Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p295
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 295/476)
Character Range: 2714932–2723604

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 time of application and must be documented in the patient's medical records:
                                                                                                                                            (a) If applicable, the baseline and maintenance oral corticosteroid dose; and
                                                                                                                                            (b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or
                                                                                                                                            (c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and
                                                                                                                                            (d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.
                                                                                                                                            The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.
                                                                       C15376                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                            Balance of supply
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                            The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR
                                                                                                                                            The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.
                                                                       C15403                                                               Uncontrolled severe allergic asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                            Balance of supply in a patient aged 6 to 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 have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.
                                                                       C15846                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial