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.

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 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)
Initial	Telephone Electronic S85: infliximab s.c.	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 (< 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
Change or recommencement after a break (< 5 years) or recommencement after a break (>5 years)	Telephone Electronic S85: infliximab s.c.	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: 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) 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 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

Contraindications to prior therapy for CD paediatric 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 paediatric 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.

Operational Information

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

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