Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p234
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 234/312)
Character Range: 16948589–16954589

respond to treatment with that previous biological medicine.
                                                                                                                           An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine 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 at around 28 weeks, 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 biological medicine.
                                                                                                                           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.
                                                                                                                           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 (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and
                                                                                                                           (c) if applicable, the 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) if applicable, the IgE result and date; and
                                                                                                                           (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
C15887              P15887         CN15887          Etrasimod                                                              Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in