Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p68
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 68/476)
Character Range: 1213315–1220295

patient completing their current treatment course, unless the patient is currently on a treatment break.
                                                                                                                                            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.
                                                                                                                                            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 600 mg as an initial dose, followed by 300 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) 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 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.
                                                                       C15425                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment - Initial 2 (Change of treatment)
                                                                                                                                            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