PBS News

1 December 2023 Changes to the PBS Listings of Medicines for the Treatment of Ankylosing Spondylitis

Page last updated: 1 December 2023

On 1 December 2023, changes will be made to the authority requirements of the following biological medicines listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of ankylosing spondylitis – adalimumab, etanercept and infliximab.

From this date, the PBS listings of biosimilar medicines for initial therapy will change from Authority Required (Written), to Authority Required (telephone/immediate online assessment). The PBS listings of biosimilar medicines for first continuing therapy will change to Authority Required (Streamlined). The intention of these changes is to ease the administrative burden for prescribers and facilitate patient access to these treatments.

Why are these changes happening?

For information about the Pharmaceutical Benefits Advisory Committee’s (PBAC) recommendations that are leading to these changes, please read the outcome statement from the March 2022 meeting, available on the PBS website.

Information for prescribers

What is changing?

From 1 December 2023, if you wish to prescribe a biosimilar medicine for your eligible patients, you no longer have to apply in writing to Services Australia. You will be able to seek approval to prescribe a biosimilar medicine for initial therapy, either via telephone or by using Services Australia’s Online PBS Authorities system (OPA). You will receive an immediate outcome for your request. Once your patient’s eligibility is confirmed, they can leave the appointment with their prescription. This includes prescriptions for changes in therapy or recommencing treatment after a break.

You will no longer need to seek prior approval from Services Australia to prescribe first continuing therapy with a biosimilar medicine (for your eligible patients). Both the ‘first continuing’ and ‘subsequent continuing’ therapy listings for these medicines are now Authority Required (Streamlined).

Please note, 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 biological or immunomodulator medicine. 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. You may reuse the last set of indicators or provide a new baseline if you choose to.

What has not changed?

The PBS eligibility criteria for biological and immunomodulator medicines used to treat ankylosing spondylitis have not changed.  However, some of the wording in the PBS listings may have changed because of the changes to authority type for biosimilar medicines.

The process for seeking authority to prescribe brands (other than biosimilars) has not changed. Your patient also still has the option to receive a biosimilar brand, provided that when you are applying in writing to Services Australia, you allow brand substitution on the prescription or when selecting the medicine in your prescribing software. Pharmacists can continue to substitute a reference brand with a biosimilar brand.

When prescribing continuing therapy using the Authority Required (Streamlined) listings for biosimilar medicines, your patient must still meet all of the continuing therapy eligibility requirements.

Evidence of your patient’s eligibility (and continuing eligibility) must be documented in their medical record.

Information for pharmacists

All prescriptions written prior to 1 December 2023 remain valid. You may continue to dispense these as normal.

‘A’ Flagging

The changes to the authority requirements occurring on 1 December 2023 affect the substitution arrangements (‘a’ flagging) when substituting a biosimilar brand with a reference brand.  Note that pharmacists can continue to substitute a reference brand with a biosimilar brand.

Initial therapy - Where the prescription for a biosimilar has been approved by Services Australia via telephone or immediate online assessment, brand substitution with the reference brand is not permitted on these PBS item codes. Brand substitution with another biosimilar brand (if applicable) is permitted. Please select the PBS item code carefully.

First continuing and Subsequent continuing – where the prescription for a biosimilar is an Authority Required (Streamlined) prescription, brand substitution with the reference brand is not permitted on these PBS item codes. Brand substitution with another biosimilar brand (if applicable) is permitted.

Information for patients

Your current prescription remains valid. Your medicine will still be supplied as usual.  If you have any concerns, please talk to your doctor or pharmacist.

Biosimilar brands

The Australian Government has implemented policies to encourage greater use of biosimilar brands. Biosimilar medicines encourage market competition, which makes medicines more affordable. Because most medicines in Australia are subsidised, lower prices allow the Government to subsidise more medicines or spend more on other areas of health care. Biosimilar medicines give patients access to more brand options and can reduce the risk of medicine shortages. All Australian patients benefit from timely, equitable and sustainable access to safe and effective medicines through the PBS.

For further information on biosimilar brands please visit the Department of Health and Aged Care website. Information on the Government’s biosimilar uptake drivers is available on the PBS website.