New therapy PBS listed in advanced Parkinson’s disease

A new therapeutic option for advanced Parkinson’s disease, Vyalev (foslevodopa with foscarbidopa), is now listed on the Pharmaceutical Benefits Scheme (PBS).

With Parkinson’s now recognised as the fastest-growing neurological condition in the country – affecting up to 219,000 Australians and with 30 new cases diagnosed each day – the need for more tailored and responsive therapies is intensifying. The disease doesn’t just affect the elderly: 10% of those diagnosed are under 45, and nearly one in five are still of working age.

Dr Victor Fung, Professor of Neurology and Motor Control at the University of Sydney and Consultant Neurologist at Westmead, said “As Parkinson’s advances, people experience a range of disabling motor and non-motor symptoms and it can become increasingly complex and hard to manage. Having access to a range of treatments that respond to the needs of people at the different stages of their Parkinson’s journey is essential for ensuring the best possible quality of life.”

He stressed that device-assisted therapies, like Abbvie’s Vyalev – play a critical role when oral treatments fail to control symptoms.

“It’s important to recognise there is a learning curve in moving to a device-assisted treatment and health care professionals and people living with Parkinson’s need to work closely together throughout their journey with their illness. Providing ongoing education and support, setting clear treatment goals and expectations, and working in partnership to meet needs and optimise outcomes are key considerations, along with ensuring the treatment approach is personalised for the individual,” Dr Fung added.

In the pivotal Phase 3 M15-736 trial, the therapy delivered a statistically significant improvement in “on” time – where symptoms are well controlled without troublesome involuntary movements – compared with oral levodopa/carbidopa combination. Patients on Vyalev gained an average of 2.72 additional hours of quality “on” time during a 16-hour waking period, compared to just 0.97 hours for those in the control group (p=0.0083).

Professor Carolyn Sue, Chair of the National Parkinson’s Alliance, highlighted the real-life burden of advanced Parkinson’s.

“People with advanced Parkinson’s live with significant unpredictability and uncertainty every single day. As the condition progresses, they may become increasingly dependent on those around them to help manage daily living. This loss of autonomy can take a huge physical, mental and emotional toll.

“While there is no known cure for Parkinson’s at the moment, symptomatic control and regaining one’s sense of self are essential for improving quality of life. People living with Parkinson’s need access to a range of affordable treatments as their condition progresses and we are very pleased a new option is now available through the PBS,” she commented.

For Parkinson’s Australia CEO Olivia Nassaris, the listing is a win for consumer advocacy.

“Parkinson’s Australia has advocated for access to Vyalev in Australia to ensure people living with advanced Parkinson’s have a wider choice of treatments that can help improve daily living. Throughout this process consumer voices have been vital in helping decision makers understand the impacts of living with Parkinson’s,” said Nassaris.

Nathalie McNeil, General Manager of AbbVie Australia, said the PBS listing is part of a broader commitment to tackling the far-reaching consequences of the disease.

“Parkinson’s is unpredictable, disrupting the lives of not only the people living with it, but also their carers, family and community. AbbVie is fully committed to supporting the Parkinson’s community through investment in research and developing therapies aimed at assisting people navigating the progression of Parkinson’s,” said McNeil.

Vyalev 24-hour infusion, administered subcutaneously, is indicated for individuals with advanced idiopathic Parkinson’s disease experiencing severe motor fluctuations despite optimised oral medications.

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