The National Institute for Health and Care Excellence has blocked the availability of the Alzheimer’s drug, donanemab, despite the Medicines and Healthcare products Regulatory Agency granting the drug a licence.
The treatment, which is sold as Kisunla by Eli Lilly, made waves last year when research indicated it could slow the progression of Alzheimer’s disease by 35% in the early stages.
More evidence required
Today has seen NICE conclude that the drug does not offer value for the NHS, though, with clinical and cost effectiveness cited as stumbling blocks.
According to NICE, the relatively small benefit the treatment offers in conjunction with the intensive monitoring needed to look for serious side effects and the general costs of providing the drug mean the taxpayer would not get value for money.
NHS England and Eli Lilly have been asked to provide more evidence to address these areas of uncertainty. The cost-effectiveness of donanemab was estimated to be five-to-six times above what NICE would usually consider an acceptable use of NHS resources.
“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,” said Helen Knight, the director medicines evaluation at NICE.
“I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed.”
A setback
The green light from the MHRA means the treatment will be available privately but will not be available through the NHS, unless NICE reverses its draft decision next year which is when a final decision is expected.
Approximately 70,000 people are in line to benefit from the drug if approved for NHS use.
Responding to the news, Alzheimer’s Research UK’s CEO, Hilary Evans-Newton, has said the decision is “another frustrating setback”.
She added: “We’ve written to the Health Secretary again, calling for his leadership to bring together NICE, NHS England and industry so that people with dementia in the UK aren’t left behind.”
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