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Ulcerative colitis (UC) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051140



This document outlines details of PBS-subsidised biological medicines for patients with moderate to severe ulcerative colitis (UC).

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

On this page:

Ulcerative colitis (UC) adult quick reference

Ulcerative colitis (UC) paediatric quick reference

Delayed assessment

Ulcerative colitis (UC) adult quick reference

Table 1

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB127 form

Written

Electronic

S85:

adalimumab

etrasimod*

golimumab

infliximab s.c.

ozanimod

tofacitinib

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 free text field used)

Grandfather

PB376 form

Written

Electronic

S85:

etrasimod*

No

OPA

Must be treated by a:

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

Yes

Dose modification

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

Dose escalation

(initial/re-initiation)

Streamlined

S85:

ozanimod

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

etrasimod*

golimumab

infliximab s.c.

ozanimod

tofacitinib

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

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

Change or Recommencement after a break (<5 years)

PB245 form

Written

Electronic

S85:

Adalimumab

etrasimod*

golimumab

infliximab s.c.

ozanimod

tofacitinib

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 free text field used)

Recommencement after a break (>5 years)

PB245 form

Written

Electronic

S85:

Adalimumab

etrasimod*

golimumab

infliximab s.c.

ozanimod

tofacitinib

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

Balance of supply

Telephone

Electronic

S85:

adalimumab

etrasimod*

golimumab

infliximab s.c.

ozanimod

tofacitinib

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

Note: Patients under 18 can apply for etrasimod treatment using restrictions/application forms for adult patients. See: Treatment specifics and FAQs from Service Officers for more details.

Ulcerative colitis (UC) paediatric quick reference

Table 2

Restrictions

Authority level and section

PA assessment

Processing system

Prescriber type

Prescriber self-serve

Initial

PB215 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 -delayed assessment (delayed if free text field used)

Continuing - originator brands

Telephone

Electronic

S85:

adalimumab

S100:

infliximab i.v.

No

PA

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 - 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

Change or Recommencement after a break (<5 years)

PB246 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 free text field used)

Recommencement after a break (>5 years)

PB246 form

Written

Electronic

S85:

Adalimumab

S100:

infliximab i.v.

No

OPA

Must be treated by a:

  • gastroenterologist
  • consultant physician (internal medicine specialising in gastroenterology)
  • paediatrician or a specialist paediatric gastroenterologist

Yes

Balance of supply

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

Delayed assessment

Delayed assessment due to:

  • contraindication and/or intolerance to prior therapies
  • drug name(s) of prior therapies

Table 3: 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

  • Contraindications/intolerances to prior therapies:
    • Heart condition
    • Worsened renal failure
    • Nausea and vomiting
    • Elevated or deranged etc. liver function test
    • Gastrointestinal toxicity
  • Common 5-ASA to treat UC:
    • belsalazide
    • mesalazine
    • olsalazine
    • sulfasalazine
  • Common oral steroids to treat UC:
    • budesonide
    • prednisolone
    • prednisone
  • Common thiopurines to treat UC:
    • azathioprine
    • mercaptopurine
    • thioguanine

Approve

Random text

  • Happy Birthday
  • Patient did not want to take
  • Ikasditbn

Reject

Non-descriptive

  • Toxicity (no details)

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.