NICE turns down Novartis' Aimovig, flagging clinical trial concerns
- The U.K.'s drug pricing watchdog agency has deemed Amgen and Novartis' migraine treatment Aimovig too pricey for national coverage in a draft decision published Thursday.
- The CGRP inhibitor launched in the U.S. last year as a first-in-class medicine, although competition from Eli Lilly and Teva Pharmaceutical followed within months. While Amgen has led stateside commercial strategy, Novartis holds exclusive commercial rights outside the U.S.
- In this preliminary judgment from the U.K.'s National Institute for Health and Care Excellence, or NICE, the reviewing committee focused on trial design, specifically how Aimovig's studies excluded certain patient populations that would likely use the therapy. This, the committee reasoned, brought uncertainty in the clinical evidence and supported the conclusion that the drug is not cost effective.
Unlike most high-profile NICE decisions, this one appeared focused on clinical evidence more than pricing. While Aimovig (erenumab) carries an annual price of roughly £5,000 (about $6,400), NICE stated, it would not have been cost effective even with a confidential price discount offered by Novartis.
Aimovig's pricing initially surprised some on Wall Street for coming in lower than expected, and an influential U.S. drug pricing group determined it came within its cost-effectiveness range.
However, NICE had concerns that Aimovig does not have sufficient clinical evidence for people who did not respond to previous preventive migraine treatments. All four studies analyzed by the committee excluded patients with no therapeutic response to multiple previous treatments, ranging from two to four depending on the trial.
"The committee was concerned that the people excluded from the trials were likely to represent the most in need of treatment and were therefore the most clinically important subgroup," the draft document stated.
Additionally, the reviewers noted another exclusion they found problematic: people with medication overuse in the episodic migraine studies, saying this group is common, and likely to be seen as eligible for treatment with Aimovig.
Finally, reviewers shared reservations on the long-term efficacy of Aimovig. The four trials ran from three to six months, and two open-label extension studies did not go beyond about a year. The committee concluded the CGRP inhibitor's long-term effectiveness was uncertain.
Haseeb Ahmad, managing director of the U.K. and Ireland for Novartis and country president of Novartis U.K., said in an emailed statement to BioPharma Dive the pharma's priority is to work as quickly as possible to address NICE's concerns, adding the committee failed to consider the broader societal impact of untreated migraine.
"If this decision remains unchanged, patients will be denied access to the first licensed treatment specifically designed to prevent migraine in adults," Ahmad said.
The pharma executive also pointed out Aimovig's patient benefits compared to Allergan's Botox (botulinum toxin type A), which was previously recommended by NICE for migraine treatment. Aimovig can be self-administered at home, while Botox requires many injections at a clinic.
But Meindert Boysen, director of NICE's Centre for Health Technology Evaluation, said in a statement that Aimovig did not have enough evidence to suggest it is more effective than Botox for chronic migraine.
NICE will accept comments through the end of January. The next committee meeting is set for Feb. 14.
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