Despite approval from the UK's regulating agency, patients will have a hard time getting Alzheimer's drug Kisunla. The UK’s state-run insurer says they won't pay for it, mirroring its decision earlier this year on Leqembi.
On October 23nd, the UK’s drug regulation agency — UK Medicines and Healthcare products Regulatory Agency — approved Eli Lilly’s anti-amyloid drug Kisunla for early stage Alzheimer’s in people who have zero or one copy of the Alzheimer’s risk gene ApoE4.
However, UK patients won’t have an easy time getting access, as the agency that covers the cost of drugs in the UK’s socialized healthcare system says the drug “cannot currently be considered good value for the taxpayer” due to its small therapeutic benefits, the cost of monitoring, and big risk for side effects.
Sound familiar? A few months ago, the U.K. approved Leqembi in a similar manner, with the country’s insurer indicating their unwillingness to pay for the drug.
Kisunla was approved for treating the early stages of Alzheimer’s disease in the U.S. and Japan. Like previous anti-amyloid drugs, Kisunla 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 But according to draft guidance by the country’s healthcare regulator, National Institute for Health and Care Excellence, NICE isn’t planning on covering Kisunla because the drug’s treatment benefits to patients are considered too small, and on top of that, NICE says, it is unclear that the benefits persist once someone stops treatment. The drug would cost tens of thousands of pounds per year out of pocket.
Anti-amyloid drugs are “eye-wateringly expensive, difficult to administer and potentially harmful,” Paul Morgan, the interim director of the UK Dementia Research Institute at Cardiff University said in a comment on the Science Media Center. “Balancing these against a modest impact on the disease, the decision made by NICE is understandable.”
The draft guidance also recommends against administering the drug to people who have two copies of the ApoE4 gene.
Drugmaker Eli Lilly released a statement about the U.K. approval — but did not mention the NICE decision.
NICE’s guidance is not final. The draft guidance is subject to a public comment period, which lasts until Nov. 20, after which point the drug review committee will reconvene and decide whether to stand its ground.