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Pharmaceutical Benefits Scheme Authority Requirements for Ankylosing Spondylitis Medicines Simplified

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On December 1, 2023, significant changes to the Pharmaceutical Benefits Scheme (PBS) will be implemented to the authority requirements for certain biological medicines used in the treatment of ankylosing spondylitis, a chronic inflammatory disease that primarily affects the spine and pelvis. This change specifically pertains to three key medicines: adalimumab, etanercept, and infliximab, which are listed on the Pharmaceutical Benefits Scheme.

These changes are driven by the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and are aimed at simplifying the process for both prescribers and patients. The goal is to reduce the administrative burden associated with these medications and improve patient access to treatments for ankylosing spondylitis.

Starting December 1, 2023, prescribers will no longer need to apply in writing to Services Australia when prescribing biosimilar medicines for initial therapy. Instead, they can seek approval through telephone or the Online Pharmaceutical Benefits Scheme Authorities system (OPA) and receive immediate outcomes for their requests. This change applies to both new therapy initiations and therapy resumptions after a break.

Updates to Authority Requirements for Ankylosing Spondylitis Medications

For the first continuing therapy with biosimilar medicines, the authority requirement will be streamlined, simplifying the process for prescribers. However, in certain cases, prescribers may need to provide baseline disease severity indicators to enable real-time assessment of authority applications.

While these changes simplify the process for biosimilar medicines, the eligibility criteria for biological and immunomodulator medicines for ankylosing spondylitis remain the same. Additionally, the process for seeking authority to prescribe non-biosimilar brands remains unchanged.

Pharmacists should be aware that prescriptions issued before December 1, 2023, will remain valid, and they can proceed with dispensing them in their routine manner. However, it’s crucial to take note that alterations in authority requirements will impact the arrangements for brand substitution, indicated by the “a” flagging, especially when substituting biosimilar brands with reference brands. Careful selection of the appropriate PBS item code is of paramount importance in this context.

Pharmaceutical Benefits Scheme

Seamless Medication Supply Continuity and the Advancement of Biosimilars through the Pharmaceutical Benefits Scheme

Patients holding existing prescriptions won’t need to fret, as their medication supply will continue without disruption. These modifications primarily simplify procedures for both prescribers and pharmacists, with the primary goal of enhancing patient accessibility to treatments for ankylosing spondylitis.

The Australian Government actively encourages the adoption of biosimilar brands as an integral part of its healthcare policy. Biosimilar medications play a pivotal role in fostering competition within the pharmaceutical market, consequently driving down medication costs and mitigating the risk of supply shortages. This approach is designed to benefit all patients across Australia by ensuring prompt, fair, and sustainable access to safe and efficacious medicines through the Pharmaceutical Benefits Scheme.


Resource: PBS, December 01, 2023

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