Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p141
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 141/191)
Character Range: 10959332–10973047

treatment with an angiogenesis inhibitor; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                                                                               Patient must not have any of the following conditions
                                                                                                                                                                                                                               adipocytic soft tissue sarcoma;
                                                                                                                                                                                                                               gastrointestinal stromal tumour (GIST);
                                                                                                                                                                                                                               rhabdomyosarcoma other than alveolar or pleomorphic;
                                                                                                                                                                                                                               chondrosarcoma;
                                                                                                                                                                                                                               osteosarcoma;
                                                                                                                                                                                                                               Ewings tumour/primitive neuroectodermal tumour;
                                                                                                                                                                                                                               dermofibromatosis sarcoma protuberans;
                                                                                                                                                                                                                               inflammatory myofibroblastic sarcoma;
                                                                                                                                                                                                                               malignant mesothelioma;
                                                                                                                                                                                                                               mixed mesodermal tumour of the uterus.
C9248               P9248          CN9248           Morphine                                                                                                                                                                   Chronic Breathlessness
                                                                                                                                                                                                                               Patient must be receiving palliative care.
C9252               P9252          CN9252           Nivolumab                                                                                                                                                                  Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9252
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                                                                               Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C9258               P9258          CN9258           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9258
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must be red blood cell transfusion dependent; AND
                                                                                                                                                                                                                               Patient must have a malignant disorder of haemopoieisis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.
C9260               P9260          CN9260           Lanreotide                                                                                                                                                                 Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9260
                                                                                                                                                                                                                               The condition must be causing intractable symptoms; AND
                                                                                                                                                                                                                               Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
                                                                                                                                                                                                                               Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
                                                                                                                                                                                                                               The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C9261               P9261          CN9261           Lanreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 9261
                                                                                                                                                                                                                               The condition must be active; AND
                                                                                                                                                                                                                               Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
                                                                                                                                                                                                                               The treatment must be after failure of other therapy including dopamine agonists; or
                                                                                                                                                                                                                               The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
                                                                                                                                                                                                                               The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
                                                                                                                                                                                                                               The treatment must cease in a patient treated with radiotherapy if there is biochemical