DonanemabKisunla
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.
Decision on record
- Meeting Jul 2025 Not recommended Early symptomatic Alzheimer's disease
Access path
- TGA registered · Kisunla
TGA label narrower than the PBS population
- Jul 2025Not recommended
vs Standard of care (non-pharmaceutical interventions…
From the public summary
7.1 The PBAC did not recommend donanemab for the treatment of patients with early symptomatic Alzheimer’s disease (AD), defined as mild cognitive impairment (MCI) due to AD or mild Alzheimer’s dementia (referred collectively to as early AD).PSD · Jul 2025
Furthermore, the PBAC considered that pharmacotherapy was only one aspect of the public health response to AD, and that the proposed donanemab listing would require an extremely high investment in the PBS without regard for the broader health and aged care budgets.PSD · Jul 2025
6.107 The submission presented a modelled economic evaluation based on the treatment effect observed in the TB-2 trial which compared donanemab treatment to SOC in patients with early AD with a positive amyloid-beta biomarker test and who were not APOE4 homozygotes. The type of economic evaluation presented was a cost-utility analysis. Key components of the model are summarised in Table 18.PSD · Jul 2025
Table 18: Summary of model structure, key inputs and rationale Component Summary Comparison Donanemab with amyloid and APOE4 testing versus SOC. Outcomes QALYs.PSD · Jul 2025
amyloid testing and treatment with SOC in terms of effectiveness and has an inferior but manageable safety profile. Source: Table 1-1, p16 of the submission.PSD · Jul 2025
Aβ=amyloid beta; Aβ-PET=amyloid beta positron emission tomography; AD=Alzheimer’s disease; ADCS-iADL=Alzheimer’s Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment; ADAS-Cog13=Alzheimer’s Disease Assessment – Cognitive subscale; AE=adverse events; ARIA-E=amyloid-related imaging abnormality-(o) edema; ARIA-H=amyloid-related imaging abnormality haemorrhage; CDR-SB=Clinical Dementia Ratings Scale – Sum of Boxes; …PSD · Jul 2025
6.2 The PBAC noted and welcomed the input from individuals (12) and organisations (3) via the Consumer Comments facility on the PBS website. The comments described the high unmet need for efficacious therapies, the impacts of AD on patients and their families and the hope offered by donanemab to potentially enable individuals to sustain their contribution to society, remain independent and have more time to enjoy activities with family and friends.PSD · Jul 2025
6.3 The PBAC noted the advice received from the Australian Dementia Network (ADNet) highlighted the clinical value and public health importance of ensuring equitable access to treatments such as donanemab. ADNet highlighted the results of the TB-2 trial and noted that there are now practical ways to manage ARIA and other adverse events. ADNET also offered assistance with roll out and monitoring of the disease modifying therapies.PSD · Jul 2025
Cost-effectiveness
ICER value is redacted (commercially sensitive)
Decision context
PopulationPatients 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Not recommended | Standard of care (non-pharmaceutical interventions including observation, monitoring, brain health optimisation, and sym | — | RCT · Cognitive and functional outcomes (iADRS, CDR-SB, ADAS-Cog13, CDR-G, ADCS-iADL, MMSE) and amyloid clearance |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| APOE4 genotyping and amyloid-beta pathology testing (PET or CSF) to determine eligibility for donanemab | amyloid-beta pathology and APOE4 genotype | not supported | 2025 |
Consumer voice
Consumer input from 12 individuals and 3 organisations described high unmet need for Alzheimer's disease therapies, impacts on patients and families, and hope that donanemab could help patients remain independent and maintain quality of life. Some concerns were raised about potential side effects and the need for equitable access across all populations.
the high unmet need for efficacious therapies, the impacts of AD on patients and their families and the hope offered by donanemab to potentially enable individuals to sustain their contribution to society, remain independent and have more time to enjoy activities with family and friends. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds age restriction (≥60 years) and specifies first-line use not present in TGA label.