Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p7
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 7/381)
Character Range: 11444499–11455681

preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must be ambulatory (without assistance or support).
                                                                                                                                                                    Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C10148              P10148         CN10148          Dabrafenib                                                                                                      Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                    Trametinib                                                                                                      The treatment must be adjuvant to complete surgical resection; AND
                                                                                                                                                                    The condition must be positive for a BRAF V600 mutation; AND
                                                                                                                                                                    Patient must have a WHO performance status of 1 or less; AND
                                                                                                                                                                    Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND
                                                                                                                                                                    Patient must not have received prior PBS-subsidised treatment for this condition; AND
                                                                                                                                                                    The treatment must commence within 12 weeks of complete resection; AND
                                                                                                                                                                    Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
C10150              P10150         CN10150          Teriflunomide                                                                                                   Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10150
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or
                                                                                                                                                                    The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must be ambulatory (without assistance or support).
                                                                                                                                                                    Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C10157              P10157         CN10157          Dabrafenib                                                                                                      Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10157
                                                                                                                                                                    Initial treatment
                                                    Vemurafenib                                                                                                     The condition must be positive for a BRAF V600 mutation; AND
                                                                                                                                                                    The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or
                                                                                                                                                                    Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
                                                                                                                                                                    Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less.
C10161              P10161         CN10161          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10161
                                                                                                                                                                    Patient must have