Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p260
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 260/476)
Character Range: 2452553–2459275

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. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                            At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.
                                                                                                                                            A multidisciplinary severe asthma clinic team comprises of:
                                                                                                                                            (i) A respiratory physician; and
                                                                                                                                            (ii) A pharmacist, nurse or asthma educator.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) details of the proposed prescription; 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 must be provided at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
                                                                                                                                            (b) details (date and duration of treatment) of prior biological medicine treatment; and
                                                                                                                                            (c) eosinophil count and date; and
                                                                                                                                            (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and
                                                                                                                                            (e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
                                                                       C15873                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
                                                                                                                                            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 be under the care of the same physician for at least 6 months; OR
                                                                                                                                            Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
                                                                                                                                            Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
                                                                                                                                            Patient must have had a break in treatment of at least 12 months from the 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