When a drug is locked in a tight race with two in-class competitors, earlier patient access matters. But Novartis wasn’t so lucky with its first attempt to get blockbuster hopeful Aimovig onto England's health plan.
The National Institute for Health and Care Excellence (NICE) issued a draft guidance rejecting the Novartis drug for preventing migraine in adults who have at least four migraine days per month. The reason? It wasn’t cost-effective under the authority’s criteria.
Developed by Amgen and sold in Europe by Novartis, Aimovig was the first in the new CGRP class to be approved. But Teva quickly followed with Ajovy and Eli Lilly with Emgality.
NICE is concerned that the data Novartis provided is insufficient to win its recommendation, despite a confidential discount off its list price of around £5,000 a year.
The cost watchdog said there wasn’t enough data comparing Aimovig directly with other preventative migraine treatments, including Allergan’s Botox, which was approved by the FDA to treat chronic migraines in 2010 and later recommended by NICE. Even though Aimovig boasts convenience as a once-monthly, self-injected therapy, compared to Botox’s requirement of several injections by a healthcare practitioner, NICE still wants to see more clinical evidence.
As NICE noted, Novartis used separate clinical studies and indirectly compared the proportion of people on Aimovig with at least a 50% reduction in monthly migraine days at 12 weeks with the proportion of people on Botox that saw their monthly “headache” days slashed by half at 24 weeks.
Separately, the Institute for Clinical and Economic Review previously concluded that Aimovig’s use is cost-effective but only after patients try “existing preventive treatments, which are far less expensive.”
Moreover, NICE also pointed out that the data “doesn’t fully reflect patients seen in clinical practice in the NHS,” and that its long-term effectiveness for both the chronic and episodic migraine populations is as yet unknown.
Due to the “substantial uncertainty” in the evidence, NICE ruled that Aimovig is not a cost-effective use of NHS resources. But that doesn’t mean the end of the road for Aimovig with NICE. The agency often overturns its own decision after considering new data or a bigger discount.
“We will work with the company to ensure that they are given every opportunity to address the issues highlighted in these provisional recommendations,” Meindert Boysen, Pharm.D., director of the Centre for Health Technology Evaluation at NICE, said in a statement.
It’s still a blow for Aimovig as it tries to maximize a head-start advantage over Ajovy and Emgality. Though Novartis and U.S. co-marketer Amgen have expressed enthusiasm over the drug’s early uptake, they have yet to specify how many of the patients are actually getting billed instead of receiving it for free. Leerink analyst Geoffrey Porges has predicted that the total CGRP market will be $6.9 billion in 2025 and that Aimovig will lead the pack.
In Europe, Emgality has already won official European Commission approval. Ajovy’s European nod could also come soon, and NICE is expected to convene a meeting about its coverage June 20.
Editor's Note: This story has been corrected to show that NICE will hold a meeting about Ajovy—not Emgality—June 20.