Treatment to slow early Alzheimer’s gets TGA approval

GPs can expect to see more patients seeking help for cognitive decline, following the Therapeutic Goods Administration (TGA) listing of a breakthrough drug to treat patients in the early stages of Alzheimer’s disease.
 
Donanemab (sold as Kisunla) was registered by the TGA on Wednesday – the first new treatment for early Alzheimer’s in Australia in 25 years, according to its manufacturer.
 
The treatment is approved for adults with early symptomatic Alzheimer’s disease who have a specific genetic profile and the confirmed presence of amyloid plaque in the brain.
 
However, cost is a potential barrier for many patients as well as access to health services for regular MRIs and scans. The private prescription price for donanemab is approximately $4700 for each infusion, administered monthly, with treatment lasting up to 18 months.
 
The drug’s manufacturer, Eli Lilly, said an application to include Kisunla on the Pharmaceutical Benefits Scheme will be reviewed by the Pharmaceutical Benefits Advisory Committee in July.
 
The drug works by inducing antibodies designed to attach to and remove amyloid plaques from the brain.
 
A phase three clinical trial of 1736 people with early Alzheimer’s disease found the drug slowed cognitive and functional decline by up to 35%, compared to placebo at 18 months.
 
Dementia Australia CEO Professor Tanya Buchanan described the TGA approval as an exciting development and another step forward in treatment of the condition. 
 
‘With dementia the second leading cause of death of Australians, and the leading cause of death of Australian women, we welcome any steps taken towards improving the lives of people living with dementia, their families and carers,’ she said.
 
‘It is important to note that donanemab does come with possible side effects that need to be carefully communicated to patients so they can make an informed choice, and the treatment needs to be monitored by health professionals.’
 
Dr Stephanie Daly, a GP with a special interest in dementia and coordinator of the RACGP Specific Interests Dementia sub-group, said she expects, and hopes, the news will encourage patients to see their GPs early about concerns with cognition – particularly those who may have delayed appointments thinking there is nothing that could be done.
 
‘It’s exciting because there have been lots of other types of drugs like this which haven’t shown any benefit, and now this one has shown some benefit,’ she told newsGP.
 
‘We know that people still continue to decline, but it does seem to slow decline in individuals, provided you start it early enough.
 
‘Slowing down a condition that is progressive is advantageous for people because it might enable them to maintain their independence for longer and stay at home for longer, which is what most people want.’
 
Despite the current high cost, Dr Daly warns the health system needs to be prepared for the shift it could bring.
 
‘There’s a lot of education that needs to happen right across the health system; not just in primary care but also in emergency departments and other places where people will come in contact with health professionals,’ she said.
 
‘And while GPs aren’t prescribing it, often patients will come to us and say, what do you think of this medication? Should I be taking it? I’ve got this side effect, should I call my specialist?
 
‘So, there’s a bit of education required for primary care around that as well.’
 
Two potential side effects of brain swelling and bleeding have been noted by Kisunla’s manufacturer Eli Lilly, however these were most common in people who carry two copies of a common gene variant (ApoE ε4) that elevates the risk of developing Alzheimer’s disease.
 
‘Patients must therefore be tested to determine their ApoE ε4 status before starting the therapy. Doctors use [MRIs] to monitor for brain bleeding and swelling before and during treatment,’ the company stated.
 
There are also challenges that come with the early window of opportunity to detect, refer and treat the select group of patients eligible for donanemab.
 
‘The people in whom this medication works best are people with mild cognitive impairment – they’ve got some changes in their cognition, but it’s not affecting their function,’ Dr Daly said.
 
‘That can actually be quite hard to identify in primary care because we’ve got to be looking for it, so as a clinic, as a community of practitioners, we have to try to identify that.
 
‘And traditionally, we’ve probably picked up dementia when it’s more advanced, which is also important to note for this medication because we don’t want to be referring people that are not eligible for it.
 
‘Is the primary care community ready for that? Have we had enough time to educate people about what mild cognitive impairment is and how to pick up those early signs?
 
‘And if we are then identifying lots more people, and the GPs are doing what they perhaps they think is the best thing and referring all these people on to secondary care to consider for these medications, are we then going to create a bottleneck?’
 
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Alzheimer’s disease donanemab TGA Therapeutic Goods Administration