I guess this is good in one way as it proves what ACW IS trying...

I guess this is good in one way as it proves what ACW IS trying to achieve but will it stop them getting a foothold in early?Thoughts?

Donanemab is given monthly, via intravenous infusion.What does the evidence say?Australia’s approval of donanemab comes as a result of a clinical trial involving 1736 people published in 2023.This trial showed donanemab brought a significant slowing of disease progression in a group of patients who had either early Alzheimer’s disease, or mild cognitive impairment with signs of Alzheimer’s pathology. Before entering the trial, all patients had the presence of amyloid protein detected via PET scanning.Participants were randomised, and half received donanemab, while the other half received a placebo, over 18 months.The accumulation of amyloid plaques in brain tissue is a hallmark of Alzheimer’s disease. Photo: AAPFor those who received the active drug, their Alzheimer’s disease progressed 35 per cent more slowly over 18 months compared to those who were given the placebo. The researchers ascertained this using the Integrated Alzheimer’s Disease Rating Scale, which measures cognition and function.Those who received donanemab also demonstrated large reductions in the levels of amyloid in the brain (as measured by PET scans). The majority, by the end of the trial, were considered to be below the threshold that would normally indicate the presence of Alzheimer’s disease.These results certainly seem to vindicate the amyloid hypothesis, which had been called into question by the results of multiple failed previous studies. They represent a major advance in our understanding of the disease.That said, patients in the study did not improve in terms of cognition or function. They continued to decline, albeit at a significantly slower rate than those who were not treated.The actual clinical significance has been a topic of debate. Some experts have questioned whether the meaningfulness of this result to the patient is worth the potential risks.Is the drug safe?Some 24 per cent of trial participants receiving the drug experienced brain swelling. The rates rose to 40.6 per cent in those possessing two copies of a gene called ApoE4.Although three-quarters of people who developed brain swelling experienced no symptoms from this, there were three deaths in the treatment group during the study related to donanemab, likely a result of brain swelling.These risks require regular monitoring with MRI scans while the drug is being given.Some 26.8 per cent of those who received donanemab also experienced small bleeds into the brain (microhaemorrhages) compared to 12.5 per cent of those taking the placebo.Cost is a barrierReports indicate donanemab could cost anywhere between $40,000-$80,000 each year in Australia. This puts it beyond the reach of many who might benefit from it.Eli Lilly, the manufacturer of donanemab, has applied for the drug to be listed on the Pharmaceutical Benefits Scheme, with a decision pending perhaps within a couple of months. While this would make the drug substantially more affordable for patients, it will represent a large cost to taxpayers.The cost of the drug is in addition to costs associated with the monitoring required to ensure its safety and efficacy (such as doctor visits, MRIs and PET scans).Donanemab won’t be accessible to all patients with Alzheimer’s disease. Photo: GettyWho will be able to access it?This drug is of benefit only for people with early Alzheimer’s-type dementia, so not everybody with Alzheimer’s disease will get access to it.Almost 80 per cent of people who were screened to participate in the trial were found unsuitable to proceed.The terms of the TGA approval specify potential patients will first need to be found to have specific levels of amyloid protein in their brains. This would be ascertained either by PET scanning or by lumbar puncture sampling of spinal fluid.Also, patients with two copies of the ApoE4 gene have been ruled unsuitable to receive the drug. The TGA has judged the risk/benefit profile for this group to be unfavourable.