Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p13
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 13/20)
Character Range: 43809–46918

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. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.
              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 drug for this condition within the same treatment cycle.
              A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle.
              The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.
              There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.
              At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab 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) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and
              (b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according