Campaigners today hit back after health chiefs revealed NHS patients with Alzheimer’s would miss out on a ‘breakthrough’ drug proven to tackle the devastating disease.
Experts have long believed donanemab could herald a new era of dementia treatment, after studies showed it slowed the memory-robbing illness in its early stages.
Today it was approved by medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
Yet, in a blow to tens of thousands of Brits, draft guidance by the NHS spending watchdog ruled the benefits of the drug could not justify the roll-out cost.
It means donanemab will only be available to those who could pay privately every year, unless they are part of a clinical trial.
Experts have long believed donanemab could herald a new era of dementia treatment, after studies showed it slowed the memory-robbing illness in its early stages
Alzheimer’s disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss
It is also believed health insurance policies are unlikely to cover costs.
Campaigners and charities today labelled the decision ‘incredibly disappointing’ and warned that ‘the UK is no longer a good place to launch new dementia treatments’.
It is estimated around 70,000 adults in England would have been eligible for donanemab if approved for use on the health service.
It is also the second time a new Alzheimer’s treatment has been rejected by NICE in a matter of months.
In August, it ruled that the benefits of lecanemab — hailed as ‘the beginning of the end’ of dementia last year — ‘are too small’.
Donanemab has been proven to slow progression of the disease by as much as 35 per cent in trials by helping to remove the build up of the harmful protein amyloid in the brains of people with early-stage Alzheimer’s.
Known as an amyloid immunotherapy, it is thought that these proteins interfere with messages sent between different parts of the brain, resulting in the memory and independence robbing symptoms.
Patients received donanemab through a drip in the arm in hospital, every months for 18 months in clinical trials.
But experts said additional monitoring for side effects including brain scans mean additional costs could spiral.
Currently, the only available drugs on the NHS for Alzheimer’s are to treat symptoms.
Helen Knight, director of medicines evaluation at NICE said: ‘For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers’ money.
‘Our independent committee looked at all the available evidence, including the benefits for carers.
‘This shows donanemab could slow down cognitive decline by 4 to 7 months, but this is just not enough benefit to justify the additional cost to the NHS.
‘The cost-effectiveness estimate for donanemab is 5 to 6 times above what NICE normally considers an acceptable use of NHS resources.
‘I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed.’
NICE also said it had identified 27 other drugs which it ‘expects to be asked to evaluate over the next few years’.
The drug has been proven to slow progression of the disease by as much as 35 per cent in trials by helping to remove the build up of the harmful protein amyloid in the brains of people with early-stage Alzheimer’s
Around 900,000 Brits are currently thought to have the memory-robbing disorder. But University College London scientists estimate this will rise to 1.7million within two decades as people live longer. It marks a 40 per cent uptick on the previous forecast in 2017
Charities and campaigners today, however, slammed the ‘frustrating setback’ and warned that ‘the UK is no longer a good place to launch new dementia treatments’.
Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said: ‘Today’s announcement marks another frustrating setback for people affected by Alzheimer’s disease.
‘We finally have two new treatments licensed in Britain for Alzheimer’s.
‘But it’s incredibly disappointing that NHS patients in England and Wales won’t receive them.
‘While these drugs are not cures and come with risk of side effects, trials show they are the first treatments to slow the decline in memory and thinking skills linked to Alzheimer’s, rather than just alleviating symptoms.
‘NICE’s recent interim decisions on lecanemab and donanemab highlight uncertainty about their benefits compared to the significant costs of delivering them in the NHS.
‘Yet dementia remains the UK’s leading cause of death, and without action, an ageing population means more families will be affected, driving up NHS costs through emergency admissions and care.’
NICE also said it had identified 27 other drugs which it ‘expects to be asked to evaluate over the next few years’
She added: ‘NHS England has identified nearly 30 other dementia treatments that could be available by 2030, giving the government and NHS a crucial opportunity to transform how dementia is treated — just as Labour pledged in their manifesto.
‘But we still haven’t heard from Health Secretary Wes Streeting on how he plans to break the deadlock we’re facing, where research is delivering new treatments but they remain out of reach for NHS patients.
‘Today’s decision also risks signalling that the UK is no longer a good place to launch new dementia treatments.’
The UK also hosts just 7 per cent of global dementia trials, she noted.
‘How the government tackles these challenges will show if they’re serious about bringing innovation to the NHS and cutting the red tape that is limiting people’s access to research and innovative medicines,’ she said.
Meanwhile, Professor Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society, said: ‘MHRA’s approval of donanemab marks another milestone in this journey, but it comes alongside a draft NICE decision not to recommend donanemab for use on the NHS.
‘While this is disheartening, we respect the decision of the regulator.’
She added: ‘New treatments are an important catalyst for change, but they are only one piece of the puzzle.
‘While preparing for the future, we must not lose sight of the million people living with dementia in the UK today — a third of whom don’t have a diagnosis.
‘We need to see significant government investment to bring about radical change so that everyone with dementia in the UK can get an early and accurate diagnosis.
‘Without this, people won’t be able to access existing treatments and interventions to help manage their symptoms today or be ready for the disease slowing treatments of tomorrow.’
It comes as, it was revealed in April that around 5,000 Brits could get cheap blood tests to spot Alzheimer’s in efforts to revolutionise ‘shocking’ NHS diagnostic rates.
Under two landmark trials, researchers from Oxford and University College London are set to use tests to detect proteins in the blood linked to the disease.
At the time, researchers said they hoped the ‘groundbreaking’ blood test, which costs around £100, could speed up the process, allowing patients to get treated earlier.
Recent analysis by the Alzheimer’s Society estimates the overall annual cost of the disease is £42billion a year, with families bearing the brunt.
But the growing, ageing population means the charity estimates these costs – which include lost earnings of unpaid carers – are set to soar to £90billion in the next 15 years.
Around 944,000 in the UK are thought to be living with dementia, while the figure is thought to be around 7million in the US.
Alzheimer’s affects around six in 10 people with dementia.
It is thought to be caused by a build-up of amyloid and tau in the brain, which clump together and from plaques and tangles that make it harder for the brain to work properly.
Eventually, the brain struggles to cope with this damage and dementia symptoms develop.
Memory problems, thinking and reasoning difficulties and language problems are common early symptoms of the condition, which then worsen over time.
Dementia are expected to sky-rocket in the coming years, making a cheap screening tool vital to get to grips with the challenge.
Alzheimer’s Research UK analysis found 74,261 people died from dementia in 2022 compared with 69,178 a year earlier, making it the country’s biggest killer.
