Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p298
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 298/476)
Character Range: 2731854–2738860

observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines for severe asthma 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 the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.
                                                                                                                                            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) details of prior optimised asthma drug therapy (dosage, date of commencement, duration of 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) the IgE result and date; and
                                                                                                                                            (e) Asthma Control Questionnaire (ACQ-5) score.
                                                                       C15870                                                               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 least 6 months; OR
                                                                                                                                            Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
                                                                                                                                            Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND
                                                                                                                                            Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND
                                                                                                                                            Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past