The clinical trial evidence available shows that the drug is a clinically effective treatment compared with best supportive care.

National Institute of Health and Care Excellence (NICE) on Thursday published its final draft guidance not recommending Novartis’ migraine drug Erenumab (Aimovig).

The drug, which is for preventing chronic and episodic migraine in adults, is not cost-effective, the agency said.

The self-administered injection costs around £5,000 per patient per year at its list price.

The clinical trial evidence available shows that the drug is a clinically effective treatment compared with best supportive care. It targets the process by which proteins cause blood vessels in the brain to swell, leading to the symptoms associated with migraines.

However, the NICE committee is concerned about the long term effectiveness of erenumab even though the company had provided additional evidence. The committee noted that the additional evidence only included people with episodic migraine and did not specify the previous failed treatments before using erenumab.

The committee said people who had unsuccessfully tried other treatments need the treatment most.

“For chronic migraine, there was no direct evidence comparing erenumab with NICE-approved botulinum toxin type A which is considered current practice in the NHS in England. Therefore, the committee reaffirmed its view that there was a high degree of uncertainty as to whether erenumab is more clinically effective than that treatment,” NICE said in a statement.

The agency also found the cost-effectiveness estimates for erenumab higher than the usually acceptable limit.

This is the second time NICE rejecting the drug citing the same reason. Earlier this year, NICE said they will work with the company, but the according to the latest report Novartis has not submitted any updated cost-effective analysis.

Estimates show people experiencing around 190,000 migraine attacks every day in England, with women more likely to experience one than men.

Erenumab is approved by the Scottish Medicines Consortium for use in patients with chronic migraine when all other treatments are failed.

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