Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p143
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 143/191)
Character Range: 10983445–10995071

(PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); or
                                                                                                                                                                                                                               Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND
                                                                                                                                                                                                                               Patient must have previously failed an adequate trial of conventional therapy with cytarabine; or
                                                                                                                                                                                                                               Patient must have previously failed an adequate trial of conventional therapy with etoposide; or
                                                                                                                                                                                                                               Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum dose of 400 mg per day.
                                                                                                                                                                                                                               A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient's medical records.
C9278               P9278          CN9278           Imatinib                                                                                                                                                                   Gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9278
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND
                                                                                                                                                                                                                               Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
                                                                                                                                                                                                                               The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND
                                                                                                                                                                                                                               Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST.
C9286               P9286          CN9286           Deferiprone                                                                                                                                                                Iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9286
                                                                                                                                                                                                                               Patient must have thalassaemia major; AND
                                                                                                                                                                                                                               Patient must be unable to take desferrioxamine therapy.
C9287               P9287          CN9287           Doxorubicin - pegylated liposomal                                                                                                                                          Kaposi sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 9287
                                                                                                                                                                                                                               The condition must be AIDS-related; AND
                                                                                                                                                                                                                               Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
                                                                                                                                                                                                                               The condition must include extensive mucocutaneous involvement.
C9288               P9288          CN9288           Octreotide                                                                                                                                                                 Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 9288
                                                                                                                                                                                                                               Patient must have achieved symptom control on octreotide immediate release injections; 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 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C9289               P9289          CN9289           Octreotide                                                                                                                                                                 Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9289
                                                                                                                                                                                                                               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