On Wednesday, U.K. regulators approved Eli Lilly And Co’s LLY donanemab, an injection for intravenous infusion to treat mild cognitive impairment and mild dementia due to Alzheimer’s disease.
The infusion, every four weeks, would be available to eligible adults in Great Britain — the third major market to approve donanemab, marketed as Kisunla.
Currently, there are 982,000 people estimated to be living with dementia in the U.K., with 50-75% of cases attributable to Alzheimer’s disease.
It is the leading cause of death in the U.K. and an economic cost to society.
Also Read: Eli Lilly’s Alzheimer’s Drug Raises Hopes but Faces Regulatory Hurdles in Europe.
The total cost of dementia on patients, families and the public sector is estimated to be 42 billion pounds ($54.3 billion) in 2024.
Unpaid care is the largest component, with costs per person increasing threefold from mild to severe dementia.
Last month, The Ministry of Health, Labour and Welfare Japan approved Kisunla for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with mild dementia stage of AD, with confirmed amyloid pathology.
Even though the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Kisunla, the National Institute for Health and Care Excellence (NICE) has refused to cover it.
The costs of providing donanemab balanced against the relatively small benefit cannot currently be considered good value for the taxpayer, the agency ruled.
More evidence is needed on the clinical and cost-effectiveness of donanemab.
Helen Knight, director of medicines evaluation at NICE, said “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.”
Price Action: Eli Lilly stock is down 1.57% at $894.91 at last check Wednesday.
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