Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p261
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 261/476)
Character Range: 2458837–2463757

most recently approved PBS-subsidised biological medicine for severe asthma; AND
                                                                                                                                            Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
                                                                                                                                            Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND
                                                                                                                                            Patient must have a duration of asthma of at least 1 year; AND
                                                                                                                                            Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR
                                                                                                                                            Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; 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 32 weeks of treatment under this restriction; AND
                                                                                                                                            The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
                                                                                                                                            Patient must be aged 12 years or older.
                                                                                                                                            Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.
                                                                                                                                            If the requirement for treatment with optimised asthma therapy 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.
                                                                                                                                            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, AND
                                                                                                                                            (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation,