The UK medicines regulator has approved lecanemab – the first drug shown to slow cognitive decline in patients in the early stages of Alzheimer’s – but NICE said it was too costly for the NHS.
NICE’s draft guidance, published today, has been put out for a four-week consultation after the committee concluded the benefits of the drug were too small to justify the cost.
It comes on the same day as lecanemab was awarded a license by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 gene (ApoE4).
Charities said the decision was ‘disappointing’ and that NICE had not taken into account the wider potential economic benefits of the drug.
But the Alzheimer’s Society added this was a fast-paced field with more evidence emerging on who would most benefit from disease-modifying treatments and what changes would be needed in the NHS in order to deliver drugs coming through the pipeline.
It is estimated around 70,000 adults in England would have been eligible for treatment with lecanemab had it been approved.
NICE said evidence suggests that people having lecanemab (Leqembi, made by Eisai) in addition to regular treatment continue to have worsening cognitive function over time, but at a slower rate than people on placebo.
The clinical trial showed the progression of the disease was slowed by between four and six months. So far data has only been reported up to 18 months.
More evidence is needed on the long-term effects and there are also ‘substantial uncertainties’ around infusion costs and monitoring needs, the committee said.
While the drug itself is expensive, at around £20,000 a year based on the US price, the cost is a more complex issue because of the need for fortnightly infusions and close monitoring.
NICE has asked the company and NHS England to provide more information to address these issues.
But regardless it found ‘all of the cost-effectiveness results seen by the committee are considerably above what NICE considers an acceptable use of NHS resources’.
In July, the European Medicines Agency rejected a license for lecanemab because it said serious side effects, including bleeding and swelling in the brain, were not worth the modest benefit. It was approved in the US earlier this year.
Experts had already warned that NHS dementia services were not set up to identify which patients may be eligible for new disease-modifying therapies coming through.
This includes amyloid biomarker testing as well as services to deliver treatments.
NICE said as more data became available on the impact and delivery of newer drugs, they would be able to update their modelling accordingly.
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.’
Helen Knight, director of medicines evaluation at NICE, said: ‘Lecanemab and other similar treatments for Alzheimer’s disease now coming on stream have prompted a great deal of debate about the prospects of being able for the first time to slow the effects of a condition that is progressive, life-limiting, complex and distressing.
‘Lecanemab provides on average 4 to 6 months slowing in the rate of progression from mild to moderate Alzheimer’s disease, but this is just not enough benefit to justify the additional cost to the NHS.’
Alzheimer’s Research UK’s chief executive, Hilary Evans-Newton, described the news as ‘bittersweet’.
‘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,’ she said.
Chief policy and research officer at Alzheimer’s Society, Fiona Carragher, said: ’While we welcome the MHRA approval, it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage.
‘We respect the decisions regulators have made, however we know these announcements will bring a mix of emotions for those who have been waiting a long time since the promising trial results were first announced.
‘The NICE recommendation reflects the urgent challenges which must be addressed regarding how we diagnose and treat people with dementia. A third of people affected by dementia have not received a diagnosis, and for those who have been diagnosed, it’s often not early or accurate enough for a person to be eligible for new treatments.’
Professor Paresh Malhotra, head of the division of neurology at Imperial College London and a consultant neurologist, said the MHRA and NICE’s respective decisions are ‘reflective of the complex issues surrounding the development of these new Alzheimer’s drugs’ including ‘the hope that they bring to the community, but also their cost and relatively modest effects on disease progression as well potential side effects’.
‘Lecanemab does not actually improve patients’ symptoms but appears to reduce the speed of decline and treatment comes with significant potential risks,’ he said.
‘There will be much discussion and controversy about these decisions, but for those of us who see patients with Alzheimer’s disease, it is critical that we get across these complexities as well as the realities of treatment.
‘If patients and families are seeking to be treated privately, it is very important indeed that the risks, potential benefits and implications of treatment (regular intravenous infusions and monitoring scans) are explained carefully, clearly and thoroughly before any treatment decision is made.’
The public consultation on the draft NICE guidance will close on Friday 20 September 2024 with responses to be considered at a second committee meeting later in the year.
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