Chronic spontaneous urticaria (CSU) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051109

This document outlines details of PBS-subsidised omalizumab for patients with severe chronic spontaneous urticaria (CSU).

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-service
Initial or Re-initiation PB223 form	Written Electronic S100: omalizumab (Any patient who ceases therapy and relapses will need to re-initiate as a new patient)	No	OPA	Must be treated by: a clinical immunologist an allergist a dermatologist a general physician with expertise in managing CSU	Yes - immediate or delayed assessment (delayed if any free text option used)
Continuing - originator	Telephone Electronic S100: omalizumab	No	OPA	Must be treated by: a clinical immunologist an allergist a dermatologist a general physician with expertise in managing CSU	Yes
Continuing - biosimilar	Streamlined S100: omalizumab	No	OPA	Must be treated by: a clinical immunologist an allergist a dermatologist a general physician with expertise in managing CSU	N/A

Delayed assessment

Delayed assessment due to:

Table 2: 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	A drug name Heart condition Worsened renal failure Nausea and vomiting Elevated or deranged etc. liver function test Gastrointestinal toxicity	Approve
Random text	Happy Birthday Patient did not want to take Ikasditbn	Reject
Non-descriptive	Grade 3 (no detail of toxicity) Toxicity	Reject

Common acronyms

Escalate to a Pharmaceutical Adviser (PA) by phone if unsure of the acronym used.

Operational Information