Home Health Fury as Alzheimer’s drug ‘Wonder’ will ONLY be offered privately in Britain as charities rule drug regulator’s decision will cause ‘uncertainty and confusion’ for up to a million dementia sufferers and their families

Fury as Alzheimer’s drug ‘Wonder’ will ONLY be offered privately in Britain as charities rule drug regulator’s decision will cause ‘uncertainty and confusion’ for up to a million dementia sufferers and their families

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Se ha demostrado que el lecanemab (en la imagen) ralentiza el avance de la enfermedad que destruye la memoria en sus primeras etapas. Hoy ha sido aprobado por el organismo regulador de medicamentos, la Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA, por sus siglas en inglés).

The first drug proven to slow Alzheimer’s disease is being denied to dementia patients unless they pay for a private drug.

Regulators yesterday made two landmark decisions: licensing lecanemab in the UK, but then refusing to give it to NHS patients on cost grounds.

This means those who are eligible in England can only access the drug, which slows cognitive decline by up to six months, if they can afford to pay tens of thousands of pounds a year for private treatment.

Last night, charities warned that the conflicting rulings will cause “uncertainty and confusion” for up to a million dementia sufferers and their families desperate to access treatments.

David Thomas, of Alzheimer’s Research UK, said the decisions meant the “revolutionary” drug would likely be out of reach of “all but the wealthiest individuals”.

Lecanemab (pictured) has been shown to slow the progression of the memory-destroying disease in its early stages. It has been approved today by the drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Alzheimer's disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss.

Alzheimer’s disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss.

He said: ‘There are people who could benefit from this drug on the NHS right now.

It has allowed me to live a full life.

Larry Woelk, 77, with his wife Rita

Larry Woelk, 77, with his wife Rita

Larry Woelk, 77, has been participating in a lecanemab trial since 2020 after being diagnosed with mild cognitive impairment, a condition that can increase the risk of developing dementia.

He has been receiving an intravenous infusion of the drug every two weeks at the Memory Assessment and Research Centre in Southampton.

“When I first went to the trial, my memory was getting worse,” he said.

“Not quickly, but I noticed. But the progression of my symptoms has plateaued.

‘My memory assessments have not changed since I started taking it.’

An MRI scan in 2018 confirmed the retired business executive had mild cognitive impairment (MCI).

His wife, Rita, said: “There has been some deterioration but it has been gradual. He can still live a full life. He can drive, cycle and socialise.

“If there is an authorised medicine that is safe and effective, in the opinion of the regulator, then it should be available to NHS patients, and not just those who can afford to pay.”

He added: “This drug is not a silver bullet, but we should be thinking about how the UK can take advantage of it rather than not providing any access and letting other countries do the legwork – it doesn’t seem right.”

“We have the capacity to provide medicines by infusion on the NHS (this is done in cancer and other disease areas) and we now have the appropriate diagnostics available.”

The annual cost of dementia to the economy is estimated at £42 billion, with lost income and unpaid carer costs dwarfing the costs of treatment. Earlier this year, the Alzheimer’s Society predicted these costs would reach £90 billion over the next 15 years, with families bearing the brunt of providing unpaid care.

But these external costs are not taken into account by regulators, whose role is to assess value for money against other NHS treatments.

The trials found that lecanemab slowed cognitive decline by about a quarter in patients with early Alzheimer’s, leading many to call it a “turning point” in the fight against the disease.

It received the green light from the Medicines and Healthcare Products Regulatory Agency, the body that decides whether a drug works and is safe.

But the National Institute for Health and Care Excellence (Nice) simultaneously announced that the benefits of lecanemab were “too small to justify the significant cost to the NHS”.

Around 70,000 NHS patients in England would have been eligible for it, with an estimated cost of around £30,000 a year per patient to buy and administer it.

But Nice said the cost of biweekly infusions in the hospital, intensive monitoring for rare but serious side effects and the “relatively small benefits it provides to patients” do not offer good value for the taxpayer.

Vanessa Raymont, an honorary consultant psychiatrist at the University of Oxford, said the MHRA’s approval of lecanemab was “groundbreaking”.

He said it was the first drug approved in the UK with “the potential to… have a real impact on the progression of memory decline”.

It is being used in the US and Japan, but the EU regulator has rejected it because of the risk of serious side effects. In their submission to the regulator, the manufacturers presented estimates of the “non-medical” costs of the care.

Around 900,000 Britons are currently thought to have the memory-impairing disorder. But scientists at University College London estimate this figure will rise to 1.7 million within two decades as people live longer. This is a 40% increase on the previous forecast in 2017.

Around 900,000 Britons are currently thought to have the memory-impairing disorder. But scientists at University College London estimate this figure will rise to 1.7 million within two decades as people live longer. This is a 40% increase on the previous forecast in 2017.

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In the UK, the price of the drug has not been publicly announced. In the US, the treatment costs £20,000 a year, but last month the European Medicines Authority (EMA) rejected it due to concerns about its side effects, such as

The price of the drug has not been publicly announced in the UK. In the US, the treatment costs £20,000 a year, but last month the European Medicines Authority (EMA) rejected it due to concerns about side effects such as “swelling” and “possible bleeding in the brain”.

But the Nice committee, according to the Telegraph, excluded the evidence on the grounds that most of the care had been paid for by families or was provided by them without pay.

Mr Thomas, from Alzheimer’s Research, said: “The failure to include the cost of care in the model is fundamentally unfair. The way these assessments are carried out is simply not fit for purpose.”

Nearly a million people in the UK are living with dementia. Experts said that despite yesterday’s setback, “it is a question of when, not if, new treatments will become available” with more than 160 trials underway around the world.

A Department of Health spokesman said: “It is right that these decisions are made independently. The Government is committed to furthering research and innovation in this area.”

Lecanemab: everything you need to know

Lecanemab is a disease-modifying drug, developed to address the causes of Alzheimer’s rather than just relieve the symptoms. The drug is administered through an intravenous infusion every two weeks, either in the hospital or at a specialized infusion center.

How does it work?

It removes a sticky protein from the brain called amyloid, which is believed to cause the progression of Alzheimer’s disease.

Amyloid forms clumps or plaques around neurons (brain cells that transmit information and instructions). This is a type of immunotherapy that works by harnessing the immune system to remove the buildup of amyloid protein.

Who would the medicine help?

Patients must be in the early stages of the disease and, most importantly, have a diagnosis that shows amyloid protein buildup.

Currently, this can only be achieved through PET scans or cerebrospinal fluid analysis.

Those with other types of dementia or advanced stages of Alzheimer’s are unlikely to benefit.

Is it a cure?

No. In fact, many experts call the effects “modest.” A phase 3 clinical trial involving 1,795 people, half of whom were given lecanemab and half of whom were given a dummy drug for 18 months, found that the drug reduced cognitive decline in patients with early Alzheimer’s disease by about a quarter (27 percent).

So why so much enthusiasm?

This is the first drug that has been shown to slow the progression of Alzheimer’s and, therefore, the deterioration of patients. Current drugs are used only to treat the symptoms, rather than addressing one of the underlying causes.

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