Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p11
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 11/20)
Character Range: 37038–41138

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) 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 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).

          1.            omit:
   C15400     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 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