Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p161
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 161/312)
Character Range: 16465438–16471394

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              P15425         CN15425          Dupilumab                                                              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 had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR
                                                                                                                           Patient must have each of: (i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, (ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND
                                                                                                                           Patient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND
                                                                                                                           Patient must not receive more than 32 weeks of treatment under this restriction; AND
                                                                                                                           The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.
                                                                                                                           Patient must be aged 12 years or older.
                                                                                                                           An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of