1738 – Two testing options to detect early-stage Alzheimer's Disease, to determine eligibility for PBS subsidised lecanemab treatment

Page last updated: 15 February 2024

Application Detail

Description of Medical Service

The proposed services are two testing options, either of which could be used to detect the presence of amyloid beta (Aß) pathology in patients with Alzheimer’s Disease. The two tests are Aß positron emission tomography (PET) imaging and cerebrospinal fluid (CSF) AD biomarker testing. A positive test result is to be used to determine patient eligibility to the drug treatment, lecanemab. A separate application will be made to the Pharmaceutical Benefits Advisory Committee for subsidy of the drug.

Description of Medical Condition

Alzheimer’s Disease is a progressive, neurodegenerative disorder, characterized by an unrelenting decline in cognition and behavioural disturbances, that result in the person’s inability to perform usual daily living activities. The pathophysiology is related to the injury and death of neurons, initiating in the hippocampus brain region that is involved with memory and learning, followed by gradual atrophy of the entire brain. Early symptoms include difficulty with recent memories, apathy, and depression. Later symptoms include impaired communication, disorientation, confusion, difficulty speaking, swallowing and walking.

Reason for Application

MSAC-PBAC co-dependent submission

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1871 KB)
Application Form (Word 563 KB)

Consultation Survey

Consultation Survey (PDF 655 KB)
Consultation Survey (Word 33 KB)

PASC Consultation
Bypassing PASC

MSAC Consultation
MSAC consultation input must be received by no later than Friday, 14 June 2024 for it to be considered by MSAC at its August 2024 meeting.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

Bypassing PASC

ESC

13-14 June 2024

MSAC

1-2 August 2024