PBAC's latest decision on Donanemab: Recommended with restriction (2025). Considered for Treatment of patients with early symptomatic Alzheimer's disease, defined as mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia, who are apolipoprotein E ε4 (APOE4) heterozygotes or non-carriers and have beta-amyloid positivity confirmed by validated testing.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Patients aged 60 years or older with early symptomatic AD (MCI due to AD or mild AD) who are not homozygous for the APOE4 allele and have evidence of amyloid-beta pathology confirmed by either Aβ-PET or cerebrospinal fluid AD biomarker testing
Therapy area
Neurology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Cognitive and functional outcomes (iADRS, CDR-SB, ADAS-Cog13, CDR-G, ADCS-iADL, MMSE) and amyloid clearance
Key trials
TB-6, TB-2
Comparator
Standard of care (non-pharmaceutical interventions including observation, monitoring, brain health optimisation, and symptomatic treatments such as acetylcholinesterase inhibitors)