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

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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

    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

    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

    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

    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

    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 the Background and Resources pages 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)

    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

    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

    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.