UK approves Lilly's Alzheimer's drug, but deemed 'too expensive' for wide use
Adds Lilly's statement in paragraph 6 and background on EU decision in paragraph 10
Oct 23 (Reuters) -Eli Lilly's LLY.N treatment for early Alzheimer's was deemed too expensive for wide use by UK's cost-effectiveness body on Wednesday, signalling that patients are unlikely to get access following approval by the country's medicines regulator.
The UK's Medicines and Healthcare products Regulatory Agency approved donanemab, branded as Kisunla, making it the second treatment for Alzheimer's in the country after Leqembi, which has been developed by Eisai 4523.T and Biogen BIIB.O.
While Lilly did not provide details on pricing in the UK, the drug costs about $32,000 for a 12-month treatment period in the U.S.
In a draft guidance published simultaneously, the National Institute for Health and Care Excellence (NICE) said donanemab's benefit was "just not enough... to justify the additional cost to the NHS."
NICE is Britain's agency that determines the cost-effectiveness of treatments paid for out of public funds and if they should be used in the state-run National Health Service (NHS).
Lilly said it remains confident in the cost-effectiveness of donanemab and will work closely with NICE during the consultation period, which ends on Nov. 20.
Donanemab, given as an infusion every four weeks, has shown to slow down cognitive decline by four to seven months in clinical studies. The cost-effectiveness estimate for donanemab is five to six times above what NICE normally considers an acceptable use of NHS resources, it said.
"There are significant uncertainties about how much benefit donanemab provides, and how long this lasts for after stopping treatment," NICE said.
NICE had also deemed Leqembi too expensive in its draft guidance in August. Both treatments require careful monitoring of patients, it said. Leqembi costs $26,500 annually in the U.S.
Lilly's drug is also under review by the European health regulators, which rejected Leqembi earlier this year.
It is estimated that around 70,000 adults in England would have been eligible for treatment with donanemab, according to NICE.
Reporting by Prerna Bedi, Shanima A, Bhanvi Satija and Mariam Sunny in Bengaluru; Additional reporting by Angela Christy; Editing by Sherry Jacob-Phillips, Varun H K and Shreya Biswas
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