‘Life-changing’ migraine drug rejected for NHS use

A migraine drug described as “life changing” by some patients has been rejected for use on the NHS outside of Scotland.

Erenumab, also known by the name Aimovig, was approved for use in Europe last year and is the first treatment designed specifically to prevent migraines.

But on Wednesday the National Institute for Health and Care Excellence (NICE) confirmed a decision to reject the drug on the grounds that it was not cost-effective, citing concerns that the type of patients used in clinical trials did not fully reflect those seen in the NHS.

Warning the decision could “deepen health inequalities”, the Migraine Trust’s chief executive Gus Baldwin said: “NICE has an extremely difficult job but this still feels like a very bad day for chronic migraine patients.

“My main worry is that I’m yet to find a neurologist who doesn’t want to have the option of being able to prescribe these new types of preventive drugs when they and their patient think it is likely to be in the patient’s best interest.

“Crucially, these new drugs do not have the nasty side-effects of other preventives already available.”

Erenumab is the first treatment to target the process that leads to migraine symptoms, using a method described as “one of the most important advances in migraine therapy in decades”.

It uses an antibody consisting of identical cloned immune cells to block the calcitonin gene-related peptide receptor (CGRP-R), which causes blood vessels in the brain to swell.

Current medications for preventing migraine include beta-blockers, antidepressants and epilepsy drugs. If chronic migraine sufferers do not respond to at least three preventive drug treatments, Botox is usually offered.

NICE looked at Erenumab for preventing chronic and episodic migraine in adults who have four migraines a month or more.

Following on from a draft recommendation to reject the drug in January, it cited concerns that clinical trials of Erenumab excluded people for whom all previous treatments had no therapeutic benefit, reasoning that “this group were likely to represent the people most in need of treatment and were therefore the most clinically important subgroup”.

NICE also said it was unclear whether Erenumab works in the long-term and there was no direct evidence from manufacturer Novartis comparing Erenumab with Botox. It concluded there was “a high degree of uncertainty as to whether Erenumab is more clinically effective” than Botox.

Haseeb Ahmad, UK managing director of Novartis, said the firm was “very disappointed” by the move, saying the company had worked closely with NICE to address the issues raised in the January recommendation.

“This decision is particularly disappointing given NICE has recognised the clinical effectiveness and tolerability of Aimovig in chronic migraine, and there remains an unmet need for effective and well-tolerated preventive migraine treatments in the UK,” Mr Ahmad said.

Unlike Botox, the drug can be injected at home and does not require repeated clinic visits or multiple injections into the head and neck, he said.

“Furthermore, treatment with Botox may not be appropriate for everyone that lives with the devastating impact of chronic migraine,” he said.

“We believe in the benefits that Aimovig offers, and we appreciate how disappointing this news will be for those who have waited many years for a targeted preventive treatment to be made widely available.”

Mr Baldwin of the Migraine Trust said he was concerned about the growing post code lottery experienced by migraine sufferers.

“Those who can afford to pay will continue to receive drugs like these while those who can’t will be denied the option.

“Scottish chronic migraine patients can be prescribed this new drug through the Scottish NHS while today’s announcement means that English patients will not be able to access them.

“Far too many people with chronic migraine are having their lives ruined by this horrible brain disease and access to the most effective treatments should not be decided by where you live in the UK.”

Additional reporting by PA