PBAC rejects funding for first Alzheimer’s drug in two decades

The Pharmaceutical Benefits Advisory Committee (PBAC) has rejected a recommendation for Eli Lilly’s Kisunla (donanemab) to be subsidised through the Pharmaceutical Benefits Scheme (PBS) for patients with early symptomatic Alzheimer’s disease. The decision comes despite Kisunla being the first Alzheimer’s treatment in more than 20 years to be approved by the TGA in May this year.

“This is a disappointing outcome for patients, their families, the Alzheimer’s community, and for Lilly,” said Tori Brown, General Manager, Lilly Australia & New Zealand. “It’s a decision that doesn’t reflect the true value of Kisunla for patients, their families, the health system and society as a whole. This negative outcome must prompt a national conversation about the importance of investing more in innovative medicines for our rapidly ageing population.”

Alzheimer’s disease affects an estimated 600,000 Australians, with roughly 450,000 in the early stages who could be assessed for eligibility to receive Kisunla.

Yet, the pathway to broad access remains constrained by system-wide challenges. A recent national clinician survey, including neurologists, geriatricians, and psychiatrists, highlighted significant gaps in readiness to deliver new Alzheimer’s therapies.

Clinicians reported limited infrastructure, particularly IV infusion facilities, and a lack of clear care models to guide treatment and monitoring. They also raised concerns about safety risks, such as amyloid-related imaging abnormalities (ARIA), with no structured oversight systems currently in place. These barriers align with some of the issues cited by the PBAC in its decision not to recommend funding for Kisunla.

“As a community, we need to ask ourselves whether we’re happy to accept the cost of not treating people with early Alzheimer’s disease. Aside from the significant health and aged care costs resulting from Alzheimer’s disease, there is enormous value in enabling Australians living with this disease to remain independent for longer, to enjoy a good quality of life, and to continue contributing to the economy, to communities and to their families,” Brown added.

She continued, “We also mustn’t lose sight of the impact of this disease on carers, who are often invisible, and spend on average 60 hours a week looking after someone with Alzheimer’s disease. Lilly is working to fully understand the implications of this outcome and potential next steps.”

The clinician survey further suggests that initial real-world rollout of amyloid-targeting monoclonal antibody therapies like Kisunla will likely be slow and concentrated in metropolitan centres. Workforce and infrastructure limitations remain a major barrier in regional and rural areas. Over time, however, advances such as service expansion, plasma biomarker screening for Alzheimer’s disease, and optimised drug delivery methods, including subcutaneous administration, are expected to support more equitable access.

For now, Kisunla will only be available in Australia through private prescription and inaccessible to many patients.

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