Eli Lilly announced today that donanemab has received marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease.
Although British regulators declared the drug safe for use, rumors swirled that the National Institute for Health and Care Excellence (NICE), which determines drug availability on the NHS, would deem it too expensive for patients, according to a report from The Telegraph. And today, Lilly's announcement came on the heels of another report by the publication, confirming that Britain's National Health Service (NHS) will block donanemab due to its high cost.
NICE stated that the drug does not currently offer sufficient value for the NHS, citing the need for more evidence on its clinical and cost-effectiveness in treating mild Alzheimer’s.
Although it is estimated that 70,000 adults in England would have been eligible for treatment, the director of medicines evaluation at NICE, Helen Knight, said, "The cost-effectiveness estimate for donanemab is 5 to 6 times above what NICE normally considers an acceptable use of NHS resources." Knight also noted that despite an independent committee reviewing all available evidence, the drug's ability to slow cognitive decline by 4-7 months "is just not enough benefit to justify the additional cost to the NHS."