UC restriction and item codes
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PBS UC restriction and item codes
PBS treatment and frequency codes
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PBS UC treatment and frequency codes
PBS Complex Drugs Programs
Services Australia website
FAQs from Service Officers
Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.
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Item |
Description |
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1 |
Is there an age restriction for patients applying for PBS-subsidised etrasimod to treat UC?
No. Patients of any age can apply for etrasimod. However, prescribers must apply using adult authority application forms for initial, change or recommencement or provide a partial mayo score for continuing treatment.
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2 |
Can we accept Paediatric Ulcerative Colitis Activity Index (PUCAI) scores for paediatric patients applying for etrasimod?
No. Although etrasimod does not have an age restriction, patients must meet the restriction criteria for adult patients and submit a Mayo or Partial Mayo clinic score with their authority applications. Escalate to a PA if the prescriber has provided PUCAI with a note in the application to explain why their patient could not be scored on adult markers.
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3 |
For an authority approval for vedolizumab, do we need to confirm if the patient has been appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy (PML)?
No. The PML assessment requirement for vedolizumab has been removed as of 1 October 2024.
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4 |
Does a switch from vedolizumab i.v. to vedolizumab s.c. require a change application?
No. Switching formulation is not considered a change of medication. Where there is already an approved authority prescription for the IV formulation, an authority application for the SC can be made under either:
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Balance of Supply if the treatment phase (Initial, First Continuing, or Subsequent Continuing) is yet to be completed; the following authority application is to be under the Continuing treatment.
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Continuing treatment if a treatment phase is concluding/has concluded and the prescriber has reassessed the patient for response.
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5 |
What is the maximum dose for infliximab i.v.?
5 mg/kg dosed every 8 weeks after the initial load
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6 |
Can infliximab 120 mg/mL syringe be approved for acute severe UC?
No. This formulation of infliximab can be approved only for moderate to severe UC.
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7 |
How many prescriptions are required for a change application to golimumab?
Two. One prescription for the loading dose and a second prescription for the maintenance/balance of initial treatment.
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8 |
What is the maximum dose for ustekinumab s.c.
90mg every 8 weeks after the initial IV load.
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9 |
How does a prescriber apply for ongoing infliximab i.v. after being treated for acute severe UC?
An initial PBS application form for moderate to severe UC must be submitted with a current partial mayo assessment. A continuing approval cannot be done by phone or by prescriber self-serve until the initial request has been approved.
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