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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:

CD adult quick reference

FCD quick reference

CD paediatric quick reference

First continuing applications

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:

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

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:

  • 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

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:

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

Yes - immediate or delayed assessment (delayed if any attachments required)

Continuing

Streamlined

S85:

infliximab s.c.

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

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:

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

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:

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

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:

  • 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

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:

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

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:

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

Yes

Continuing

Streamlined

S85:

infliximab s.c.

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

First continuing

PB093 form

Written

Electronic

S85:

adalimumab

ustekinumab s.c.

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)

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:

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

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:

  • 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

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

First continuing applications

Table 4

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

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.

Prior therapy

Contraindication

prednisolone (or equivalent)

  • Uncontrolled infection
  • Known hypersensitivity to prednisone or prednisolone, or any of the excipients
  • Systemic or local bacterial, fungal or viral infections (applicable to adult patients only)
  • Hypersensitivity to any of the ingredients in budesonide (applicable to adult patients only)

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 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.

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.