Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p21
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 21/381)
Character Range: 11598787–11609632

10538
                                                                                                                                                                    Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND
                                                                                                                                                                    Must be treated by a respiratory physician.  or
                                                                                                                                                                    Must be treated by a paediatrician.
C10560              P10560         CN10560          Tocilizumab                                                                                                     Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                    Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - in a patient of any weight being administered a subcutaneous form of this biological medicine
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND
                                                                                                                                                                    Must be treated by a rheumatologist.  or
                                                                                                                                                                    Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
C10676              P10676         CN10676          Pembrolizumab                                                                                                   Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment - 6 weekly treatment regimen
                                                                                                                                                                    Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
                                                                                                                                                                    Patient must not have experienced disease recurrence; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.
C10688              P10688         CN10688          Pembrolizumab                                                                                                   Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - 6 weekly treatment regimen
                                                                                                                                                                    The treatment must be adjuvant to complete surgical resection; AND
                                                                                                                                                                    Patient must have a WHO performance status of 1 or less; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy 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.
C10701              P10701         CN10701          Pembrolizumab                                                                                                   Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10701
                                                                                                                                                                    Continuing treatment - 6 weekly treatment