The U.K.'s National Institute for Health and Care Excellence did not recommend Amgen Inc. and Novartis AG's migraine treatment Aimovig, citing cost concerns.
The drug price watchdog was evaluating Aimovig, or erenumab, for preventing chronic and episodic migraine in adults who have four or more episodes of migraine every month even after undergoing at least three prior treatments.
A migraine is a disabling neurological disease characterized by severe head pain, nausea and vomiting. Patients with episodic migraines have between zero and 14 headache days per month, while chronic migraines are 15 or more headache days per month.
NICE said in a Jan. 10 draft guidance that even though Aimovig was a clinically effective treatment, the trial evidence neither fully reflected patients seen in clinical practice in the U.K.'s National Health Service nor does it include all the relevant comparators and outcomes. The watchdog added that the cost-effectiveness estimates for the drug were higher than acceptable.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE said, "[T]here was not enough evidence to suggest that [Aimovig] is more effective than botulinum toxin type A for people with chronic migraine, which NICE already recommends."
Boysen stated that for patients with chronic and episodic migraine there was no evidence to show that the drug was effective in the long term for those who had not responded to three previous preventive treatments.
The list price for Aimovig is about £5,000 per year but Novartis had agreed to provide the drug at a discount under a confidential commercial arrangement.
NICE said it will work with Novartis to address the issues highlighted in the provisional recommendations. Comments on NICE's draft recommendations will close Jan. 31.
Aimovig, which is a monthly self-administered injection used via Amgen's SureClick autoinjector device, belongs to a group of medicines known as calcitonin gene-related peptide inhibitors that include Eli Lilly and Co.'s Emgality and Teva Pharmaceutical Industries Ltd.'s Ajovy.
Both Emgality and Aimovig were included for 2019 coverage by Express Scripts Holding Co. while Ajovy had missed out.
Novartis and Amgen entered a collaboration in August 2015 to develop and commercialize treatments for migraine and Alzheimer's disease. The collaboration was expanded in April 2017 to include co-commercialization of Aimovig in the U.S.