Eisai’s PBAC withdrawal stalls MSAC evaluation of Alzheimer’s diagnostic

Pharma News: The evaluation of two diagnostic tests for detecting early-stage Alzheimer’s Disease, aimed at determining eligibility for PBS listing of Eisai’s Leqembi (lecanemab), has been delayed. The Medical Services Advisory Committee (MSAC) postponed the evaluation at its August meeting following the withdrawal of the company’s application from the July PBAC meeting.

Alzheimer’s Disease (AD) is a progressive, neurodegenerative disorder characterized by a continuous decline in cognition and behavioral disturbances, which eventually result in the inability to perform daily living activities. AD is the leading cause of dementia, accounting for 60-70% of all cases.

Dr Elizabeth Moore, President of the Royal Australian and New Zealand College of Psychiatrists (RANZCP), commented “The College is supportive of any reform that appropriately orients the system to positive health outcomes for the ageing population.”

However, she added, “The advantages of Leqembi (lecanemab) are limited as its effectiveness is less than that of cholinesterase inhibitors for mild to moderate dementia, with current subsidised medications delivering a modest effect.”

She emphasised the need to manage family and caregiver expectations regarding Leqembi’s effectiveness, highlighting the resources required to deliver the medication and its efficacy. She also raised concerns about potential adverse side effects, such as brain swelling and bleeding, and the availability of essential diagnostic imaging like PET scans and MRI, particularly in rural and remote areas, which could pose financial barriers for patients.

Currently, the diagnosis of AD in Australia is primarily based on clinical findings and brain scans using computerised tomography (CT) or magnetic resonance imaging (MRI). This clinical diagnostic approach, without PET or CSF evidence of brain amyloid, is only about 70% accurate in the mild cognitive impairment (MCI) and mild dementia phases compared to the “gold standard” neuropathology examination.

The two proposed medical services involve protein biomarker tests, Aß positron emission tomography (PET) and cerebrospinal fluid (CSF) analysis. Either test could be used to detect the presence of Aß pathology in patients with AD. A positive Aß PET scan or CSF biomarker test result would determine patient eligibility for Leqembi treatment.

Professor Amy Brodtmann, Dementia Australia Honorary Medical Advisor, said “This is the first step towards dementia disease-modifying treatments. I see it as similar to the early stages of developing a treatment for AIDS, where many promising drugs were developed, but it took years to refine them into an effective treatment. I think we are at a similar stage with the search for an effective dementia treatment.

“It’s the first chink in the armour of dementia, and we can continue to build on this to hopefully develop an effective treatment in the future.”

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.