Psoriasis (PSOR) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051130

This document outlines details of PBS-subsidised biological medicines for patients with severe chronic plaque psoriasis (PSOR).

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 PB112 form	Written Electronic S85: adalimumab bimekizumab etanercept guselkumab infliximab s.c. ixekizumab risankizumab secukinumab tildrakizumab ustekinumab S100: infliximab i.v.	No	OPA	Must be treated by a: dermatologist	Yes - delayed assessment (due to PASI assessment attachment and any free text option used)
Change (<5 years) or recommencement (<5 years) PB263 form	Written Electronic S85: adalimumab bimekizumab etanercept guselkumab infliximab s.c. ixekizumab risankizumab secukinumab tildrakizumab ustekinumab S100: infliximab i.v.	No	OPA	Must be treated by a: dermatologist	Yes - immediate or delayed assessment (delayed if any free text option used)
Recommencement (>5 years) PB263 form	Written Electronic S85: adalimumab bimekizumab etanercept guselkumab infliximab s.c. ixekizumab risankizumab secukinumab tildrakizumab ustekinumab S100: infliximab i.v.	No	OPA	Must be treated by a: dermatologist	Yes
Continuing	Streamlined S85: infliximab s.c.	No	N/A	Must be treated by a: dermatologist	N/A
First continuing PB113 form	Written Electronic S85: adalimumab bimekizumab etanercept guselkumab ixekizumab risankizumab secukinumab tildrakizumab ustekinumab S100: infliximab i.v.	No	OPA	Must be treated by a: dermatologist	Yes
Subsequent continuing PB113 form	Written Electronic S85: adalimumab bimekizumab etanercept guselkumab ixekizumab risankizumab secukinumab tildrakizumab ustekinumab S100: infliximab i.v.	No	OPA	Must be treated by a: dermatologist	Yes
Subsequent continuing - biosimilar brand	Streamlined S85: adalimumab etanercept ustekinumab S100: infliximab i.v. (Telephone for increased quantities of infliximab i.v. for patients>100kg)	No	N/A	Must be treated by a: dermatologist	N/A
Balance of supply (top -up)	Telephone Electronic S85: adalimumab bimekizumab etanercept guselkumab infliximab s.c. ixekizumab risankizumab secukinumab tildrakizumab ustekinumab S100: infliximab i.v.	No	OPA	Must be treated by a: dermatologist	Yes

Psoriasis (PSOR) paediatric quick reference

Table 2: etanercept

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial	Telephone Electronic S85: etanercept	No	OPA	Must be treated by a: dermatologist	Yes
Change	Telephone Electronic S85: etanercept	No	OPA	Must be treated by a: dermatologist	Yes
Recommencement	Telephone Electronic S85: etanercept	No	OPA	Must be treated by a: dermatologist	Yes
Re-treatment	Telephone Electronic S85: etanercept	No	OPA	Must be treated by a: dermatologist	Yes
Balance of supply (top-up)	Telephone Electronic S85: etanercept	No	OPA	Must be treated by a: dermatologist	Yes
Completion of course	Streamlined S85: etanercept	No	N/A	Must be treated by a: dermatologist	N/A

Table 3: adalimumab and ustekinumab

Restrictions	Authority level and section	PA assessment	Processing system	Prescriber type	Prescriber self-serve
Initial PB320 form	Written Electronic S85: adalimumab ustekinumab	No	OPA	Must be treated by a: dermatologist	Yes - immediate or delayed assessment (delayed due to any free text option used)
Change or recommencement PB320 form	Written Electronic S85: adalimumab ustekinumab	No	OPA	Must be treated by a: dermatologist	Yes
First continuing PB319 form	Written Electronic S85: adalimumab ustekinumab	No	OPA	Must be treated by a: dermatologist	Yes
Subsequent continuing - all brands	Streamlined S85: adalimumab	No	N/A	Must be treated by a: dermatologist	N/A
Subsequent continuing - originator PB319 form	Written Electronic S85: ustekinumab	No	OPA	Must be treated by a: dermatologist	Yes
Subsequent continuing - biosimilar	Streamlined S85: ustekinumab	No	N/A	Must be treated by a: dermatologist	N/A
Balance of supply	Telephone Electronic S85: adalimumab Ustekinumab	No	OPA	Must be treated by a: dermatologist	Yes

Contraindication to prior therapy

Table 4: this table lists the details of contraindication to each prior systemic therapy according to the relevant Therapeutic Goods Administration (TGA) approved Product Information.

Escalate to a Pharmaceutical Adviser (PA) if not sure about the contraindication to phototherapy.

Prior therapy	Contraindication
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
ciclosporin	Hypersensitivity Uncontrolled hypertension Uncontrolled infection Primary or secondary immunodeficiency (excluding autoimmune diseases and selective IgA deficiency) Impaired renal function
acitretin	Pregnancy Women of childbearing potential Hypersensitivity to acitretin or other retinoids Breastfeeding Severely impaired liver or kidney function Chronic abnormally elevated blood lipid values Combined use with tetracycline Combined use with methotrexate Concomitant administration with vitamin A or other retinoids
apremilast	Hypersensitivity Pregnancy Breastfeeding
deucravacitinib	Hypersensitivity

Delayed assessment

Table 5: this table lists the details of what to check for the delayed assessment due to intolerance to prior therapy and common acronyms used.

Service Officers to assess that free text is:	Examples	Outcome
Relevant to the question	Hypersensitivity to any components of the formulation Gastrointestinal adverse reactions Nausea and vomiting LFT derangement	Approve
Random text	Happy Birthday Patient did not want to take Ikasditbn	Reject
Non-descriptive	Toxicity (no details) Ineffective Intolerance	Reject

Common acronyms

LFT - Liver function tests
GI toxicity - Gastrointestinal
N+V - Nausea and vomiting

Escalate to a Pharmaceutical Adviser (PA) by phone if not sure of the acronym used.

Operational Information

Psoriasis (PSOR) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051130

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