Alzheimer’s treatment approved in Australia
The newly approved drug Donanemad marks an important step forward in Alzheimer’s disease treatment, targeting the build up of amyloid plaque in the brain, but it comes with a hefty price tag and significant side effects.
Kisunla, or Donanemad, by American-based multinational pharmaceutical company Eli Lilly has been approved for use in Australia by the Therapeutic Goods Administration, signaling an exciting step forward in the treatment of Alzheimer’s disease, says Dementia Australia chief executive officer Tanya Buchanan.
For use in the early stages of Alzheimer’s disease, Donanemad is used to treat adults with early symptomatic Alzheimer’s disease and the confirmed presence of amyloid plaque in the brain – the excessive build up of which can disrupt the brain’s neurons and impede messages travelling normally, particularly messages relating to memory.
However, Donanemad treatment is only suitable for those with a specific genetic profile, as there are significant side effects, including brain swelling, said head of Dementia Research and Senior Clinician at Melbourne’s Memory Clinic at Austin Health Professor Michael Woodward.
“The registration of Donanemab is very exciting. As clinicians, we’ve been waiting a very long time to be able to offer patients a treatment of this nature,” he said.
“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. The availability of Donanemab is a major development at a time when more and more Australians and their families are being impacted by this insidious disease.”
Donanemad is not a cure for Alzheimer’s disease, but rather a treatment to delay the progression of symptoms, and requires an early diagnosis to be effective, Professor Buchanan added.
(Dementia Australia)
“We need to raise awareness and understanding of dementia so we can ensure people with concerns about their cognition are seeking information and support as early as possible,” she said.
“We know the earlier people access support and services, the better their health, care and lifestyle outcomes.”
Professor Buchanan also reiterated the need to monitor these new drugs and continue investing in dementia research so further drugs can be developed that treat all forms of dementia and dementia progression.
It is also important that access to treatment is equitable and available to everyone, Professor Buchanan said, but with the current lack of subsidy for Donanemad, treatment ranges between $40,000 and $80,000 per year – administered via monthly infusion.
Minister for Health and Ageing Mark Butler also welcomed the news of Donanemab’s approval at a press conference in Adelaide last Thursday.
“It’s obviously very exciting news to see the TGA has approved Donanemab, which is a new treatment for early stage Alzheimer’s from Eli Lilly. There’s been a lot of coverage and commentary about this drug over the last couple of years. Because we’ve known now for, pretty much, 40 years the role that the amyloid protein plays in the development of Alzheimer’s in particular, but we haven’t seen a therapy that would target and reduce the presence of amyloid on the brain. This does that,” he said.
Mr Butler did acknowledge the treatment was complicated, noting issues about using PET scans to detect the amyloid plaque and determine which patients would be eligible and likely to benefit from this medicine, and the side effects.
“I welcome the approval for Donanemab by the Therapeutic Goods Administration. There is still a fair way to go, though, to determine whether or not this will be reimbursed by the Federal Government and, if so, for which patients,” he said.
“The Pharmaceutical Benefits Advisory Committee, which essentially determines the advice to Government about which medicines do end up on the PBS, is considering this drug in July. There will also though, need to be consideration of the associated scanning that needs to take place for patients. First of all the PET scans to determine eligibility, but also pretty regular MRI scans over the course of treatment to determine whether or not there is any associated brain bleeding and whether the drug is having the desired effect in terms of the presence of amyloid on the brain.
“A bit of a way to go but very exciting news for the Alzheimer’s community,” he concluded.
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