A Perth professor of geriatric medicine is cautioning that new medicine approved in Australia to treat the early symptoms of Alzheimer’s disease may not be the game-changer many are hoping it to be.
Director of the Western Australian Centre for Health and Ageing Professor Leon Flicker said there were a number of things people with Alzheimer’s could do that are cheaper and have the same benefits without the side effects.
Donanemab, sold under the brand name Kisunla, works to remove the build-up of a protein in the brain that can lead to memory loss and impaired thinking.
It has been approved by the TGA for the treatment of adults with early symptomatic Alzheimer’s disease who have a specific genetic profile and the confirmed presence of amyloid plaque in the brain.
The excessive build-up of amyloid plaques in the brain can disrupt the brain’s neurons and prevent messages from travelling normally.
Such a build-up can lead to memory and thinking issues such as remembering new information, important dates and appointments; planning and organising events; making meals; using household appliances; managing finances; and being left alone safely.
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Professor Michael Woodward, Head of Dementia Research and Senior Clinician of the Memory Clinic at Austin Health in Melbourne said clinicians had been waiting “a very long time to be able to offer patients a treatment of this nature”.
“There is an important window of opportunity when it is possible to detect, diagnose and treat Alzheimer’s disease with the goal that patients can maintain their independence for longer,” he said.
“The availability of donanemab is a major development at a time when more Australians and their families are being impacted by this insidious disease.”
But Professor Flicker said given the drug was expected to result in just 30% less decline in patients “most people won’t notice anything, apart from side effects of the medication”.
“The effect size of the treatment is very small and is below what previously was specified as meaningful clinical improvement. To put that in perspective, over 18 months, the change in the Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog) is 1.35,” he said.
“The question is whether this is a meaningful improvement to the side effect profile.”
Professor Flicker said the medicine was associated with an “incredible number” of side effects including amyloid-related imaging abnormalities.
On top of that, Professor Flicker said donanemab was an expensive medication that was expected to cost between $40,000 and $80,000 a year.
Instead, he said other lifestyle measures may be just as helpful to slow the onset of symptoms of Alzheimer’s. This includes stopping smoking, reducing alcohol intake and keeping physically active.
He said these were proven effective in slowing the onset of Alzheimer’s symptoms, adding they had “not dissimilar effects” to donanemab but did not have negative side effects.
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About 600,000 Australians are currently living with Alzheimer’s disease, with approximately 450,000 of these in the early stages of the disease.
Tori Brown, the Australia and New Zealand General Manger of Eli Lilly the pharmaceutical company behind the medication, said the registration of Kisunla in Australia was a pivotal moment that will redefine how Alzheimer’s disease is managed when symptoms first present.
“This must act as a catalyst for change, ensuring Australia’s healthcare system is equipped to support the early detection, diagnosis and treatment of Alzheimer’s disease.
“This must include practical guidelines and new pathways for the early detection and diagnosis of Alzheimer’s disease, alongside timely government reimbursement of therapies to support patient access and affordability.”
An application to include Kisunla on the Pharmaceutical Benefits Scheme (PBS) will be reviewed by the Pharmaceutical Benefits Advisory Committee in July.
Doctors can prescribe the medicine, which is administered via infusion every four weeks, via private prescriptions.
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