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A drug that can slow the debilitating symptoms of Alzheimer’s has been approved by the medicines regulator.

In an unusual double-header assessment by authorities, the Medicines and Healthcare products Regulatory Agency (MHRA) has said the drug lecanemab is safe and effective enough for doctors to prescribe in Britain, but a separate NHS watchdog has ruled that it’s not cost-effective and won’t be available.

The decision by the National Institute for Health and Care Excellence (NICE) means that the first drug to show an effect in Alzheimer’s will only be available privately.

In the US the treatment costs £20,000 a year.

A key clinical trial has shown lecanemab can slow the decline in memory and mental agility by 27% in patients with mild Alzheimer’s.

But it can also cause swelling and bleeding in the brain of some patients.

NICE heard evidence it slows down progression of the disease by between four and six months but concluded that the costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients, means it cannot be considered good value for the taxpayer.

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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.”

The MHRA decision would not apply in Northern Ireland, which has a separate process.

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From November 2022: Inside a lab working on Alzheimer’s treatment

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While US authorities have approved the drug, the EU’s medical regulator rejected a licence because it considered the benefits too small to justify the risks.

According to results of the clinical trial published two years ago, the drug cleared clumps of a protein called amyloid – thought to be a key cause of the most common form of dementia – from patients’ brains.

It removed so much of the amyloid protein that the patients wouldn’t have had enough evidence of Alzheimer’s disease on their brain scans to actually qualify for entry to the trial.

The study strongly suggests the drug only starts to have a clinical effect once amyloid is reduced to low levels in the brain.

Results after 12 months of treatment suggested it was ineffective – but after 18 months, the effect was significant.

Doctors were optimistic at the time that continued treatment would lead to even better results.

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UK on ‘slippery slope’ to ‘death on demand’, Justice Secretary Shabana Mahmood warns ahead of assisted dying vote

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UK on 'slippery slope' to 'death on demand', Justice Secretary Shabana Mahmood warns ahead of assisted dying vote

The UK is on a “slippery slope towards death on demand”, according to the justice secretary ahead of a historic Commons vote on assisted dying.

In a letter to her constituents, Shabana Mahmood said she was “profoundly concerned” about the legislation.

“Sadly, recent scandals – such as Hillsborough, infected blood and the Post Office Horizon – have reminded us that the state and those acting on its behalf are not always benign,” she wrote.

“I have always held the view that, for this reason, the state should serve a clear role. It should protect and preserve life, not take it away.

“The state should never offer death as a service.”

Analysis: Justice secretary’s intervention is potentially embarrassing for the PM

On 29 November, MPs will be asked to consider whether to legalise assisted dying, through Kim Leadbeater’s Terminally Ill Adults (End of Life) Bill.

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Minister ‘leans’ to assisted dying bill

Details of the legislation were published last week, including confirmation the medicine that will end a patient’s life will need to be self-administered and people must be terminally ill and expected to die within six months.

Ms Mahmood, however, said “predictions about life expectancy are often inaccurate”.

“Doctors can only predict a date of death, with any real certainty, in the final days of life,” she said. “The judgment as to who can and cannot be considered for assisted suicide will therefore be subjective and imprecise.”

Read more: Gordon Brown says assisted dying should not be legalised

Under the Labour MP’s proposals, two independent doctors must confirm a patient is eligible for assisted dying and a High Court judge must give their approval.

The bill will also include punishments of up to 14 years in prison for those who break the law, including coercing someone into ending their own life.

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Details of end of life bill released

Read more: Where does the cabinet stand on assisted dying?

However, Ms Mahmood said she was concerned the legislation could “pressure” some into ending their lives.

“It cannot be overstated what a profound shift in our culture assisted suicide will herald,” she wrote.

“In my view, the greatest risk of all is the pressure the elderly, vulnerable, sick or disabled may place upon themselves.”

Kim Leadbeater waits to present the Assisted Dying Bill. File pic: House of Commons/Reuters
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Kim Leadbeater waits to present the Assisted Dying Bill. File pic: House of Commons/Reuters

Labour MP Kim Leadbeater, who put forward the bill, said some of the points Ms Mahmood raised have been answered “in the the thorough drafting and presentation of the bill”.

