Crohn's disease (CD) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051111
Expand allCD and FCD restriction and item codes
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PBS CD and FCD restriction and item codes
Next assessment date (NAD) calculatorFAQs from Service Officers
Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.
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 request transition them from Paediatric CD? Yes. A continuing adult CD request can be used to transition patients to the adult CD program. If a biosimilar brand for the listed quantity and repeats is required, a streamline authority can be written. A change application is not required, unless the prescriber wishes to change the patient's targeted therapy to an alternative one. The Online Pharmaceutical Benefits Scheme (PBS) Authorities (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 request 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 response with a PCDAI. OPA will reject this request as a CDAI assessment cannot be accepted until the patient turns 18 years of age. |
4 | Can a patient with a baseline CDAI continue the same treatment using a fistula assessment? 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 for FCD 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 requested? 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 fistulising and adult Crohn’s disease? The maximum PBS-subsidised dose that can be approved is 5mg/kg every 8 weeks after the initial loading dose. This includes patients who have been on treatment under the paediatric program after they turn 18 years of age. |
8 | What is the maximum IV infliximab dose for paediatric Crohn’s disease? The maximum PBS-subsidised dose that can be approved is 10mg/kg every 4 weeks after the initial loading dose. The loading dose can be at 10mg/kg. |
9 | Can infliximab SC be requested without an IV load for CD (adult or paediatric) patients? Yes, as long as:
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10 | Can vedolizumab SC be requested without IV treatment for an initial, change or recommencement request? Yes, as long as the patient has met the relevant treatment criteria as specified in the initial, change or recommencement restriction. |
11 | Does a switch from vedolizumab IV to vedolizumab SC require a change of treatment request? 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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12 | Does a switch from infliximab IV to infliximab SC require a change of treatment request? 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:
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13 | Is an IV dose of ustekinumab required for an initial, change or recommencement of treatment request? 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. |
14 | Can an application form still be accepted for Crohn's disease? 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. |
15 | 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 record. |
16 | If a prescriber calls requesting information about a patient's baseline, failure or response, are we able to help? The CD database is no longer available for staff. Refer all Release of information (ROI) queries to a PA. |
17 | Can a patient transition from non-PBS supply of upadacitinib, ustekinumab or vedolizumab to ongoing PBS-subsidised treatment? 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'. |
18 | Can an adult or paediatric patient who has been on non-PBS supply (for example, from overseas, compassionate treatment, etc.) transition to ongoing PBS-subsidised treatment? Yes. Providing all initial PBS criteria was met prior to commencement, patients can access ongoing treatment under the initial 2 restriction. Baseline measurements must be provided. |