in generating and maintaining headaches associated with migraine. Erenumab costs around £5,000 (about $6368) per year, excluding a confidential discount that would have been granted to England’s national health service (NHS) had NICE recommended the drug.

In its report, NICE acknowledged that although the drug is a clinically effective treatment, the totality of the data supporting the medicine did not include all “relevant” comparisons against existing drugs and outcomes, which prompted its rejection for NHS use.

Meindert Boysen

“There was not enough evidence to suggest that it (erenumab) is more effective than botulinum toxin type A (Allergan’s Botox) for people with chronic migraine, which NICE already recommends. And for both the chronic and episodic migraine populations there was no evidence to show that erenumab is effective in the long-term in people for whom 3 previous preventive treatments had failed,” said NICE’s director of the centre for health technology evaluation Meindert Boysen in a statement.

Novartis pledged to work with NICE to address the agency’s questions, but suggested the watchdog had not captured the broader societal impact of its medicine.

“NICE does not consider the impact of diseases on broader society when evaluating the cost-effectiveness of medicines. We believe this fails to capture the true value of medicines like Aimovig. As migraine predominantly affects people of working age, it costs the UK economy £8.8 billion per year in lost productivity alone,” the drugmaker said in a statement, underscoring that the UK already “lags significantly behind” its other European counterparts in ensuring access to new medicines.

It is estimated there are 190,000 migraine attacks experienced every day in England, according to NICE. The agency conceded that existing migraine treatments including beta-blockers, antidepressants and epilepsy medicines can have significant side-effects and don’t work for some patients, but for those with chronic migraine for whom at least 3 previous preventive oral treatments have failed, Botox remains an option.

The provisional decision on erenumab comes after the agency refused to endorse Novartis’ CAR-T drug Kymriah in adults, saying it was too expensive, in September, although it did recommend the treatment’s use in pediatric patients in a previous ruling.


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Sr. Manager, Regulatory Affairs, CMC
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