Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p92
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 92/312)
Character Range: 16048847–16056804

beneficial by the treating clinician.
                                                                                                                           According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.
C15089              P15089         CN15089          Lacosamide                                                             Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 15089
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Must be treated by a neurologist; or
                                                                                                                           Must be treated by a paediatrician; or
                                                                                                                           Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
                                                                                                                           The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs prior to when the drug is/was first commenced; AND
                                                                                                                           The treatment must have been in combination with at least one PBS-subsidised anti-epileptic drug at the time the drug was first commenced.
C15094              P15094         CN15094          Cemiplimab                                                             Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 15094
                                                                                                                           Initial treatment - 3 weekly treatment regimen
                                                                                                                           Patient must not have previously been treated for this condition in the metastatic setting; or
                                                                                                                           The condition must have progressed after treatment with tepotinib; 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; AND
                                                                                                                           Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                           The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                                                                                           The treatment must not exceed a total of 7 doses under this restriction.
C15101              P15101         CN15101          Golimumab                                                              Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (New patient)
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND
                                                                                                                           Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an