Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p90
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 90/312)
Character Range: 16034230–16043460

treatment under both initial and continuing treatment restrictions, whichever comes first.
C15065              P15065         CN15065          Inclisiran                                                             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15065
                                                                                                                           Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; or
                                                                                                                           Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication.
C15068              P15068         CN15068          Methotrexate                                                           Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15068
                                                                                                                           Patient must be unsuitable for administration of an oral form of methotrexate for this condition.
C15070              P15070         CN15070          Lacosamide                                                             Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 15070
                                                                                                                           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 be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised anti-epileptic drug at the time the drug is/was first commenced.
C15071              P15071         CN15071          Golimumab                                                              Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have received prior 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 had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           Patient must have one or more of the following:
                                                                                                                            (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND
                                                                                                                           The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
                                                                                                                           The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society