1643 - Two testing options for determining eligibility for access to Pharmaceutical Benefits Schedule-subsidised aducanumab in patients with early stage Alzheimer Disease

Page last updated: 28 June 2021

Application Detail

Description of Medical Service

The application requests consideration of two alternative methods for detecting presence of beta-amyloid (A) pathology in patients: A positron emission tomography (PET) and cerebrospinal fluid (CSF) Alzheimer Disease (AD) protein biomarker testing. A PET offers direct confirmation of the presence of A brain pathology. PET is a minimally invasive diagnostic imaging technique used to distinguish normal from abnormal tissue in numerous indications including neurologic disorders. It is the only antemortem imaging technique that can directly confirm the presence of A brain pathology. A PET imaging employs a radioisotope labelled tracer that is intravenously administered and travels to the brain to selectively bind A aggregates. A PET creates an image which can inform on the density and location of the amyloid plaques within the brain.CSF AD biomarker testing also assesses the presence of A and tau brain pathology. Testing for CSF AD biomarkers is an alternative to A PET to confirm A pathology in order to determine eligibility for access to PBS-subsidised aducanumab. CSF AD biomarker testing is performed by in vitro immunoassays. A CSF sample is obtained by lumbar puncture using a standardised collection procedure. Concentrations of specific biomarkers (amyloid -42 peptides, total tau and phosphorylated tau) in the sample are then quantified by in vitro immunoassay methods, and amyloid positivity or negativity determined.The co-dependent intervention, aducanumab, is a proposed disease modifying medicine for patients with a clinical diagnosis of early stage AD, who are confirmed positive for A brain pathology. The proposed assessments of A brain pathology are to identify suitable candidates for treatment with aducanumab.

Description of Medical Condition

AD is an insidiously progressive neurodegenerative disorder that represents the most common form of dementia. Mild cognitive impairment in the presence of A brain pathology as determined by either A PET or CSF AD biomarkers is the earliest symptomatic phase prior to the onset of dementia in the AD severity continuum. Accurate clinical diagnosis can be difficult in early stage AD. A plaque deposition in the brain, and/or lowered CSF levels of A, are considered to be pathological hallmarks of AD and implicated in the pathophysiologic process underlying early AD progression. As such, in early stage AD, abnormal A levels can provide greater diagnostic certainty.

Reason for Application

New MBS item

Medical Service Type


Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1576 KB)
Application Form (Word 308 KB)

Consultation Survey

Consultation Survey (PDF 560 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1296 KB)
PICO Confirmation (Word 253 KB)

Assessment Report


Public Summary Document


Meetings for this Application


10 December 2020
15-16 April 2021