AS biosimilars script approval goes online

2 minute read


The latest change to prescribing requirements in rheumatology sees faster access to biosimilars for patients with ankylosing spondylitis.


The latest in the planned changes to prescribing requirements in rheumatology has taken effect, with faster scripts for some ankylosing spondylitis patients.

From 1 December 2023, PBS listings for adalimumab, etanercept and infliximab biosimilars for ankylosing spondylitis changed from Authority Required (Written) to Authority Required (telephone/immediate online assessment) for initial scripts.

The real-time assessment of authority requests is available through Services Australia’s Online PBS Authorities (OPA) system, via Health Professional Online Services (HPOS). Once their eligibility is approved, patients can leave the consultation with a prescription for their medicine.

The PBS points out you may need to provide Services Australia with baseline disease severity indicators when applying for authority approval to change your patient from one biological or immunomodulator medicine to a different one.

“This change in process is required to enable the real-time assessment of authority applications for biosimilar medicines to be made and approved through the OPA system. Each authority application is assessed based on the evidence of eligibility you provide for comparison against the PBS restriction criteria,” said the PBS, adding that you can choose to reuse the last set of indicators or provide a new baseline.

For first continuing scripts, the listing will change to Authority Required (Streamlined).

Originator brands remain Authority Required (Written) for initial and first continuing scripts, and have changed to Authority Required (Streamlined) for subsequent continuing scripts.

For more information, click here for changes to PBS listings for ankylosing spondylitis.

In making the prescription of biosimilars less burdensome, the government hopes to encourage greater use of them, making medicines more affordable, allowing greater access and potentially reducing the risk of medicine shortages.

The initiative is part of the Department of Health and Aged Care’s digital transformation of Authority Required (Written) PBS listings and follows changes to authority listings for giant cell arteritis, juvenile idiopathic arthritis and rheumatoid arthritis prescriptions earlier this year.

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