Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p294
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 294/476)
Character Range: 2708958–2715324

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 (ACQ-IA) score.
                                                                       C15352                                                               Uncontrolled severe allergic asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have a documented history of severe allergic asthma; AND
                                                                                                                                            Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.
                                                                                                                                            An adequate response to omalizumab treatment is defined as:
                                                                                                                                            (a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA 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 or ACQ-IA score from baseline, OR
                                                                                                                                            (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.
                                                                                                                                            A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.
                                                                                                                                            Where a response assessment is not undertaken and provided at the time of application, 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 quantity and number of repeats to provide for a continuing course of omalizumab 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), sufficient for 24 weeks of therapy.
                                                                                                                                            The following information must be provided at the