Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p133
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 133/381)
Character Range: 12384573–12393143

meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                    Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                    A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                                                                                                                    If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C12066              P12066         CN12066          Panitumumab                                                                                                     Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12066
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have RAS wild-type metastatic colorectal cancer; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    The condition must have failed to respond to first-line chemotherapy; or
                                                                                                                                                                    The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND
                                                                                                                                                                    The treatment must be as monotherapy; or
                                                                                                                                                                    The treatment must be in combination with chemotherapy; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.
                                                                                                                                                                    Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.
                                                                                                                                                                    Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.
C12084              P12084         CN12084          Obeticholic acid                                                                                                Primary biliary cholangitis (previously known as Primary biliary cirrhosis)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a prescriber who is either:
                                                                                                                                                                     (i) a gastroenterologist, (ii) a hepatologist; or
                                                                                                                                                                    Must be treated by a medical practitioner 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 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 experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least