Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe chronic spontaneous urticaria

Initial treatment

Must be treated by a clinical immunologist; or

Must be treated by an allergist; or

Must be treated by a dermatologist; or

Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND

The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND

Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND

Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND

Patient must not receive more than 12 weeks of treatment under this restriction.

A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:

1) a H2 receptor antagonist (150 mg twice per day); or

2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or

3) doxepin (up to 25 mg three times a day)

If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.

A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.

The authority application must be made in writing and must include:

(a) details of the proposed prescription; and

(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application - Supporting Information Form which must include:

(i) demonstration of failure to achieve an adequate response to standard therapy; and

(ii) drug names and doses of standard therapies that the patient has failed; and

(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.