PBS updates

Steqeyma (Ustekinumab)

ustekinumab 90 mg/mL injection, 1 mL syringe · INJECTION · PBS code 14943L

AUTHORITY_REQUIRED

• • First listed on the PBS: 2025-08-01.
• • Repeats: 1.
• • PBS program: GE.

Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe chronic plaque psoriasis

First continuing treatment (Whole body)

Must be treated by a dermatologist; AND

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND

Patient must have demonstrated an adequate response to treatment; AND

Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

An adequate response to treatment is defined as:

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The assessment of response to treatment must be provided in this application and documented in the patient's medical records.

The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe chronic plaque psoriasis

First continuing treatment (Face, hand, foot)

Must be treated by a dermatologist; AND

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

The treatment must be as systemic monotherapy; or

The treatment must be in combination with methotrexate; AND

Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND

Patient must have demonstrated an adequate response to treatment; AND

Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The assessment of response to treatment must be provided in this application and documented in the patient's medical records.

Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.

Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.