Alzheimer’s Drug Donanemab Does Not Currently Demonstrate Value For The NHS says NICE
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 says the National Institute for Health and Care Excellence (NICE).
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).
Helen Knight, director of medicines evaluation at NICE said:
“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.”
“NICE independent committee looked at all the available evidence, including the benefits for carers, which revealed that donanemab could slow down cognitive decline by 4-7 months, but this is just not they say 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.”
Professor Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society, said:
“Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia. MHRA’s approval of donanemab marks another milestone in this journey, but it comes alongside a draft NICE decision not to recommend donanemab for use on the NHS. While this is disheartening, we respect the decision of the regulator.”
“In other diseases like cancer, treatments have become more effective, safer and cheaper over time and we hope to see similar progress in dementia.”
“With around 20 Alzheimer’s disease drugs in late-stage clinical trials, more drugs will be submitted for approval within the next few years.”
“New treatments are an important catalyst for change, but they are only one piece of the puzzle. While preparing for the future, we must not lose sight of the million people living with dementia in the UK today – a third of whom don’t have a diagnosis.”
“We need to see significant government investment to bring about radical change so that everyone with dementia in the UK can get an early and accurate diagnosis. Without this, people won’t be able to access existing treatments and interventions to help manage their symptoms today or be ready for the disease slowing treatments of tomorrow.”