Alzheimer’s ‘marvel’ drug can be blocked by NHS from TODAY

The most effective drug ever for treating Alzheimer’s will today be blocked for use on the NHS.

The Medicines and Healthcare Products Regulatory Agency is expected to declare Donanemab safe for use. 

Donanemab has been described as a game-changer for Alzheimer’s. Research showed it slowed its progression by 35 per cent.

But the National Institute for Health and Care Excellence (Nice) will rule it is too expensive, the Daily Telegraph reported last night.

Under Nice’s guidelines, patients will only be able to obtain either drug from private clinics, unless they are part of a clinical trial, as Health insurance policies are unlikely to cover costs. 

Prof Sir John Hardy, a leading neurological researcher at UCL, said he felt the drug was ‘game-changing’ and that Nice was ‘coming down on the wrong side of the argument’. 

The Medicines and Healthcare Products Regulatory Agency is expected to declare Donanemab safe for use (file image) 

Prof Hardy was the first to identify the role of amyloid in Alzheimer’s, which has now led to drugs that work by clearing the protein. 

He told The Times: ‘These drugs can give people an extra two years at home, rather than in a nursing home. That is time enjoying their lives, having holidays – this is important stuff.

‘These are finely balanced arguments, but I do think they’ve come down on the wrong side of it.

‘I also think that the benefit of approval would be that it would kick NHS dementia care into shape – which really needs to happen. These drugs will come down the line at some point, and I don’t think the NHS is ready for them.’ 

Around 1 million people in the UK are living with dementia, including one in six people over the age of 80, with the vast majority of care is either provided by loved ones or paid for privately. 

However, Nice excludes these ‘non-medical’ costs of care in its decision making. 

According to estimates, the UK spends approximately £42billion a year on dementia, which forecasters says could rise to £90billion by 2040. 

The decision on donanemab is set to mirror one taken in August when lecanemab, the first breakthrough treatment for the condition, was licensed.

Lecanemab manufacturers Lilly estimates the cost of the drug is $32,000 (£24,600) in the US, which is about 25 per cent higher than their original breakthrough drug. 

Donanemab has been described as a game-changer for Alzheimer’s

However, it has the advantage of being a 30-minute monthly intravenous injection, instead of an hour every two weeks, slashing the cost of administering it for the NHS. 

Total treatment costs for donanemab in the US – including monitoring and scans – average $78,000 per year (£60,000) per patient. 

If it adequately clears the amyloid protein in the brain that it targets, patients can stop taking the drug. 

But lecanemab is given indefinitely, until disease reaches a moderate stage. 

Trials also showed donenamab to be more effective than lecanemab because it slowed cognitive decline by 35 per cent, compared with 27 per cent.  

Almost half of participants on donanemab had no clinical progression of disease after a year, compared with 29 per cent on placebo.

Studies also found patients had a higher risk of side effects when taking the drug – with twice as many suffering brain bleeds or swelling . 

Patients will miss out on the best new treatments if the NHS does not fundamentally change the way it calculates the value of drugs, Charities and pharmaceutical companies have claimed. 

In August, Charity Alzheimer’s Research UK wrote to health secretary Wes Streeting to state that he ‘needed to help enable fast and equitable access to a new generation of treatments’.

And this week Chris Stokes, UK general manager of Eli Lilly and Company, which makes donanemab, urged Nice to consider a treatment’s economic and social benefits – such as making it easier for someone to get back to work, or reduce their need for carers.

Mr Stokes told the Sunday Times: ‘If we don’t incorporate the wider value into the discussion, then there is a real risk that patients will miss out on innovative treatment.’