New PBS listings for Takeda and Janssen

Pharma News: Takeda and Janssen welcome greater access to life-changing medicine for Australians, effective 1 February 2021.

The PBS listing of Takeda’s Attention Deficit Hyperactivity Disorder (ADHD) drug, Vyvanse (lisdexamfetamine dimesilate), will be expanded to include the treatment of adults diagnosed after the age of 18. Vyvanse is the first long-acting stimulant to be listed on the PBS as a treatment option for these Australians.

ADHD affects approximately 800,000 Australians, including more than 530,000 adults. However, ADHD is frequently misunderstood and under-diagnosed.

According to Professor David Coghill, Professor of Child and Adolescent Psychiatry, University of Melbourne, “The PBS listing of Vyvanse is welcome news. There is a need for increased awareness of ADHD and its symptoms amongst all Australians, but particularly amongst adults who may have
considered it to be a childhood disorder. Those living with ADHD should speak to their healthcare provider about the most suitable treatments and support for them.”

Some symptoms of ADHD can be similar to those for anxiety, depression, bipolar disorder, autism spectrum disorder, obsessive compulsive disorder, post-traumatic stress disorder, personality disorders or other mental illnesses. Many adults are diagnosed upon recognising their symptoms following their child’s diagnosis of ADHD.

The economic impact of ADHD is significant. In 2019, the total social and economic costs of ADHD in Australia were estimated to be $20.42 billion, or $25,071 per patient. Productivity losses of ADHD associated with absenteeism, presenteeism, reduced workforce participation and premature mortality were estimated to be $9.98 billion, or $17,483 per patient.

“Today’s PBS listing is an exciting milestone for Takeda and reflects our long-term commitment to increasing access to treatment options for Australians living with ADHD. We have a proud record in ADHD and are committed to supporting this often under-diagnosed, heavily stigmatised, and misunderstood group of Australians.” said Dr Jan Twomey, Medical Director at Takeda.

“We would like to extend our thanks to all those involved in helping to make Vyvanse available to those diagnosed with ADHD after the age of 18 – including the many patients, patient organisations, medical experts, and the Australian Government.”

Around 20,000 patients accessed a comparable treatment for this condition and could benefit from this new treatment option. Without PBS subsidy, patients might pay more than $1,200 per year for treatment.

Janssen’s Uptravi (selexipag), a selective, prostacyclin IP receptor agonist, is PBS listed for the first time to treat Pulmonary Arterial Hypertension (PAH), for use in combination with existing PAH therapies.

It is estimated over 700 Australians could access Uptravi for PAH through the PBS each year. Without subsidy, patients might pay more than $41,000 per year to access this medicine.

This listing can provide some patients with improvement in daily activities and quality of life, as well as delaying the need for injectable treatments and reducing the risks associated with IV infusions.

Recently, Janssen announced the FDA submission for Uptravi as an injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy.