New Alzheimer’s drug deemed ‘unsuitable’ for PBS

Patients with early symptoms of Alzheimer’s disease wishing to access a promising new drug will have to spend thousands of dollars to do so, after a Pharmaceutical Benefits Scheme (PBS) application was rejected.
 
Following a meeting in July, the Pharmaceutical Benefits Advisory Committee (PBAC) ruled that donanemab (sold as Kisunla) comes with a high burden for both patients and the health system, and when combined with the risks and modest clinical impact ‘makes the drug unsuitable for PBS subsidy’.
 
‘While clinical trials demonstrated that donanemab can potentially delay the progression of early Alzheimer’s disease by approximately six weeks, the PBAC noted there is a lack of consensus among clinicians that these results would translate into meaningful improvements for patients,’ the committee said.
 
‘The PBAC considered the potential benefits too small and uncertain to justify the burden of this treatment on both patients and the health system.’
 
Dr Marita Long is the first GP appointed as an Honorary Medical Advisor for Dementia Australia and a Clinical Associate Professor for the Wicking Dementia Education and Research Centre.
 
She told newsGP that while she can understand the disappointment being felt by those with Alzheimer’s disease and their families, she is not surprised by the outcome.
 
‘They would have seen that first glimmer of hope that there is a drug that isn’t curative but can slow things down and buy people a little bit more time with a better quality of life,’ Dr Long said.
 
‘But the studies only go for 18 months, and so we probably are looking for a little bit more real-life data on how this pans out.
 
‘It’s also expensive … there’s monthly infusions and a lot of monitoring, and we know it’s only for a small percentage of people with Alzheimer’s disease. So, it’s not for everyone.’
 
Approved by the Therapeutic Goods Administration in May, donanemab has captured people’s attention as the first new treatment for early Alzheimer’s to be registered in Australia in 25 years and the first to address the underlying cause of the neurodegenerative disease.
 
In clinical trial findings, published in 2023, donanemab was found to slow clinical decline by 35% compared to the placebo at 18 months. It also resulted in 40% less decline in the ability to perform daily activities.
 
To be eligible for the treatment in Australia, adults with early symptoms of the disease must have a specific genetic profile and the confirmed presence of amyloid plaque in the brain.
 
A disease-modifying therapy, it works by helping immune cells to clear the amyloid plaques from the brain, which, if left untreated, could lead to impaired memory and thinking, and a reduced ability to carry out daily tasks.
 
Magnetic resonance imaging (MRI) scans are used both before and during treatment to monitor for brain bleeding and swelling.
 
However, without being listed on the PBS, patients who meet the criteria can only access the drug via a private prescription at a cost of approximately $4700 per infusion, every four weeks, over a period of 18 months. 
 
Dr Long says this highlights a serious inequity.
 
‘So, people who have got the capacity to access this drug can, and people who don’t can’t,’ she said.
 
‘That’s where it becomes very difficult, particularly for us in primary care where we have to share that disappointment with our patients that here’s a drug that might do something, but unless you’ve got the money, you can’t access it.’
 
General manager of Lilly, the company that manufactures donanemab, Tori Brown expressed her disappointment with the PBAC, saying the decision ‘doesn’t reflect the true value’ of the drug.
 
‘This negative outcome must prompt a national conversation about the importance of investing more in innovative medicines for our rapidly ageing population,’ she said.
 
‘As a community, we need to ask ourselves whether we’re happy to accept the cost of not treating people with early Alzheimer’s disease.
 
‘Aside from the significant health and aged care costs resulting from Alzheimer’s disease, there is enormous value in enabling Australians living with this disease to remain independent for longer, to enjoy a good quality of life, and to continue contributing to the economy, to communities and to their families.’
 
Alzheimer’s disease is the leading cause of dementia in Australia, accounting for approximately two-thirds of cases.
 
Despite the disappointment, however, Dr Long said patients and their families should still hold hope, highlighting that the discovery of disease-modifying treatments like donanemab provides important insight for the future.
 
‘There are still trials going on, so for people who can’t afford it, there is still the option of trials and there are other disease-modifying drugs that are being looked at as well,’ she said.
 
‘I’m sure that they [Lilly] will reapply once we get a bit of a handle on how things are going in Australia and of course we’ll be watching closely what happens in America where we’ll be seeing more live data.
 
‘We also need to be mindful that there are many things we can do to help people with a diagnosis of dementia. So, we should keep our optimism high.’
 
The manufacturer has confirmed it is working ‘to fully understand the implications’ of the PBAC’s decision, and potential next steps.
 
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