Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p293
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 293/476)
Character Range: 2704515–2709661

criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:
                                                                                                                                            (a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),
                                                                                                                                            AND
                                                                                                                                            (b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.
                                                                                                                                            The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.
                                                                                                                                            This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with omalizumab.
                                                                                                                                            A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form; and
                                                                                                                                            (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            The following must be provided at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and
                                                                                                                                            (b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
                                                                                                                                            (c) the IgE result and date; and
                                                                                                                                            (d) Asthma Control Questionnaire (ACQ-5) score; or
                                                                                                                                            (e) Asthma Control Questionnaire interviewer administered version