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

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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:

CD adult quick reference

FCD quick reference

CD paediatric quick reference

Applications completed on the database

First continuing applications

Current treatment for subsequent continuing applications

Contraindications to prior therapy for paediatric patients

Delayed assessment for paediatric 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

S85:

adalimumab

infliximab s.c.

upadacitinib

ustekinumab s.c.

vedolizumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

vedolizumab i.v.

Yes

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

Extended induction (additional dose at week 10)

Telephone

Electronic

S100:

vedolizumab i.v.

No

OPA

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

Yes

Extended induction (optional)

Weeks 12 to 24

Telephone

Electronic

S85:

upadacitinib

No

OPA

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

Yes

Change or recommencement after a break

(<5 years)

or

recommencement after a break (>5 years)

PB235 form

Written

S85:

adalimumab

infliximab s.c.

upadacitinib

ustekinumab s.c.

vedolizumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

vedolizumab i.v.

Yes

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

First continuing

PB088 form

Written

S85:

adalimumab

infliximab s.c.

upadacitinib

ustekinumab s.c.

vedolizumab s.c.

S100:

infliximab i.v.

vedolizumab i.v.

No

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

Subsequent continuing:

originator brands

PB088 form

Written

S85:

adalimumab

infliximab s.c.

upadacitinib

ustekinumab s.c.

vedolizumab s.c.

S100:

infliximab i.v.

vedolizumab i.v.

No

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

Yes

Demonstration of response

PB235 form

Written

S85:

adalimumab

infliximab s.c.

upadacitinib

ustekinumab s.c.

vedolizumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

vedolizumab i.v.

No

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

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

S85:

adalimumab

infliximab s.c.

ustekinumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

Yes

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

Change or recommencement after a break (<5 years)

PB236 form

Written

S85:

adalimumab

infliximab s.c.

ustekinumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

Yes

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

First continuing

PB093 form

Written

S85:

adalimumab

infliximab s.c.

ustekinumab s.c.

S100:

infliximab i.v.

No

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

Subsequent continuing:

originator brands

PB093 form

Written

S85:

adalimumab

infliximab s.c.

ustekinumab s.c.

S100:

infliximab i.v.

No

OPA

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

Yes

Demonstration of response

PB236 form

Written

S85:

adalimumab

infliximab s.c.

ustekinumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

No

Database

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)

No

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

Yes

First continuing

PB161 form

Written

Electronic

S85:

adalimumab

S100:

infliximab i.v.

No

OPA

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

Yes

Subsequent continuing

Streamlined

S85:

adalimumab

No

N/A

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

N/A

Subsequent continuing:

originator brands

PB161 form

Written

Electronic

S100:

infliximab i.v.

No

OPA

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

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:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

N/A

Balance of supply

(top-up)

Telephone

Electronic

S85:

adalimumab

S100:

infliximab i.v.

No

OPA

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • consultant physician (general medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

Yes

Applications completed on the database

Table 4: not applicable for paediatric patients as of 1 September 2025.

Application type

Action

Initial
  • Create a patient record on the database if needed
  • Create a new pended entry in the database
  • Send to a Pharmaceutical Advisor (PA) for assessment
  • Once PA has assessed application, complete the entry in the database

First continuing

If approved:

  • Create and complete an entry in the database
  • Enter the next assessment date (NAD)

Subsequent continuing
  • No line in the database needed
  • If approved, enter the NAD

Change or recommencement

  • Create a new pended entry in the database
  • Send to a PA for assessment
  • Once PA has assessed application, complete the entry in the database

Balance of supply
  • No database entry needed

First continuing applications

Table 5: not applicable for paediatric patients as of 1 September 2025.

Assess up to 12 weeks of treatments

Assess after 12 weeks of treatment

Assess between 8 and 16 weeks of treatment
  • Infliximab i.v. - CD adult and FCD patients
  • Upadacitinib - CD adult patients
  • Vedolizumab i.v. - CD adult patients
  • Adalimumab - CD adult and FCD patients
  • Ustekinumab - CD adult patients
  • Vedolizumab s.c. - CD adult patients
  • Ustekinumab - FCD adult patients

Current treatment for subsequent continuing applications

Table 6: not applicable for paediatric patients as of 1 September 2025.

Step

Action

1

Check previous assessment date

Is the previous next assessment date within 3 months of date of processing?

2

Check if application is subsequent continuing

Is the application a subsequent continuing for a drug with a biosimilar brand listing?

3

Check prescriber current treatment

Is the current treatment no more than 3 months old from the date of the application form?

4

Check dispensing history

Is there a dispensing in the last 3 months?

5

Check letter or note from the prescriber

Is there a letter or note from the prescriber about a break in treatment?

Contraindications to prior therapy for paediatric patients

Table 7: 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.

Prior therapy

Contraindication

prednisolone (or equivalent)
  • Uncontrolled infection
  • Known hypersensitivity to prednisone or prednisolone, or any of the excipients

azathioprine
  • Hypersensitivity to any of the ingredients
  • Hypersensitivity to 6-mercaptopurine
  • Patients with rheumatoid arthritis previously treated with alkylating agents
  • Pregnancy or planning pregnancy

6-mercaptopurine
  • Hypersensitivity to any of the ingredients
  • Pregnancy

methotrexate
  • Hypersensitivity
  • Pregnancy
  • Breastfeeding
  • Severe hepatic impairment
  • Severe renal impairment
  • Alcoholism or alcoholic liver disease
  • Overt or laboratory evidence of immunodeficiency syndromes
  • Bone marrow depression or pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia
  • Serious, acute or chronic infections
  • Peptic ulcer disease or ulcerative colitis
  • Concurrent vaccinations with live vaccines
  • Concomitant administration with retinoids such as acitretin

Delayed assessment for paediatric patients

Delayed assessment due to:

  • intolerance to prior therapies
  • drug name of steroid

Table 8: this table lists the details of what to check for the delayed assessment and common acronyms.

Service Officers to assess that free text is:

Examples

Outcome

Relevant to the question

  • Intolerances to prior therapies:
    • Heart condition
    • Worsened renal failure
    • Nausea and vomiting
    • Elevated or deranged etc. liver function test
    • Gastrointestinal toxicity
  • Common oral steroids to treat CD:
    • budesonide
    • prednisolone
    • prednisone

Approve

Random text
  • Happy Birthday
  • Patient did not want to take
  • Ikasditbn

Reject

Non-descriptive
  • Toxicity (no details)
  • Intolerance
  • Ineffective

Reject

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.