Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p137
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 137/191)
Character Range: 10915611–10926805

break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions; AND
                                                                                                                                                                                                                               Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
C9204               P9204          CN9204           Imatinib                                                                                                                                                                   Aggressive systemic mastocytosis with eosinophilia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
                                                                                                                                                                                                                               Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; 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 pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a full blood examination report demonstrating eosinophilia must be documented in the patient's medical records.
                                                                                                                                                                                                                               The details of symptomatic organ involvement requiring treatment, including radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient's medical records.
C9206               P9206          CN9206           Imatinib                                                                                                                                                                   Aggressive systemic mastocytosis with eosinophilia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9206
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; 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.
C9209               P9209          CN9209           Imatinib                                                                                                                                                                   Dermatofibrosarcoma protuberans                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9209
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The condition must be unresectable; or
                                                                                                                                                                                                                               The condition must be locally recurrent; or
                                                                                                                                                                                                                               The condition must be metastatic; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have demonstrated a response to the PBS-subsidised treatment; 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