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

This document outlines details of PBS-subsidised targeted therapies for patients with Crohn's disease (CD) and fistulising Crohn's disease (FCD).

For details on how to process a PBS Authority, see Processing Complex Authority Required Listings.

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial	Telephone 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
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 (<12 months) or recommencement after a break (>12 months)	Telephone 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
Transitioning from non-PBS therapy commenced as a paediatric patient	Telephone Electronic S85: vedolizumab s.c. upadacitinib ustekinumab s.c. 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
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
Continuing originator brands	Telephone 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
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	Telephone Electronic S85: adalimumab infliximab 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) paediatrician or a specialist paediatric gastroenterologist	Yes
Change or recommencement after a break (<12 months) or recommencement after a break (>12 months)	Telephone Electronic S85: adalimumab infliximab 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) paediatrician or a specialist paediatric gastroenterologist	Yes
Continuing	Streamlined S85: adalimumab infliximab s.c. S100: infliximab i.v.	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) - initial	Telephone Electronic S85: adalimumab infliximab 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) paediatrician or a specialist paediatric gastroenterologist	Yes

First continuing applications for FCD

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. - FCD patients	Adalimumab - FCD patients	Ustekinumab - FCD adult patients

Operational Information

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

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