Despite approval from the UK health authority, the UK’s state-run insurer says Alzheimer's drug Leqembi "cannot be considered good value for the taxpayer." The decision is not yet final.
On August 22nd, the UK’s drug regulation agency — UK Medicines and Healthcare products Regulatory Agency — approved Eisai and Biogen’s anti-amyloid drug Leqembi for early stage Alzheimer’s who have zero or one copy of the Alzheimer’s risk gene ApoE4. But, UK patients won’t have an easy time getting access to it, because the agency that covers the cost of drugs in the UK’s socialized healthcare system says the drug “cannot be considered good value for the taxpayer” due to its small therapeutic benefits and big risk for side effects.
Leqembi was approved for treating the early stages of Alzheimer’s disease in the U.S., Japan, South Korea, and China last year. But the European Medicines Agency declined to approve the drug last month. Leqembi has remained controversial since its initial approval, with many clinicians offering conflicting opinions about the drugs safety and effectiveness.
The UK has socialized healthcare and covers drugs for patients. But according to draft guidance by the country’s healthcare regulator, National Institute for Health and Care Excellence, NICE isn’t planning on covering Leqembi because the drug’s treatment benefits to patients are considered too small, and on top of that, NICE says, the long-term impact of the drug is unknown. The drug would cost tens of thousands of pounds per year out of pocket.
“The NICE decision is likely to be disappointing to those affected by Alzheimer’s disease whose hopes may have been elevated by the early promise of amyloid-targeting therapies,” Paul Morgan, the interim director of the UK Dementia Research Institute at Cardiff University said in a comment on the Science Media Center. “However, given the many unanswered questions around patient selection, monitoring, long-term impact and side effects, the ‘wait and see’ approach is understandable.”
The draft guidance also recommends against administering the drug to people who have two copies of the ApoE4 gene.
Drugmakers Eisai and Biogen released a statement saying that they are working with NICE and Scottish health authorities to make Leqembi accessible to people with Alzheimer’s as soon as possible.
NICE’s guidance is not final. The draft guidance is subject to a public comment period, which lasts until Sept. 20, after which point the drug review committee will reconvene and decide whether to stand its ground.
As for future anti-amyloids, rumors are circulating that MHRA does not plan to approve donanemab (recently greenlit by the U.S. FDA and put on the market as Kisunla).
