Applications

1784 – Testing options to detect amyloid beta pathology and determine APOE genotype in patients with mild cognitive impairment due to Alzheimer’s disease, or mild Alzheimer’s disease, to determine eligibility for PBS subsidised donanemab treatment

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input, and the outcome of the application when the MSAC process is complete.

  • Status Assessment
  • Type New application
  • Pre-PASC consultation Not applicable
  • Pre-MSAC consultation Open
  • Outcome Pending

Application details

Applicant

Eli Lilly Australia Pty Ltd

Reason for application

New Medicare Benefits Schedule items

Service or technology in this application

A test to determine apolipoprotein E (APOE) genotype and two testing options to assess beta-amyloid (Aß) pathology (Aß positron emission tomography (PET) and cerebrospinal fluid (CSF) AD biomarker immunoassay), in patients with a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease, or mild Alzheimer’s disease. 

Type: Investigative technology

Medical condition this application addresses

Alzheimer’s disease (AD) is a progressive neurodegenerative disease, and the most common form of dementia, accounting for 60-80% of all dementia cases. The pathological hallmark of AD is the accumulation of amyloid beta (Aß) protein plaques, followed by the development of neurofibrillary tangles composed of tau protein within neurons and other characteristic brain changes, resulting in neuronal dysfunction and brain atrophy. The earliest clinical manifestations of AD can be a subjective decline in mental abilities which does not impact performance on objective cognitive tests but as the disease progresses, people living with AD show more advanced symptoms with changes that negatively impact memory and eventually impacting one’s ability to perform basic activities of daily living (ADLs), such as cooking and dressing.

Application documents

Application summary

PICO set

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Consultation survey and deadlines

The following consultation deadlines apply:

  • Pre-PASC consultation deadline: Bypassing PASC
  • Pre-MSAC consultation deadline: Friday 13 June 2025 11:59 pm AEST  

For other ways to provide input, see how to have your say.

We welcome input from everyone. We are especially keen to hear from those with lived experience of the health condition, service or technology the applications are addressing.

Find out more about consultation.

Meetings to consider this application

This application will be considered at the following meetings:

  • PASC meeting: Bypassing PASC
  • ESC meeting: 12-13 June 2025
  • MSAC meeting: 31 July - 1 August 2025

Find out more about our meetings.

Outcome details

The outcome of this application is pending.

More information

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