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

CD and FCD restriction and item codes

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$\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.png$ PBS CD and FCD restriction and item codes

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Contact details

PBS Complex Drugs Programs

Forms

Crohn's disease adult - initial authority application (PB087)

Crohn's disease adult - change, recommencement or demonstration of response authority application (PB235)

Crohn's disease adult - continuing authority application (PB088)

Crohn's disease paediatric - initial authority application (PB085)

Crohn's disease paediatric - change or recommencement authority application (PB239)

Crohn’s disease paediatric - continuing authority application (PB161)

Fistulising Crohn's disease - initial or recommencement (treatment break greater than 5 years) authority application (PB092)

Fistulising Crohn’s disease - change, recommencement (treatment break less than 5 years) or demonstration of response authority application (PB236)

Fistulising Crohn's disease - continuing authority application (PB093)

Services Australia website

Crohn's disease - adult patient

Crohn's disease - paediatric patient

Crohn's disease - fistulising Crohn’s disease

External websites

PBS schedule for Crohn's disease (adult patients)

PBS schedule for Crohn's disease (paediatric patients)

PBS schedule for Fistulising Crohn’s disease

FAQs from Service Officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item	Description
1	The prescriber did not provide a CD activity index (CDAI) at baseline for an adult CD patient, but the patient is meeting CDAI now. Is this ok? No, a response can only be assessed against the parameters provided at baseline. There are 8 possible baseline targets for adult CD indicated on the database: CDAI ≤ 150 Normalisation of platelet count ESR ≤ 25mm/hr CRP ≤ 15mg/L Normalisation of lactoferrin or calprotectin level Evidence of mucosal healing on diagnostic imaging Reversal of high faecal output Prevention of surgery / Total Parenteral Nutrition (TPN) Note: if multiple parameters are provided at baseline, response only needs to be shown on one.
2	When a Paediatric CD patient turns 18, 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.
3	When a Paediatric CD patient turns 18, can a continuing adult CD application be submitted for them transferring from Paediatric CD? Yes. A continuing adult CD application should be provided. A change application form is not required, unless the prescriber wishes to change the patient’s biological medicine to an alternative one.
4	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.
5	The prescriber provided an adult CD application with a PCDAI. Is this a rejection? Yes. Not all responses can be answered on a PCDAI for an adult patient. An adult CDAI assessment must be provided if the patient is 18 years or older.
6	Can a patient with a baseline CDAI continue the same treatment using a fistula assessment? No. CD and FCD programs are separate. To change to either program, an initial application form must be submitted. Refer prescribers to the Services Australia website for initial application forms or a PA for enquiries.
7	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 Tab Table 5 First Continuing Crohn's disease (CD) Program in Pharmaceutical Benefits Scheme (PBS).
8	Does the change from intravenous (IV) form to subcutaneous (SC) form of the same medication require a change application or an escalation to a PA? No. A change of form type is not considered a change of medication and can be done as continuing or balance of supply without an escalation to a PA.
9	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 first continuing directly after an initial, change or recommencement approval.
10	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.
11	Can the SC infliximab or vedolizumab be approved without IV treatment for an initial, change or recommencement request? No. SC treatment cannot be approved without a prior approval for an IV script.
12	If a patient takes a break in therapy of more than 5 years, do they have to trial the prior therapies again in order to recommence therapy? No, prior therapies do not need to be re-trialled. However, new baselines must be submitted.
13	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: 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 Continuing treatment if a treatment phase is concluding/has concluded and the prescriber has reassessed the patient for response
14	How many prescriptions are required for an initial/change/recommencement application for ustekinumab? Two prescriptions are needed. One for the IV loading, the second one for the SC balance.
15	There are symbols like >, <, ≥ or ≤ in Q&A and on application forms. What do these symbols stand for? > means ‘greater than’ < means ‘less than’ ≥ is the combination of > and =; which means ‘greater than or equal to’ or ‘at least’ ≤ is the combination of < and =; which means ‘less than or equal to’, ‘up to’ or ‘at maximum’
16	Is the CD program going to be transformed as of 1 September 2025? Only CD for paediatric patients will be transformed as of 1 September 2025. CD adult and FCD are still assessed through written applications and database.
17	Without a database for paediatric patients, how are they assessed for response? The onus is on the prescriber to provide the correct assessment that shows a response to treatment as compared to the patient’s baselines which they must store in the patient’s medical records.
18	In terms of paediatric patients, can an older version of the form be accepted if all required information has been provided? Prescribers will need to use the most recent version of the form to allow all required Q&As to be answered. If the only Q&A that cannot be addressed is the timeframe, check the OPA approval/dispensing history. Escalate to PA if unsure.
19	Can a patient have a medical break in therapy? 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 records.
20	If a prescriber calls requesting information about a paediatric patient’s baseline, failure or response, are we able to help? The paediatric CD database will no longer be used for any application dated on or after 1 September 2025. It will remain as view only for a period of time; however, it will not be updated. Therefore, we cannot guarantee that we are providing the most up to date information to the prescriber. Refer to a PA if unsure.

Operational Information