Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p158
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 158/312)
Character Range: 16450048–16456601

derived through germline or somatic mutation testing.
C15416              P15416         CN15416          Niraparib                                                              High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets
                                                                                                                           The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.
C15424              P15424         CN15424          Dupilumab                                                              Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)
                                                                                                                           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 not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR
                                                                                                                           Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND
                                                                                                                           Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR
                                                                                                                           Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND
                                                                                                                           Patient must have a duration of asthma of at least 1 year; AND
                                                                                                                           Patient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35