Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p173
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 173/381)
Character Range: 12649023–12663093

immunologist or a specialist allergist;
                                                                                                                                                                    Patient must be aged 12 years or older.
                                                                                                                                                                    For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate
                                                                                                                                                                    The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.
C12467              P12467         CN12467          Lanadelumab                                                                                                     Chronic treatment of hereditary angioedema Types 1 or 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)
                                                                                                                                                                    Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; AND
                                                                                                                                                                    The treatment must not be used in combination with a C1-esterase inhibitor concentrate; AND
                                                                                                                                                                    Must be treated by a clinical immunologist or a specialist allergist;
                                                                                                                                                                    Patient must be aged 12 years or older.
C12470              P12470         CN12470          Cetuximab                                                                                                       Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12470
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    The treatment must be in combination with PBS-subsidised encorafenib for this condition.
C12480              P12480         CN12480          Idelalisib                                                                                                      Refractory follicular B-cell non-Hodgkin's lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 12480
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C12483              P12483         CN12483          Cetuximab                                                                                                       Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12483
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The treatment must be in combination with PBS-subsidised encorafenib for this condition.
C12484              P12484         CN12484          Encorafenib                                                                                                     Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12484
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in combination with cetuximab; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
C12487              P12487         CN12487          Encorafenib                                                                                                     Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12487
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have BRAF V600 variant positive metastatic colorectal cancer; AND
                                                                                                                                                                    The treatment must be in combination with cetuximab; AND
                                                                                                                                                                    Patient must not have received prior treatment with cetuximab for this condition; or
                                                                                                                                                                    Patient must not have developed disease progression while receiving cetuximab for this condition; AND
                                                                                                                                                                    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