Crohn's disease (CD) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051111
This document outlines details of PBS-subsidised biological medicines for patients with Crohn's disease (CD) and fistulising Crohn's disease (FCD).
For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.
On this page:
Contraindications to prior therapy for CD patients
Delayed assessment for CD patients
CD adult quick reference
Table 1
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial PB087 form | Written Electronic S85: adalimumab infliximab s.c. upadacitinib ustekinumab s.c. vedolizumab s.c. S100: infliximab i.v. ustekinumab i.v. vedolizumab i.v. | No | OPA | Must be treated by a:
| Yes - delayed assessment (due to free text option used and any attachments required) |
Extended induction (additional dose at week 10) | Telephone Electronic S100: vedolizumab i.v. | No | OPA | Must be treated by a:
| Yes |
Extended induction (optional) Weeks 12 to 24 | Telephone Electronic S85: upadacitinib | No | OPA | Must be treated by a:
| Yes |
Change or recommencement after a break (<5 years) or recommencement after a break (>5 years) PB235 form | Written Electronic S85: adalimumab infliximab s.c. upadacitinib ustekinumab s.c. vedolizumab s.c. S100: infliximab i.v. ustekinumab i.v. vedolizumab i.v. | No | OPA | Must be treated by a:
| Yes - immediate or delayed assessment (delayed if any attachments required) |
Continuing | Streamlined S85: infliximab s.c. | No | N/A | Must be treated by a:
| N/A |
First continuing PB088 form | Written Electronic S85: adalimumab upadacitinib ustekinumab s.c. vedolizumab s.c. S100: infliximab i.v. vedolizumab i.v. | No | OPA | Must be treated by a:
| Yes - immediate or delayed assessment (delayed if any attachments required) |
Subsequent continuing: originator brands PB088 form | Written Electronic S85: adalimumab upadacitinib ustekinumab s.c. vedolizumab s.c. S100: infliximab i.v. vedolizumab i.v. | No | OPA | Must be treated by a:
| Yes - immediate or delayed assessment (delayed if any attachments required) |
Subsequent continuing: biosimilar brands | Streamlined S85: adalimumab ustekinumab s.c. S100: infliximab i.v. (Telephone approval is required for quantity > 5) | No | N/A | Must be treated by a:
| N/A |
Balance of supply (top-up) | Telephone Electronic S85: adalimumab infliximab s.c. upadacitinib ustekinumab s.c. vedolizumab s.c. S100: infliximab i.v. vedolizumab i.v. | No | OPA | Must be treated by a:
| Yes |
FCD quick reference
Table 2
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial or recommencement after a break (>5 years) PB092 form | Written Electronic S85: adalimumab infliximab s.c. ustekinumab s.c. S100: infliximab i.v. ustekinumab i.v. | No | OPA | Must be treated by a:
| Yes |
Change or recommencement after a break (<5 years) PB236 form | Written Electronic S85: adalimumab infliximab s.c. ustekinumab s.c. S100: infliximab i.v. ustekinumab i.v. | No | OPA | Must be treated by a:
| Yes |
Continuing | Streamlined S85: infliximab s.c. | No | N/A | Must be treated by a:
| N/A |
First continuing PB093 form | Written Electronic S85: adalimumab ustekinumab s.c. S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes |
Subsequent continuing: originator brands PB093 form | Written Electronic S85: adalimumab ustekinumab s.c. S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes |
Subsequent continuing: biosimilar brands | Streamlined S85: adalimumab ustekinumab s.c. S100: infliximab i.v. (Telephone for increased quantities of infliximab i.v. for patients>100kg) | No | N/A | Must be treated by a:
| N/A |
Balance of supply (top-up) | Telephone Electronic S85: adalimumab Infliximab s.c. ustekinumab s.c. S100: infliximab i.v. ustekinumab i.v. | No | OPA | Must be treated by a:
| Yes |
CD paediatric quick reference
Table 3
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial PB085 form | Written Electronic S85: adalimumab S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes - immediate or delayed assessment (delayed if any free text option used) |
Change or recommencement after a break (< 5 years) or recommencement after a break (>5 years) PB239 form | Written Electronic S85: adalimumab S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes |
First continuing PB161 form | Written Electronic S85: adalimumab S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes |
Subsequent continuing | Streamlined S85: adalimumab | No | N/A | Must be treated by a:
| N/A |
Subsequent continuing: originator brands PB161 form | Written Electronic S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes |
Subsequent continuing: biosimilar brands | Streamlined S100: infliximab i.v. (Telephone for increased quantities of infliximab i.v. for patients >100kg) | No | N/A | Must be treated by a:
| N/A |
Balance of supply (top-up) | Telephone Electronic S85: adalimumab S100: infliximab i.v. | No | OPA | Must be treated by a:
| Yes |
First continuing applications
Table 4
Contraindications to prior therapy for CD patients
Table 5: this table lists the details of contraindications to each prior conventional drug according to the relevant Therapeutic Goods Administration (TGA) approved Product Information.
Escalate to a Pharmaceutical Adviser (PA) if unsure.
Delayed assessment for CD patients
Delayed assessment due to:
- intolerance to prior therapies
- drug name of steroid
Table 6: this table lists the details of what to check for the delayed assessment and common acronyms.
Common acronyms
- LFT - Liver function tests
- GI toxicity - Gastrointestinal
- N+V - Nausea and vomiting
Escalate to a Pharmaceutical Adviser (PA) by phone if unsure of the acronym and/or drug name used.