On November 1, 2023, significant changes will be implemented in the Pharmaceutical Benefits Scheme (PBS) regarding the authority requirements for certain biological and immunomodulator medicines used in the treatment of rheumatoid arthritis. This update aims to streamline the prescription process, making it more convenient for both prescribers and patients.
The changes primarily affect biosimilar medicines used for initial therapy. These will transition from “Authority Required (Written)” to “Authority Required (Telephone/Immediate online assessment).” Additionally, biosimilar medicines for first continuing therapy will shift to “Authority Required (Streamlined),” further simplifying the prescription process.
Furthermore, PBS listings for subsequent continuing therapy for the originator (or ‘reference’) brands of the affected medicines will also change from “Authority Required (Written)” to “Authority Required (Streamlined).”
The main objective behind these changes is to reduce administrative burdens for healthcare providers and enhance patient access to these vital treatments. Prescribers will no longer need to submit written applications for biosimilar medicines. Instead, they can seek approval through a telephone call or the Online PBS Authorities system, receiving immediate feedback on their requests.
Notably, prescribers will no longer require prior approval to prescribe continuing therapy with biosimilar medicines. This applies to both ‘first continuing’ and ‘subsequent continuing’ therapy listings. However, for originator brands where no biosimilar exists, prescribers will need to submit written applications for ‘first continuing’ therapy, while ‘subsequent continuing’ therapy listings will become streamlined.
In cases of switching between reference and biosimilar brands or between biosimilars of different biological medicines, prescribers must provide baseline disease severity indicators to enable real-time authority applications.
It’s important to note that the process for seeking authority to prescribe brands other than biosimilars as initial therapy remains unchanged, and PBS eligibility criteria for these medicines remain in place.
For pharmacists, all prescriptions written before November 1, 2023, remain valid, and they can continue dispensing as usual. Specific PBS item codes are being updated, so pharmacists should consult Table 1 for guidance on selecting the appropriate item code when dispensing prescriptions.
For patients, existing prescriptions remain valid, and there will be no disruption in the supply of medicines. The changes are aimed at promoting the use of biosimilar brands, which can lead to more affordable and accessible healthcare options for patients.
the upcoming PBS changes seek to simplify the prescription process for rheumatoid arthritis medicines, making it more efficient for prescribers, pharmacists, and patients while promoting the use of biosimilar brands to enhance affordability and access to essential treatments.
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