The NHS spending watchdog has recommended that a ‘groundbreaking’ Alzheimer’s drug shouldn’t be made available on the NHS.
It comes just days after experts in the UK hailed it as the ‘beginning of the end’ for the devastating disease.
The National Institute for Health and Care Excellence (Nice) have now said the benefits of lecanemab are ‘just too small to justify the significant cost to the NHS.’
The drug was deemed efficient at slowing Alzheimer’s disease by the The Medicines and Healthcare products Regulatory Agency (MHRA) earlier this week.
The targeted antibody treatment binds to amyloid, a protein which builds up in the brains of people living with the condition.
It is designed to help clear the build-up and slow down cognitive decline and is given to patients through an intravenous drip fortnightly.
The drug is the first treatment of its kind to be licensed for use in Great Britain.
A charity said it is ‘deeply disappointing’ patients with early stage Alzheimer’s will not have access to the drug on the health service ‘and it will only be available to those who can pay privately.’
Alzheimer’s Research UK has urged Health Secretary Wes Streeting to step in.
In a letter, they wrote: ‘We know that right now, one in three people in England aren’t receiving a formal diagnosis and there are considerable waiting lists to receive a dementia diagnosis with people waiting up to a year. Action from government is essential to address these challenges.
‘On behalf of our supporters, Alzheimer’s Research UK are calling on you to help the NHS be fit for the future of dementia. Your leadership in bringing together key stakeholders is needed to help enable fast and equitable access to a new generation of treatments.’
A Department of Health and Social Care spokesperson said: ‘It is right that these decisions are taken independently based on an assessment of the available evidence on the relative costs and benefits of a treatment… We will continue to work with NHS England and NICE to make treatments available as and when they’re ready.’
All you need to know about Lecanemab
What is Lecanemab?
- Lecanemab is an antibody drug that has been shown to slow down the early stages of Alzheimer’s. It works by binding to a protein known as amyloid, which builds up in the brains of people living with the disease.
How effective is the drug?
- Lecanemab been shown to successfully remove amyloid build-up from the brains of people living with early Alzheimer’s disease.
- For people taking the drug, 18 month-long trials showed the decline in thinking and memory skills slowed down by 27%.
It also slowed down the decline in quality of life by up to 56%.
How is the drug given?
- Lecanemab is given every two weeks through an intravenous (IV) drip.
Are there any side-effects?
- During clinical trials, some people taking lecanemab experienced reactions to having the drug infused, fever, rash, chills and body aches, while some others were found to have swelling or microbleeds in the brain in response to the drug.
- There have also been three deaths related taking lecaneamb in the trial, but this is less than 0.2% of patients taking part.
- The majority of people who experienced brain bleeding or swelling had no symptoms and these changes were only detected using brain scans.
Are other countries using the drug?
- Lecanemab has already been approved in the US, Japan and China.
Dr Samantha Roberts, chief executive of Nice, said: ‘This is a new and emerging field of medicine which will no doubt develop rapidly. However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS.
‘It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side-effects, plus the cost of purchasing the drug.
‘Our independent committee has rigorously evaluated the available evidence, including the benefit for carers, but Nice must only recommend treatments that offer good value to the taxpayer.’
According to Nice, clinical trials showed lecanemab can slow cognitive decline by four to six months, however there is little evidence on its long-term effects.
It estimates about 70,000 adults in England would have been eligible for treatment.
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: ‘Today’s news is bittersweet for people affected by Alzheimer’s disease.
‘It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms.
‘However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs. It means that, as things stand, people in the early stages of the disease will be denied access to lecanemab through the NHS, and it will only be available to those who can pay privately. This is deeply disappointing.’
Lecanemab is already licensed in the US, where it costs about £20,000 per patient per year, although it was rejected by the European Medicines Agency (EMA) in late July.
The EMA said the benefits of lecanemab did not counterbalance the risk of people suffering serious side-effects such as bleeding and swelling in the brain.
It also said the effects of the drug on delaying cognitive decline were small.
A similar drug called donanemab, which is developed by Eli Lilly, is also being assessed for approval in the UK by medicine regulators.
NHS England estimates between 50,000 and 280,000 patients might be eligible for the new treatments.
Get in touch with our news team by emailing us at webnews@metro.co.uk.
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