NICE rejects Novartis' Aimovig on data 'uncertainty' despite migraine benefits

Amgen and Novartis teamed up in 2015 to collaborate on migraine and Alzheimer's drug candidates. (Amgen)

England's cost watchdogs admit that migraine sufferers have a shortage of options and must deal with waiting lines for Allergan's Botox—and that in some parts of the country, it isn't even available. But they still refused to back Novartis' new alternative, Aimovig.

In a final appraisal, the National Institute of Health and Care Excellence (NICE) ruled that data supporting the CGRP drug are insufficient to issue a positive recommendation. Currently, migraine sufferers try at least three oral preventative drugs before doctors recommend a specialized treatment such as Aimovig or Allergan’s Botox. 

In particular, the data comparing Aimovig to Botox aren't strong enough to warrant extra spending on the new drug, the agency said. That comes despite a convenience advantage for Aimovig, Novartis said. Botox requires multiple injections into the head and neck by a healthcare professional, while Aimovig can be self-administered at home once a month, eliminating the need for numerous doctor visits. 

NICE also recognized that there are already long waiting lines for Botox and that the drug isn’t available everywhere in the country. And as for oral options, patient experts told agency officials the drugs come with “significant side effects, can be poorly tolerated and may not work for some people,” according to the appraisal document. 

Haseeb Ahmad, Novartis' president in the U.K., said in a statement that the company is "very disappointed" and that the rejection is "not the result we’ve been working toward." The company has a "track record of going above and beyond when it comes to working with reimbursement agencies and we understand the need for companies to be flexible in order to make new medicines readily available," he added.

Novartis offered a price break on Aimovig, but NICE couldn't look past "uncertainty in the evidence," Ahmad said. The decision is "particularly disappointing" considering Aimovig's recognized benefits and the unmet need for migraine sufferers, the Novartis exec added. 

RELATED: Novartis’ Aimovig fails to win NICE backing amid tight migraine fight with Lilly, Teva 

Aimovig won European approval last year to prevent migraines for patients who suffer at least four of the headaches per month. Earlier this year, NICE rejected the drug on a preliminary basis, prompting a surge of comments that forced the agency to delay the final report, pharmaphorum reports

David Bloomfield, CEO of London’s National Migraine Center, said in a statement that the group is “saddened” about the latest decision. 

“Current treatment options are not universally useful and this decision removes both hope and options for those people unable to find relief using current treatments,” he said. He said he hopes officials will revisit the decision down the road. 

With the decision, migraine sufferers will have to get by with existing options and await NICE’s rulings on Aimovig's CGRP rivals, which are Emgality from Eli Lilly and Ajovy from Teva. NICE is set to rule on Ajovy in early 2020 and start its review of Emgality in November. Patients in Scotland already have access to Novartis' Aimovig under an April decision by the Scottish Medicines Consortium.