Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p290
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 290/476)
Character Range: 2687480–2694513

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) a completed authority prescription form; 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.
                                                                       C15347                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.
                                                                                                                                            Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
                                                                                                                                            Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Patient must be aged 12 years or older.
                                                                                                                                            An adequate response to omalizumab treatment is defined as:
                                                                                                                                            (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR
                                                                                                                                            (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score