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
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. Note: if an older version of the application form is used, the question 'will the patient receive more than 12 weeks of treatment under this restriction?' may not be addressed. The authority request can still be approved if the treatment does not exceed the maximum of 12 weeks. Escalate to a PA if not sure. |
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