Janssen and Biogen therapies PBS listed in schizophrenia, SMA and MS

Pharma News: From 1 August 2022, Australians have access to new therapies through the Pharmaceutical Benefits Scheme (PBS), including Biogen’s spinal muscular atrophy and multiple sclerosis drugs, and Janssen’s schizophrenia therapy.

The PBS listing of Biogen’s Spinraza (nusinersen) will be extended to include treatment of adult patients diagnosed with spinal muscular atrophy (SMA) whose symptoms appeared before 19 years of age. 

Until now there have been no treatment options available on the PBS for adults living with SMA. Approximately one in 35 Australians carry the SMA gene, but most are unaware.

Professor Matthew Kiernan, Bushell Chair of Neurology at Royal Prince Alfred Hospital and Co-Director of the Brain and Mind Centre, University of Sydney said SMA has a significant impact on the day to day lives of adults with the disease.

“For adults with SMA this results in a loss of functional ability over time, with an increased risk of respiratory infections and increased hospital admissions. For many, it becomes a progressive battle against time to preserve quality of life and independence which can be distressing for themselves, their carers, and family members,” Professor Kiernan said.

Without a subsidy, families would pay well over $300,000 per year for nusinersen treatment. This will benefit an average of 100 patients per year. 

A new long-acting (6-month injection cycle) form of the medicine Janssen’s Invega Hafyera (paliperidone) will be listed to treat schizophrenia for patients who have been stabilised on 1-monthly or 3-monthly injections.  

“Long-acting injectable treatment offers an option for people living with schizophrenia, which enhances their compliance on medication, and hence lowers discontinuation and relapse rates, leading to a better quality of life for the patient and their families” said Dr Samir Ibrahim, Psychiatrist.

“The availability of a new treatment option on the PBS enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”

Schizophrenia is a complex brain disorder affecting between 150,000 and 200,000 Australians, causing an altered experience of reality including delusions and hallucinations.  

Without subsidy for paliperidone patients may pay $4,200 per year of treatment. Last year 5,400 people accessed another form of long-acting paliperidone, and they will now have an alternative treatment option.  

A new treatment option for those with multiple sclerosis (MS), Biogen’s Vumerity (diroximel fumarate) will be made available through the PBS. Without this listing patients could pay up to $8,500 a year on treatment. 

“Treatments for MS are selected according to their effectiveness, side effects and how well they fit in with people’s lives, and for those who prioritise flexibility and being able to adapt to life’s changing circumstances, the speed at which a therapy can be cleared from the body may be a factor that informs treatment decision-making,” said Dr Todd Hardy, leading Sydney Neurologist, based at Concord Hospital.

“This new medicine is a welcome addition to the treatment armamentarium for doctors like myself and brings hope for people with MS with another option available to them.”

Dr Julia Morahan, Head of Research at MS Australia, said “With the rate of MS seemingly on the rise in Australia4, having access to more treatments is welcome news for our community. This PBS listing is a significant milestone because it provides broad access for so many people who are already facing a challenging diagnosis. The economic cost of MS impacts not only those diagnosed, but also their families, carers and the broader community.”

David Henderson, General Manager of Biogen Australia and New Zealand, said “Today’s news provides an additional treatment option for people living with MS and represents another important milestone for Biogen in delivering on our ambition to improve the lives of those living with MS.

“Biogen’s foundations as a company, aiming through science to address the unmet needs of people living with challenging and complex diseases, has been built on its portfolio of MS products. From this, we have been able to support people across Australia, New Zealand and the rest of the world with a broad portfolio of MS therapies.”