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The costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer.
The clinical trial evidence suggests that the monthly injection can slow Alzheimer’s disease progression by 4 to 7 months, NICE’s independent committee heard.
However, there are significant uncertainties about how much benefit donanemab provides, and how long this lasts for after stopping treatment. Further work is also needed to understand the costs of giving the medicine in the NHS.
The committee also heard that clinical trial evidence suggests there are significant health risks associated with the treatment. A third of donanemab recipients experienced amyloid-related imaging abnormalities (ARIA) caused by brain swelling and bleeding.
The committee recognised the importance of new treatment options and has asked the company and NHS England to provide additional information to address areas of uncertainty in the evidence.
Donanemab (also called Kisunla and made by Eli Lilly) has been licensed today by the MHRA for treatment of mild cognitive impairment or mild dementia due to Alzheimer’s disease in some adults. It is a type of drug called a monoclonal antibody, which is given by infusion (through a drip in the arm).
For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers’ money.
Our independent committee looked at all the available evidence, including the benefits for carers. This shows donanemab could slow down cognitive decline by 4-7 months, but this is just not enough benefit to justify the additional cost to the NHS. 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.
It is estimated that around 70,000 adults in England would have been eligible for treatment with donanemab.
NICE is reviewing its guidance on the diagnosis and care of people with dementia to ensure patients get the best care possible while new and emerging medicines are still in their infancy.
NICE has identified around 27 products that it expects to be asked to evaluate over the next few years and is tracking the work of the Blood Biomarker Challenge that is researching whether blood tests are effective in diagnosing different types of dementia.
In August NICE issued draft guidance that did not recommend lecanemab, another monoclonal antibody for mild Alzheimer’s.
Both treatments require careful monitoring in hospital after treatment is given.
Alzheimer’s disease is thought to be caused by the abnormal build-up of proteins in and around brain cells. One of these proteins is called beta-amyloid. Deposits of these amyloid proteins form plaques around brain cells and disrupt neurone function. Donanemab works by targeting and reducing these beta-amyloid proteins.
The consultation on the draft NICE guidance on donanemab will close on 20 November 2024. The independent committee will consider all responses, including any additional analyses, at a second committee meeting before producing its final recommendations.
Dr Kamar Ameen-Ali
Alzheimer's Association