Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p292
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 292/476)
Character Range: 2698510–2704901

Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.
                                                                       C15350                                                               Uncontrolled severe allergic asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by 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, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND
                                                                                                                                            Patient must have a duration of asthma of at least 1 year; AND
                                                                                                                                            Patient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND
                                                                                                                                            Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND
                                                                                                                                            Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND
                                                                                                                                            Patient must not receive more than 28 weeks of treatment under this restriction.
                                                                                                                                            Patient must be aged 6 to less than 12 years.
                                                                                                                                            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.
                                                                                                                                            Patient must be under the care of the same physician for at least 6 months.
                                                                                                                                            Optimised asthma therapy includes:
                                                                                                                                            (i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;
                                                                                                                                            AND
                                                                                                                                            (ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.
                                                                                                                                            If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in 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.
                                                                                                                                            The following initiation 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