Australia this week became the first country to officially approve the drug Donanemab, marking a historic step against Alzheimer’s disease. After all, researchers and medical professionals have certainly had their hopes raised by other investigational drugs. Originally led by clinical trials from Professor Woodward, it has the promise of slowing the progression of Alzheimer’s by approximately 30 percent.
Alzheimer’s disease is the most prevalent form of dementia. It is the greatest single external cause of death for women in Australia and second for men. Today, this breakthrough treatment offers hope to those living in the earliest stages of the disease. It is particularly advantageous for people living with low to moderate disease progression.
Donanemab’s mechanism clears amyloid protein buildup from the brain, a force long-known to disrupt neuronal communication. This removal may reduce amyloid levels to below diagnostic thresholds for some patients. This complex drug is fraught with risks that require vigilant oversight. It can lead to dangerous brain swelling and bleeding, in turn leading to potentially fatal side effects.
Availability and Administration
For a start, in Australia, you can already get Donanemab if you can afford it privately. Only with major cities cheering on its administration, from a deep bench of cognitive services. The treatment protocol consists of intravenous infusions every 4 weeks for up to a total of 18 months. As promising as this therapy is, at this steep cost—with annual administration expenses ranging between $40,000 and $80,000—additional revenue from biopharmaceuticals will be less than hoped.
Donanemab was approved in Australia, though it is not yet on the Pharmaceutical Benefits Scheme (PBS). Because of this, the federal government will not subsidize its expense. Consequently, this makes access to this revolutionary treatment unattainable for many average Australians unable to shell out the required funds to afford it.
“It slows the deterioration by about 30 percent and that’s very important because if you have Alzheimer’s you’re likely already in your 70s or 80s and to have another six or 12 months of being able to function, help with the grandkids, go to events, remember day-to-day activities — that’s going to significantly improve your life.” – Professor Woodward
Clinical Trials and Safety Concerns
Despite impressive clinical trial results under the leadership of Professor Woodward, Donanemab trials quickly found their way into safety concerns. In the course of these trials, three subjects died from complications arising from brain swelling or bleeding associated with the drug. About one fourth of clinical trial patients had an occurrence of swelling.
The Therapeutic Goods Administration (TGA) is mandating genetic testing prior to treatment with Donanemab. This test simply determines whether you carry the ApoE4 gene. Those who have two copies of this gene are much more likely to suffer harmful effects from the drug. They are just wrong if they do.
“I’m reassured by the fact there were very few people who had to discontinue the trial due to swelling or bleeding but we need to make sure people are being appropriately monitored.” – Professor Brodtmann
International Context
Just last year, the UK approved Donanemab. The National Health Service (NHS) refuses to subsidize it due to worries over its cost-effectiveness. This underscores lingering inequities that exist in delivering access to Alzheimer’s treatments, especially geographic disparities.
Despite these hurdles, experts are cautiously optimistic that Donanemab will make a positive difference to Alzheimer’s care in Australia. They go to lengths to stress that this drug is not a cure for the disease. It is an important first step toward getting a better handle on the disease.
“It’s not a cure and we need to manage expectations but it’s the very start of therapies I hope we will have and it is a chink in the armour.” – Professor Brodtmann
