Eli Lilly’s Alzheimer’s Drug Kisunla (Donanemab) Receives Marketing Authorization in Australia

Australia’s Therapeutic Goods Administration (TGA) has approved Kisunla™ (donanemab-azbt), a monoclonal antibody developed by Eli Lilly, for the treatment of early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology. This marks the first new Alzheimer’s treatment in 25 years that targets the underlying cause of the disease by removing amyloid plaques in the brain.

Kisunla is administered intravenously once a month for up to 18 months. Clinical trials have shown that it can slow cognitive and functional decline by approximately one-third compared to placebo in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease.

However, the treatment is not suitable for all Alzheimer's patients. Only 10–20% of Australia's estimated 400,000 dementia patients are likely to be eligible, due to strict criteria including early-stage diagnosis, specific genetic markers, and risk assessments for side effects like brain swelling and bleeding.

The cost of Kisunla treatment, which includes drug and diagnostic expenses such as MRI scans and PET imaging, may exceed $80,000. Currently, it is not covered by Medicare or the Pharmaceutical Benefits Scheme (PBS). Eli Lilly has applied for PBS listing, with a review by the Pharmaceutical Benefits Advisory Committee scheduled for July.

Alzheimer's disease affects around 600,000 Australians, with approximately 75% in the early stages. The disease's economic impact is projected to more than double by 2050, reaching $17 billion . Experts and advocates consider Kisunla's approval an important advance in dementia care, while emphasizing the need for improved diagnostic pathways and government support to ensure affordability and accessibility.

Eli Lilly remains committed to advancing treatments for Alzheimer's disease and continues to work with regulatory authorities to expand access to Kisunla in other regions. However, currently, the National Institute for Health and Care Excellence (NICE) has not recommended Kisunla for use on the National Health Service (NHS) due to concerns about its cost-effectiveness. NICE's independent committee concluded that while Kisunla can slow cognitive decline by four to seven months, the benefit does not justify the high cost to the NHS.