The UK medicines regulator has approved a new treatment that can slow Alzheimer’s disease progression, but NICE has said it is too costly for the NHS.

Donanemab, produced by Eli Lilly, is used to treat mild cognitive impairment or mild dementia via a monthly infusion and it requires ‘intensive monitoring for serious side effects’.

NICE has published draft guidance this week which does not recommend donanemab for use on the NHS in England as ‘the benefits it offers patients are too small to justify the additional costs’.

It comes on the same day as donanemab was awarded a licence by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults in the early stages of Alzheimer’s disease who are apolipoprotein E ε4 heterozygotes or non-carriers.

The NICE committee reviewing the medicine said ‘more evidence is needed’ on its clinical and cost effectiveness, and has asked Eli Lilly to address ‘areas of uncertainty’ in the evidence.

NHS England had advised the committee that introducing treatments such as donanemab ‘would substantially increase demand on primary care and memory clinics because of increased awareness of mild cognitive impairment and availability of treatment options’.

This ‘significant increase’ in demand on primary care was listed by NICE as one of the ‘potential uncaptured costs of harms’ of the new treatment.

Around 70,000 adults in England would have been eligible for donanemab, and NICE recognised that their guidance will be ‘disappointing news’.

In August, a similar treatment for mild Alzheimer’s – lecanemab – also received a marketing authorisation from the MHRA but was found to be too costly by NICE.

NICE said that the cost to the NHS of providing donanemab was balanced against the ‘relatively small benefit’ to patients, and this meant it ‘cannot currently be considered good value for the taxpayer’.

Despite clinical trial evidence which showed that the monthly injection can slow the progression of Alzheimer’s by four to seven months, there was also evidence of ‘significant health risks’ associated with the treatment.

The clinical trial showed that a third of those receiving donanemab experienced amyloid-related imaging abnormalities (ARIA) caused by brain swelling and bleeding.

NICE director of medicines evaluation Helen Knight said the treatment’s ability to slow the disease is ‘just not enough benefit to justify the additional cost to the NHS’.

She continued: ‘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.’

Eli Lilly said it will continue to work closely with NICE during the consultation on the draft guidance, which will run until 20 November.

Lilly’s UK president and general manager Chris Stokes said donanemab has ‘demonstrated meaningful results’ and the marketing authorisation today follows ‘more than 35 years of commitment to scientific progress in Alzheimer’s disease’.

‘Early diagnosis remains key to ensuring rapid and equitable access to new innovations, and we are proud to be working with relevant stakeholders to progress this,’ he added.

Professor Tara Spires-Jones, director of the centre for discovery brain sciences at the University of Edinburgh and group leader in the UK Dementia Research Institute, said NICE’s decision will ‘undoubtedly be disappointing’ for people living with dementia.

But she said new treatments such as donanemab are ‘hopeful’ and that ‘new research is bringing us closer to treatments that should be safer and more effective’.

Professor Spires-Jones continued: ‘This decision on the amyloid targeting drug donanemab is not a surprise as it is consistent with the recent recommendations for lecanemab, a very similar drug.

‘Donanemab is an antibody that removes amyloid pathology from the brain. This is not a cure. The treatment slows disease progression modestly but does not stop or reverse symptoms.’

NICE said in its statement on Wednesday that it has identified around 27 products for diagnosing and treating dementia that it expects to be asked to evaluate over the next few years.

A version of this article first appeared in our sister title, Pulse.