Is Australia ready for amyloid-targeting therapies in Alzheimer’s disease?

With the Pharmaceutical Benefits Advisory Committee (PBAC) scheduled to consider Eli Lilly’s amyloid-targeting monoclonal antibody, Kisunla (donanemab), at its July 2025 meeting, attention is turning to whether the healthcare system is prepared for the rollout of this novel therapy for Alzheimer’s disease.

Alzheimer’s is the most common form of dementia, affecting more than 400,000 Australians. It is also the leading cause of death for women, underscoring the urgent need for disease-modifying treatments.

A national clinician survey involving neurologists, geriatricians and psychiatrists from 30 clinics – 76.7% public and 23.3% private – across metropolitan (73.3%), regional (20.0%) and rural (6.7%) areas, paints a sobering picture. The findings indicate that significant improvements to infrastructure, workforce capacity, and clinical training will be required to ensure equitable access to amyloid-targeting therapies.

Clinicians were asked to identify the greatest gaps in adopting amyloid-targeting treatments within their services. They cited a lack of real-world experience, indicating the need to translate treatment protocols from clinical trials into routine practice. There is currently a lack of clear models of care and appropriate guidelines around infusion processes and ongoing therapy monitoring. Many clinics are not equipped to deliver on-site IV infusions, lacking even a basic infusion chair.

Concerns were also raised about the management of safety risks, particularly identifying and addressing amyloid-related imaging abnormalities (ARIA), and ensuring appropriate ongoing safety monitoring.

The scale of system readiness is further challenged by current service limitations. International data reveals that only about 8% of memory clinic patients would qualify for amyloid-targeting antibody therapy if the strict eligibility criteria from clinical trials were applied to real-world clinical practice.

On average, Australian memory and cognition clinics assess 5.4 patients per week, of which only 2 may have mild cognitive impairment (MCI). The ADNeT Clinical Quality Registry data supports this, showing that only 32% of new clinic cases meet MCI criteria (not all due to Alzheimer’s disease).

Concerningly, many gold-standard clinics operate only 1–2 days a week and collectively reach just 5% of the MCI/dementia population, revealing a significant gap between current capacity and anticipated demand.

Recent estimates also suggest that of the 12,000 patients attending public memory clinics annually, only about 1,000 (8%) could be eligible for amyloid-targeting monoclonal antibody therapy, assuming current capacity and infrastructure. However, with approximately 250,000 new MCI/dementia cases annually, around 20,000 could be suitable for treatment, indicating that existing public clinics would serve just 5% of eligible patients.

Should Kisunla receive PBS listing, Australia would require significant investment across both public and private sectors. Priorities would include increased access to Aβ-PET imaging or lumbar puncture for CSF biomarker testing, infusion infrastructure, expansion of the nursing and administrative workforce, and routine neuroradiological review.

Looking forward, emerging blood-based biomarkers may streamline early detection and integrate more seamlessly with primary care. A national clinical trial evaluating these markers, led by Professors Christopher Rowe, Sharon Naismith and James Vickers across Austin Health, University of Sydney and University of Tasmania, wrapped up data collection in January 2025.

As Australia approaches a potential turning point in Alzheimer’s treatment, system-wide readiness remains a critical question. The path forward will demand coordinated action, sustained funding, and a commitment to reshaping how equitable care is delivered.

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