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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:

Crohn's disease (CD) adult quick reference

Fistulising Crohn's disease (FCD) quick reference

Crohn's disease (CD) paediatric quick reference

Applications completed on the database

First continuing applications

Current treatment for subsequent continuing applications

Crohn's disease (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

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

Grandfather

PB357 form

Written

S85:

upadacitinib

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

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

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

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

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.

upadacitinib

ustekinumab

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

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

Medical break

Written

S85:

adalimumab

infliximab s.c.

upadacitinib

ustekinumab

vedolizumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

vedolizumab i.v.

Yes

Database

Must be treated by a:

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

No

Fistulising Crohn's disease (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

Grandfather

PB092 form

Written

S85:

ustekinumab s.c.

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

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

Medical break

Written

S85:

adalimumab

infliximab s.c.

ustekinumab s.c.

S100:

infliximab i.v.

ustekinumab i.v.

Yes

Database

Must be treated by a:

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

No

Crohn's disease (CD) paediatric quick reference

Table 3

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB085 form

Written

S85:

adalimumab

S100:

infliximab 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)
  • paediatrician or a specialist paediatric gastroenterologist

No

Change or recommencement after a break (< 5 years)

or

recommencement after a break

(>5 years)

PB239 form

Written

S85:

adalimumab

S100:

infliximab 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)
  • paediatrician or a specialist paediatric gastroenterologist

No

First continuing

PB161 form

Written

S85:

adalimumab

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)
  • paediatrician or a specialist paediatric gastroenterologist

No

Subsequent continuing:

originator brands

PB161 form

Written

S85:

adalimumab

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)
  • paediatrician or a specialist paediatric gastroenterologist

No

Subsequent continuing:

biosimilar brands

Streamlined

S85:

adalimumab

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

Demonstration of response

PB239 form

Written

S85:

adalimumab

S100:

infliximab i.v.

No

Database

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

No

Medical break

Written

S85:

adalimumab

S100:

infliximab i.v.

Yes

Database

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

No

Applications completed on the database

Table 4

Application type

Action

Initial or Grandfather
  • 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

Demonstration of response
  • Create and complete a new entry in the database
  • Update the drug history

 

Medical break
  • Create a new pended entry in the database
  • Send to a PA to action

First continuing applications

Table 5

Assess up to 12 weeks of treatments

Assess after 12 weeks of treatment

Assess between 8 and 16 weeks of treatment
  • Infliximab i.v. (Remicade®/ Inflectra®/ Renflexis®) - CD adult, CD paediatric and FCD patients
  • Upadacitinib (Rinvoq®) - CD adult patients
  • Vedolizumab i.v. (Entyvio® i.v.) - CD adult patients
  • Adalimumab (Humira® & biosimilars) - CD adult, CD paediatric and FCD patients
  • Infliximab s.c. (Remsima®) with infliximab i.v. loading - CD adult and FCD patients
  • Ustekinumab (Stelara®) - CD adult patients
  • Vedolizumab s.c. (Entyvio® s.c.) - CD adult patients
  • Ustekinumab (Stelara®) - FCD adult patients

Current treatment for subsequent continuing applications

Table 6

Step

Action

1

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

2

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

3

Has the prescriber completed current treatment or supplied dates of most recent treatment course on the application form?

4

Check dispensing history. Is there a dispensing in the last 3 months?

5

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

  • Yes, refer to a Pharmaceutical Advisor (PA)
  • No, reject