Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p140
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 140/191)
Character Range: 10948575–10960745

(GIST); AND
                                                                                                                                                                                                                               Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
                                                                                                                                                                                                                               The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; 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).
                                                                                                                                                                                                                               High risk of recurrence is defined as
                                                                                                                                                                                                                               Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
                                                                                                                                                                                                                               Primary GIST greater than 10 cm with any mitotic rate; or
                                                                                                                                                                                                                               Primary GIST with a mitotic count of greater than 10/50 HPF.
                                                                                                                                                                                                                               A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient's medical records.
                                                                                                                                                                                                                               The pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection, which must not be more than 3 months prior to treatment initiation must be recorded in the patient's medical records.
C9240               P9240          CN9240           Imatinib                                                                                                                                                                   Dermatofibrosarcoma protuberans                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The condition must be unresectable; or
                                                                                                                                                                                                                               The condition must be locally recurrent; or
                                                                                                                                                                                                                               The condition must be metastatic; AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum dose of 800 mg per day.
                                                                                                                                                                                                                               Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient's medical records.
C9243               P9243          CN9243           Imatinib                                                                                                                                                                   Myelodysplastic or myeloproliferative disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 9243
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The condition must be PDGFRB fusion gene-positive; AND
                                                                                                                                                                                                                               Patient must have achieved and maintained a complete haematological response; AND
                                                                                                                                                                                                                               The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum dose of 400 mg per day.
                                                                                                                                                                                                                               A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.
C9247               P9247          CN9247           Pazopanib                                                                                                                                                                  Advanced (unresectable and/or metastatic) soft tissue sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9247
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                                                                               Patient must have received prior chemotherapy treatment including an anthracycline; AND
                                                                                                                                                                                                                               Patient must not have received prior 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;