Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p233
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 233/312)
Character Range: 16943404–16948948

drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C15886              P15886         CN15886          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 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR
                                                                                                                           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 had a 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, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; 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 biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to 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