“The strict eligibility criteria make it very clear that we are only talking about people who are already dying,” she said.

“That is why the bill is called the ‘Terminally Ill Adults (End of Life) Bill’; its scope cannot be changed and clearly does not include any other group of people.

“The bill would give dying people the autonomy, dignity and choice to shorten their death if they wish.”

In response to concerns Ms Mahmood raised about patients being coerced into choosing assisted death, Ms Leadbeater said she has consulted widely with doctors and judges.

“Those I have spoken to tell me that they are well equipped to ask the right questions to detect coercion and to ascertain a person’s genuine wishes. It is an integral part of their work,” she said.

In an increasingly fractious debate around the topic, multiple Labour MPs have voiced their concerns.

In a letter to ministers on 3 October, the Cabinet Secretary Simon Case confirmed “the Prime Minister has decided to set aside collective responsibility on the merits of this bill” and that the government would “therefore remain neutral on the passage of the Bill and on the matter of assisted dying”.

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‘Immediate action’ taken after blueprints of prisons in England and Wales leaked on dark web

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'Immediate action' taken after blueprints of prisons in England and Wales leaked on dark web

“Immediate action” is being taken after blueprints of jail layouts were shared online.

The maps detailing the layouts of prisons in England and Wales were leaked on the dark web over the past fortnight, according to The Times.

The detailed information is said to include the locations of cameras and sensors, prompting fears they could be used to smuggle drugs or weapons into prisons or help inmates plan escapes.

Security officials are now working to identify the source of the leak and who might benefit from the details.

The Ministry of Justice did not disclose which prisons were involved in the breach.

A government spokesperson said in a statement: “We are not going to comment on the specific detail of security matters of this kind, but we are aware of a breach of data to the prison estate and, like with all potential breaches, have taken immediate action to ensure prisons remain secure.”

The leak comes amid a chronic prison overcrowding crisis, which has led to early release schemes and the re-categorising of the security risks of some offenders to ease capacity pressures.

Justice Secretary Shabana Mahmood is launching a sentencing review in a bid to ease the crisis.

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Starmer says UK will ‘set out a path’ to raise defence spending to 2.5% in spring

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Starmer says UK will 'set out a path' to raise defence spending to 2.5% in spring

The UK will “set out a path” to lift defence spending to 2.5% of national income in the spring, the prime minister has said, finally offering a timeframe for an announcement on the long-awaited hike after mounting criticism.

Sir Keir Starmer gave the date during a phone call with Mark Rutte, the secretary general of NATO, in the wake of threats by Moscow to target UK and US military facilities following a decision by London and Washington to let Ukraine fire their missiles inside Russia.

There was no clarity though on when the 2.5% level will be achieved. The UK says it currently spends around 2.3% of GDP on defence.

Volodymyr Zelenskyy, Nato Secretary General Mark Rutte and  Keir Starmer, during a trilateral meeting in 10 Downing Street.
Pic: PA
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Ukraine leader Volodymyr Zelenskyy, Sir Keir Starmer and NATO boss Mark Rutte in October. Pic: PA

Ukraine war latest: Follow live updates

A spokeswoman for Downing Street said that the two men “began by discussing the situation in Ukraine and reiterated the importance of putting the country in the strongest possible position going into the winter”.

They also talked about the deployment of thousands of North Korean soldiers to fight alongside Russia.

“The prime minister underscored the need for all NATO countries to step up in support of our collective defence and updated on the government’s progress on the strategic defence review,” the spokeswoman said.

“His government would set out the path to 2.5% in the spring.”

The defence review will also be published in the spring.

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While a date for an announcement on 2.5% will be welcomed by the Ministry of Defence, analysts have long warned that such an increase is still well below the amount that is needed to rebuild the armed forces after decades of decline to meet growing global threats from Russia, an increasingly assertive China, North Korea and Iran.

They say the UK needs to be aiming to hit at least 3% – probably higher.

With Donald Trump returning to the White House, there will be significantly more pressure on the UK and other European NATO allies to accelerate increases in defence spending.

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