Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p67
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 67/476)
Character Range: 1208652–1213712

E of at least 30 IU/mL, measured in the last 12 months that has 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 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:
                                                                                                                                            (i) 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;
                                                                                                                                            AND
                                                                                                                                            (ii) treatment with oral corticosteroids as outlined in the clinical criteria.
                                                                                                                                            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, 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) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.
                                                                                                                                            This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this