Crohn's disease (CD) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051111

Item

Description

1

When a Paediatric CD patient turns 18 years of age, does the patient continue to be approved under the Paediatric CD item codes?

No. They should be approved under adult CD item codes to meet age restriction criteria.

2

When a Paediatric CD patient turns 18 years of age, can a continuing adult CD application be completed to transition them from Paediatric CD?

Yes. A continuing adult CD application should be completed. A change application is not required, unless the prescriber wishes to change the patient's biological medicine to an alternative one. The Online Pharmaceutical Benefits Scheme (PBS) Authorities system (OPA system) may reject these requests; however this can be overridden after performing a history check to make sure previous treatment was under the paediatric Crohn's disease program.

3

The prescriber provided a Paediatric CD application with a CDAI. Is this a rejection?

Yes. If the patient is aged 6-17 years with a baseline PCDAI they must be assessed for continuing therapy with a PCDAI. A CDAI assessment cannot be accepted until the patient turns 18 years of age.

4

No. CD and FCD programs are separate. To switch program, an initial application must be requested. Refer prescribers to a PA for enquiries.

5

Do all First Continuing requests need to complete 12 weeks of treatment?

No. Some medications only require assessment of up to 12 weeks. See Process > Table 4.

6

Is the extended induction required for upadacitinib before a first continuing can be approved?

No. This is optional. If responding, the patient can be approved for continuing directly after an initial, change or recommencement approval.

7

What is the maximum IV infliximab dose for Crohn's and fistulising Crohn's disease?

The maximum PBS-subsidised dose that can be approved is 5mg/kg every 8 weeks after the initial loading dose.

8

Yes, as long as:

• the patient has met the relevant treatment criteria as specified in the initial, change or recommencement restriction for the IV formulation, and
• can provide a reason for the loading dose being omitted

9

Yes, as long as the patient has met the relevant treatment criteria as specified in the initial, change or recommencement restriction.

10

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:

• Balance of Supply - if the treatment phase (Initial, Change, Recommencement or Continuing) is yet to be completed; the following request is to be under the Continuing treatment
• Continuing treatment - if a treatment phase is concluding/has concluded and the prescriber has reassessed the patient for response

11

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:

• Balance of Supply - if the initial treatment phase is yet to be completed; the following request is to be under the Continuing treatment restriction, which is a streamline PBS authority item, or
• Continuing treatment - if a treatment phase is concluding/has concluded and/or an assessment of the patient has been completed. As of 1 November 2025, continuing treatment for the listed quantity and repeats are Authority Required (Streamlined)

12

No. Providing no more than 16 weeks of treatment has been requested, an IV dose is not mandatory. One repeat can be approved on a SC script for a dose at week 0 and 8 if requested.

13

Yes. If a prescriber submits an old application form and all Q+As can be answered in OPA, the request can be approved/rejected as appropriate. Refer any queries to a PA.

14

No, a 'medical break' can no longer be accepted as this is not supported by the restriction. Prescriber will need to document a demonstration of response in the patient's record.

15

The CD database is no longer available for staff. Refer all Release of information (ROI) queries to a PA.

16

Yes. Patients who were initiated on treatment as a paediatric patient (prior to 18 years of age) via non-PBS pathways (for example - compassionate access or public hospital individual patient use program), can transition to PBS-subsidised ongoing treatment under the restriction 'Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient'.

17

Yes. Providing all initial PBS criteria was met prior to commencement, patients can access ongoing treatment under the initial 2 adult restriction. Baseline measurements must be provided.