Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p6
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 6/381)
Character Range: 11434261–11445102

kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND
                                                                                                                                                                    Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer.
C10130              P10130         CN10130          Dabrafenib                                                                                                      Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                    Trametinib                                                                                                      Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
                                                                                                                                                                    Patient must not have experienced disease recurrence; AND
                                                                                                                                                                    Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
C10138              P10138         CN10138          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10138
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    The treatment must be commenced in a hospital-based movement disorder clinic.
C10139              P10139         CN10139          Dimethyl fumarate                                                                                               Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10139
                                                                                                                                                                    Continuing 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 previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not show continuing progression of disability while on treatment with this drug.
                                                                                                                                                                    Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C10140              P10140         CN10140          Dimethyl fumarate                                                                                               Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10140
                                                                                                                                                                    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.