Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p174
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 174/381)
Character Range: 12662520–12672656

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The condition must have failed to respond to at least one other line of systemic therapy; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less.
C12490              P12490         CN12490          Idelalisib                                                                                                      Refractory follicular B-cell non-Hodgkin's lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be refractory to a prior therapy with rituximab within 6 months after completion of treatment with rituximab; AND
                                                                                                                                                                    The condition must be refractory to a prior therapy with an alkylating agent within 6 months after completion of treatment with an alkylating agent; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    The condition is considered refractory to a prior therapy when the patient experiences less than a partial response or progression of disease within 6 months after completion of the prior therapy.
                                                                                                                                                                    The condition is considered refractory to both rituximab and an alkylating agent if the agents were administered together or in successive treatment regimens.
                                                                                                                                                                    The date of completion of prior therapies with rituximab and an alkylating agent must be documented in the patient's medical records.
C12491              P12491         CN12491          Idelalisib                                                                                                      Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for Chronic lymphocytic leukaemia; or
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for Small lymphocytic leukaemia; AND
                                                                                                                                                                    Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C12492              P12492         CN12492          Teriparatide                                                                                                    Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12492
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a specialist; or
                                                                                                                                                                    Must be treated by a consultant physician; AND
                                                                                                                                                                    Patient must be at very high risk of fracture; AND
                                                                                                                                                                    Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND
                                                                                                                                                                    Patient must have had 2 or more fractures due to minimal trauma; AND
                                                                                                                                                                    Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    The treatment must not exceed a lifetime maximum of 18 months therapy; AND
                                                                                                                                                                    Patient must not have received treatment with PBS-subsidised romosozumab.  or
                                                                                                                                                                    Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.
                                                                                                                                                                    A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these