Alzheimer’s drug lecanemab that slows decline given green light in Britain – but won’t be available on NHS
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.
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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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.
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.
Ukraine leader Volodymyr Zelenskyy, Sir Keir Starmer and NATO boss Mark Rutte in October. Pic: PA
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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.
A man has been arrested on suspicion of murder after one man died and another was critically injured in a shooting in Birmingham.
Police were called to Rotton Park Road in Edgbaston, just before 11pm on Friday, to reports that two people had been shot.
One man, in his 20s, was found in a car but was pronounced dead at the scene.
Another man, in his 30s, was found injured at a bus stop, and was taken to hospital where he remains in a critical condition, West Midlands Police added.
Firearms officers arrested a man in his 30s on suspicion of murder just before 12.30am. He remains in custody.
Officers remain on the scene, with road closures in place. The force said reassurance patrols will also be taking place.
Detective Inspector Nick Barnes said: “This is a tragic incident, and we have worked through the night to understand exactly what happened.
“We’ve already made good progress and arrested a suspect, but I still need to hear from anyone who was in the area that we’ve not already spoken to.
“This happened near the busy junction with City Road and it may be that you’ve got dashcam footage or mobile phone footage from the area just before 11pm.
“We really need to hear from you so that we can build as clear a picture as possible of what happened.”
Officers are urging anyone with information to get in contact, with anonymous tips also taken via Crimestoppers.
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