Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p258
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 258/476)
Character Range: 2441027–2448515

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. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                            Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.
                                                                                                                                            A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form; and
                                                                                                                                            (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            The following information must be provided at the time of application and must be documented in the patient's medical records:
                                                                                                                                            (a) if applicable, details of maintenance oral corticosteroid dose; and
                                                                                                                                            (b) a completed Asthma Control Questionnaire (ACQ-5) score.
                                                                       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.
                                                                       C15849                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment - Initial 2 (Change of treatment)
                                                                                                                                            Must be treated by a medical practitioner who