The National Institute for Health and Care Excellence (NICE) has once again sparked controversy and debate amongst healthcare institutions after it rejected a “life-changing” migraine drug for use in the NHS in England.
Erenumab, also known as Aimovig, was first rejected by NICE in draft guidance in January, but it has now been eliminated from the final document, meaning people in England cannot have access to the drug on the NHS.
Erenumab is approved for use in Europe and Scotland. However, NICE said the decision was based on data which it felt was not sufficient proof of efficacy over Botox, which is available on the NHS.
NICE was also concerned that the clinical trials conducted by the manufacturer Novartis were not entirely accurate. They excluded people for whom all previous treatments had no therapeutic benefit.
In a statement, it said, “This group were likely to represent the people most in need of treatment and were, therefore, the most clinically important subgroup”.
Pharmaceutical company Novartis said it was “very disappointed” by the move.
Novartis UK Managing Director Haseeb Ahmad said the decision was “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”.
Dr Katy Munro, headache specialist doctor and member of the National Migraine Centre, shares the same disappointment regarding NICE’s decision.
She said NICE did not take into account the fact that several patients with chronic migraine had tried and failed all the afore-mentioned treatments, but once they have been treated with Aimovig, the responses were mainly positive.
Dr Munro added: “For patients with chronic migraine, a reduction in pain score, even if not aborting the migraine completely, can make the difference between a day they can function and a day their attack totally debilitates them. We feel this was not given enough consideration.”
The challenges faced by patients with chronic migraine go much further than just physical debilitation. There are more challenges once migraine patients ask for help. Dr Munro mentioned the widespread misunderstanding of migraine as “just a bad headache” as one of the key obstacles, combined with poor medical knowledge on migraines.
She said once patients managed to see a GP, many of them only had a basic understanding of chronic migraine and how best to help sufferers and along with that, GPs only have 10 minutes allocated to an appointment.
“This is, in my opinion, insufficient to explore the story, inform the patient about possible treatment options and work out a plan together,” said Dr Munro.
“I think resources in the NHS are stretched incredibly thinly and there is a huge need for more to be done to help migraine sufferers access good quality care. Training and resources need to go hand in hand. Further training for doctors is essential.”
On the other hand, GP and member of the Kent Local Medical Committee, Dr Julian Spinks, said that NICE was not the only one to blame.
He said some of the blame must lie with the manufacturer who could not come up with the evidence that NICE needed to prove it was worthwhile to approve it.
“It is very expensive, so NICE would normally approve for people who have failed other treatments. Unfortunately, the research provided excluded those patients. One problem is that NICE does not accept anecdotes, so patients and doctors who say ‘I tried it and it works’ would not contribute to the decision”, said Dr Spinks.
The GP does agree that more needs to be done to address migraine patients’ needs and improve their quality of life.
He said the degree of support provided by the NHS varies as it depends on the GP practice and available specialist service. The problem is, however, when patients fail standard treatment.
He said, “We have very few neurologists compared with other European countries and the wait for specialist appointments can be really long.
“We need to empower patients by helping them to understand the condition and how to manage it”.
Very interesting and informative! Congrats!