Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p173
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 173/312)
Character Range: 16534395–16543122

must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy; AND
                                                                                                                           Patient must have a WHO performance status of no higher than 2; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have thyroid stimulating hormone adequately suppressed.
                                                                                                                           Radioactive iodine refractory is defined as:
                                                                                                                           (i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or
                                                                                                                           (ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or
                                                                                                                           (iii) progression within 12 months of a single RAI treatment; or
                                                                                                                           (iv) progression after two RAI treatments administered within 12 months of each other.
C15455              P15455         CN15455          Atezolizumab                                                           Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 15455
                                                                                                                           1,875 mg administered once every 3 weeks
                                                                                                                           Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR
                                                                                                                           Patient must be continuing existing PBS-subsidised treatment with this drug; OR
                                                                                                                           Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated.
                                                                                                                           Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.
                                                                                                                           The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND
                                                                                                                           The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND
                                                                                                                           The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
                                                                                                                           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.
C15456              P15456         CN15456          Midazolam                                                              Generalized convulsive status epilepticus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition.
C15457              P15457         CN15457          Midazolam                                                              Generalized convulsive status epilepticus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Patient must have been assessed to be at significant risk of status epilepticus; AND
                                                                                                                           Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency