Alzheimer’s Centre marks new era but patient access hits construction zone

Federal Health Minister Mark Butler has officially opened the Asia Pacific Centre of Excellence for Alzheimer’s Diagnosis, a collaboration between Neuroscience Research Australia (NeuRA) and Roche Diagnostics Australia.

The launch follows a Memorandum of Understanding (MOU) announced earlier this week between NeuRA, Roche Diagnostics Australia and Lilly Australia to develop a blueprint for healthcare system readiness. The initiative aims to address critical gaps in early detection, treatment access and clinical infrastructure as Australia prepares for a new generation of Alzheimer’s diagnostics and therapies.

More than 450,000 Australians are currently living with dementia, which costs the nation more than $18 billion annually. Dementia remains Australia’s leading cause of death, with Alzheimer’s disease accounting for approximately 75% of all dementia cases.

The new Centre will utilise blood-based and spinal fluid biomarkers, including Roche’s Elecsys pTau217 and pTau181 blood tests, to support Alzheimer’s disease diagnosis and identify pathological changes up to 20 years before clinical symptoms emerge.

NeuRA CEO Professor Matthew Kiernan AM said the partnership would position Australia at the forefront of precision diagnostics for neurodegenerative disease.

“As Roche develops diagnostic tools across the span of neurodegenerative disease, it’s at NeuRA where they can be tested and validated for the Asia-Pacific region, delivering a new era of personalised, precise clinical care,” stated Professor Kiernan.

While advances in diagnostics continue, translating them into routine clinical care remains a significant policy challenge. In Australia, Medicare Benefits Scheme (MBS) funding for in vitro diagnostics (IVDs) can be delayed by up to eight years after regulatory clearance because of the complexity and cost associated with generating local evidence and meeting health technology assessment (HTA) requirements.

Minister Butler acknowledged that Roche’s blood test is available through the private market. However, he said Medicare reimbursement requires the company to gather Australian data, despite Roche having presented international clinical results at the recent Alzheimer’s Association International Conference (AAIC).

“It relies upon the cooperation of Roche Diagnostics to use this opportunity to present Australian clinical data that shows the test is effective,” said Minister Butler. “The company would then present that to the experts that oversee our Medicare schedule. If they’re satisfied about it, it would be added to the MBS schedule and then would attract a Medicare payment for patients willing to do it.”

The Centre’s establishment also comes as disease-modifying therapies begin to reshape the Alzheimer’s treatment landscape. Despite the Therapeutic Goods Administration’s (TGA) approval of Lilly’s Kisunla (donanemab) in 2025, the first disease-modifying therapy for Alzheimer’s disease in two decades, patient access remains constrained as the medicine has yet to be listed on the Pharmaceutical Benefits Scheme (PBS). Existing treatment options focus largely on symptom management rather than slowing disease progression.

“There’s been some new medicines that have come onto the market globally that modify the disease, don’t cure it and don’t even reverse it. At best, they slow it down,” said Minister Butler. “For decades now, pharmaceutical companies have been ploughing billions of dollars into research to find a medicine that really cracks this disease for good, and they haven’t yet done that.”

Alongside advances in diagnostics, Roche used the AAIC to highlight progress across its Alzheimer’s treatment pipeline. The company presented the latest findings on trontinemab, an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal antibody. New long-term safety, amyloid removal and biomarker data from the Phase Ib/IIa Brainshuttle AD extension study were presented, with modelling from the study informing the dosing regimen for the Phase III TRONTIER 1 and TRONTIER 2 trials in early symptomatic Alzheimer’s disease.

For the first time, Roche also unveiled the design of PrevenTRON, a Phase III study investigating trontinemab in preclinical Alzheimer’s disease. The trial is expected to recruit cognitively unimpaired individuals at high risk of progressing to symptomatic Alzheimer’s disease, with investigators using Roche’s Elecsys pTau217 blood test to help identify potential study participants.

“There are all of these questions. How do you prevent people getting it? How do you diagnose the condition quickly so the family can get support as quickly as possible? When are we going to get a medicine that makes a real difference to patients?’ Minister Butler reflected. “These are the diabolically difficult questions around a condition that impacts so many Australian families.”

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