Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p140
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 140/381)
Character Range: 12431008–12440742

cycle under the Initial 3 treatment restriction.
                                                                                                                                                                    If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C12123              P12123         CN12123          Adalimumab                                                                                                      Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment - balance of supply
                                                                                                                                                                    Must be treated by a rheumatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
C12138              P12138         CN12138          Obeticholic acid                                                                                                Primary biliary cholangitis (previously known as Primary biliary cirrhosis)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 12138
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a prescriber who is either:
                                                                                                                                                                     (i) a gastroenterologist, (ii) a hepatologist; 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
                                                                                                                                                                    Patient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of:
                                                                                                                                                                     (i) the 'Initial treatment' listing, (ii) 'Grandfather' arrangements; AND
                                                                                                                                                                    Patient must be undergoing concurrent treatment with ursodeoxycholic acid, following this authority application; or
                                                                                                                                                                    Patient must be undergoing treatment with this drug as monotherapy following this authority application, because combination treatment with ursodeoxycholic acid is not tolerated; AND
                                                                                                                                                                    Patient must have achieved an adequate response to this drug, defined as having at least one of:
                                                                                                                                                                     (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.
                                                                                                                                                                    The improvement in the qualifying laboratory reading(s) has/have been documented in the patient's medical records.
C12140              P12140         CN12140          Obeticholic acid                                                                                                Primary biliary cholangitis (previously known as Primary biliary cirrhosis)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Transitioning from non-PBS to PBS subsidised supply - Grandfather arrangements
                                                                                                                                                                    Must be treated by a prescriber who is either:
                                                                                                                                                                     (i) a gastroenterologist, (ii) a hepatologist; 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