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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 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

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

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

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

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

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

  • 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

Check previous assessment date + Read more ...

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

2

Check if application is subsequent continuing + Read more ...

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

3

Check prescriber current treatment + Read more ...

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

4

Check dispensing history + Read more ...

Is there a dispensing in the last 3 months?

5

Check letter or note from the prescriber + Read more ...

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