Eli Lilly’s Alzheimer’s drug Kisunla is likely to face an uphill uptake battle in the UK after its local cost-effectiveness watchdog NICE said it “cannot currently be considered good value for the taxpayer.”
The UK medicines authority approved Kisunla on Wednesday, making it the third major market to sign off on the amyloid-targeting medicine.
It’s almost a repeat of the roller coaster that Lilly’s Alzheimer’s competitors Eisai and Biogen experienced with their drug Leqembi in August. Similarly, the UK gave a nod to the duo’s treatment two months ago, but NICE also said it was leaning against reimbursing that drug.
The European Medicines Agency is still reviewing Lilly’s drug. But precedent doesn’t look to be in its favor, with the EMA’s medicines committee rejecting Leqembi in July.
NICE said it believes about 70,000 adults in England would have been eligible to receive Lilly’s monoclonal antibody to treat mild cognitive impairment and mild dementia due to Alzheimer’s.
But the new class of medicines, which are “still in their infancy,” have health risks and “relatively small benefit,” NICE’s independent committee said. About one-third of patients in a clinical trial had signs of brain swelling or brain bleeding, as determined by so-called amyloid-related imagining abnormalities.
Helen Knight“I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed,” Helen Knight, director of medicines evaluation at NICE, said in a statement.
The US first approved Kisunla in July, after two delays that pushed it beyond an original target of late 2023. Japan’s regulators gave a thumbs-up last month.
A 12-month course of Kisunla can cost about $32,000, but not all patients stay on the drug for a whole year since it is meant to be stopped once a certain amount of amyloid plaques are cleared from their brain. Meanwhile, Leqembi’s list price is $26,500 per year and is meant to be a longer-term treatment.
Lilly CEO David Ricks told the UK health secretary last year that Kisunla had “the potential to prevent Alzheimer’s by treating those with a diagnosis before symptoms have developed,” the Financial Times reported earlier this month. The prevention study is not expected to have results until 2027.