Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p183
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 183/312)
Character Range: 16606004–16615046

Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           The condition must not be acute promyelocytic leukaemia; AND
                                                                                                                           The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND
                                                                                                                           Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation; AND
                                                                                                                           The treatment must not be for maintenance therapy post-transplant.
                                                                                                                           The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.
C15527              P15527         CN15527          Nivolumab                                                              Urothelial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                           The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 120 days of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition; AND
                                                                                                                           Patient must have received prior platinum containing neoadjuvant chemotherapy; AND
                                                                                                                           Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.
                                                                                                                           Patient must be undergoing treatment with a dosing regimen as set out in the drug's Therapeutic Goods Administration (TGA) approved Product Information; AND
                                                                                                                           Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.
                                                                                                                           An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.
C15530              P15530         CN15530          Esomeprazole                                                           Gastro-oesophageal reflux disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 15530
                                                    Lansoprazole                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                    Omeprazole                                                             The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.
                                                    Pantoprazole
                                                    Rabeprazole
C15535              P15535         CN15535          Bisacodyl                                                              Terminal malignant neoplasia
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
                                                                                                                           Patient must identify as Aboriginal or Torres Strait Islander.
C15536              P15536         CN15536          Teriparatide                                                           Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with