Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p252
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 252/312)
Character Range: 17051591–17058421

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.
                                                                                                                           A multidisciplinary severe asthma clinic team comprises of:
                                                                                                                           (i) A respiratory physician; and
                                                                                                                           (ii) A pharmacist, nurse or asthma educator.
                                                                                                                           At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.
                                                                                                                           A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.
                                                                                                                           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) 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 to the relevant TGA-approved Product Information; and
                                                                                                                           (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
                                                                                                                           (d) Asthma Control Questionnaire (ACQ-5) score; and
                                                                                                                           (e) if applicable, the eosinophil count and date; and
                                                                                                                           (f) if applicable, the IgE result and date.
C15926              P15926         CN15926          Etrasimod                                                              Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - balance of supply
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                           The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
                                                                                                                           Must be treated by a gastroenterologist (code 87); OR
                                                                                                                           Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
                                                                                                                           Must be treated by a consultant physician [general medicine specialising