Time for action in Alzheimer’s disease as new treatments advance
Expert leaders in the dementia field are calling for changes to the Australian health care system to enable appropriate use of new Alzheimer’s disease treatments, including monitoring their safety and value, setting up adequate facilities for diagnosis and delivery and greater education and training of health professionals.
A perspective article published earlier this year in the highly reputable journal, Medical Journal of Australia, by lead author and Monash University Cognitive Health Initiative group leader (Department of Neuroscience, Central Clinical School) Professor Amy Brodtmann, explores the question surrounding the therapeutic advancement in the Alzheimer’s field as to whether Australasia is ready for disease-modifying therapies. “In short, we do not feel Australia is ready at present. We need to provide diagnostic expertise, resources, and monitoring capacity for our patients. However, with some modifications and additions, we could be,” said Professor Brodtmann.
Aducanumab, a disease-modifying therapy, was granted FDA approval controversially in June 2021. Although an application for the drug was filed to the Therapeutic Goods Administration (TGA) in the same year, the application was withdrawn in Australia a year later. In January this year, another disease-modifying therapy, lecanemab, similarly received FDA approval, and is currently being considered approval by the TGA. Another disease-modifying therapy, donanemab, may follow later. These approvals reflect the excitement in a field without any prior drug treatments. But the drugs come with significant risks and practical obstacles, not least their high price tag, while offering limited clinical benefit.
“The focus cannot just be on the statistical effectiveness of these treatments – we need to focus on clinical benefit. They are associated with increased brain volume loss (atrophy) and reactions from intravenous administration, which are major risks to the safety of patients. The treatments do not meet all the accepted criteria for clinical benefit so it is critical for phase 4 clinical trials to continue,” explained Professor Brodtmann.
Patients currently receiving disease-modifying treatment for Alzheimer’s Disease in the US (where it is approved for use) are required to have frequent monitoring with MRI - four or more per year - and fortnightly or monthly intravenous infusions. There is limited capacity for regular intravenous infusions in most Australian clinical settings, and no Medicare coverage for multiple MRI scans in a single year for people with dementia. ”We need to prepare for an increase in the demand for these services and staff.”
Diagnosis of dementia occurs in multidisciplinary memory clinics. Professor Brodtmann runs the Eastern Cognitive Disorders Clinic at Box Hill Hospital in the Eastern Health network, opened in 2006 in response to the need for a specialist frontotemporal dementia clinic. “We know that the majority of patients receive a diagnosis in hospital outpatient settings, such as memory clinics and the Victorian government funded Cognitive Dementia And Memory Services. These have highly skilled staff and extensive experience, but the reach and capacity of these services needs to be increased nationally.”
If approved, a patient who would like to be considered for one the new Alzheimer’s treatments would need to have their diagnosis confirmed with PET imaging or biomarker testing using a sample of cerebrospinal fluid. Currently, this is not covered by Medicare, so patients would need to pay out of pocket expenses on top of the high costs of the treatments.
Earlier diagnosis enables timely management with supportive care but with current treatment only able to treat the symptoms and no cure, patients are reluctant to see a doctor for diagnosis. “Interestingly, treatment of patients occurs primarily in primary care so we need to increase the dementia-care medical workforce and upskill healthcare professionals.”
Alzheimer’s disease is one of the main types of dementia. The Australian Institute of Health and Welfare (AIHW) released an update this week to their Dementia in Australia report that states an estimated 401,300 Australians live with dementia and will more than double by 2058. Dementia is the second leading cause of disease burden and death, with $3 billion spent on dementia health and aged care in 2018-19. Dementia including Alzheimer’s disease was the leading cause of death for females, accounting for 10,276 (13%) deaths, in the last AIHW release.
This week is Dementia Action Week (18-24 September), with World Alzheimer’s Day on Thursday 21 September. Dementia Australia, a not for profit organisation supporting Australians living with dementia and their families, is inviting people to take a pledge to create dementia-friendly future communities.
Professor Amy Brodtmann will be part of an expert panel as part of a free webinar hosted by Dr Norman Swan on Tuesday 26 September, titled, “New Treatments for Alzheimer’s Disease are almost upon us - How do they change general practice?” discussing concerns about the gaps in the health care system. To attend the webinar, register here.
With disease-modifying therapies poised to enter the Australian and New Zealand market, more action to reduce the gaps and provide best practice for patients will be essential.
About Monash University
Monash University is Australia’s largest university with more than 80,000 students. In the 60 years since its foundation, it has developed a reputation for world-leading high-impact research, quality teaching, and inspiring innovation.
With four campuses in Australia and a presence in Malaysia, China, India, Indonesia and Italy, it is one of the most internationalised Australian universities.
As a leading international medical research university with the largest medical faculty in Australia and integration with leading Australian teaching hospitals, we consistently rank in the top 50 universities worldwide for clinical, pre-clinical and health sciences.
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