CSU restriction and item codes
Do not share this attachment externally. See Freedom of information - Information Publication Scheme.
PBS CSU restriction and item codes
Contact details
PBS Complex Drugs Programs
Forms
Severe chronic spontaneous urticaria - omalizumab - initial authority application form (PB223)
Services Australia website
Severe chronic spontaneous urticaria
External website
PBS schedule for omalizumab for severe chronic spontaneous urticaria
FAQs from Service Officers
Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.
Item | Description |
1 | Can an increase in quantity be approved if a higher dose is required? Yes. If the OPA system does not reject the quantity requested, an increase can be approved based on a higher monthly dose. If OPA rejects the quantity requested, escalate to a PA. |
2 | Can an increase in repeats be approved for an initial authority request? No. No more than 2 repeats can be approved for an initial authority request. The patient must not receive more than 12 weeks of initial treatment. |
3 | What type of application should be submitted for a patient who ceases therapy and relapses? Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient, meeting all initial PBS criteria again. |
4 | If a patient cannot be treated with H1 antihistamines due to contraindications and/or intolerances, must they still have experienced itch and hives that persist on a daily basis for at least 6 weeks to qualify for PBS‑subsidised CSU treatment, where all other criteria are met? Yes. The 6‑week duration of daily itch and hives is a mandatory clinical history requirement to determine the condition to be chronic and must be met in every case. |
Expand all