Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p127
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 127/381)
Character Range: 12343850–12353661

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. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C11985              P11985         CN11985          Nivolumab                                                                                                       Unresectable malignant mesothelioma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 11985
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    The treatment must be in combination with PBS-subsidised ipilimumab, unless an intolerance to ipilimumab of a severity necessitating permanent treatment withdrawal of ipilimumab; AND
                                                                                                                                                                    Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                                                                    The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
                                                                                                                                                                    The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C12016              P12016         CN12016          Cetuximab                                                                                                       Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 12016
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; or
                                                                                                                                                                    Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND
                                                                                                                                                                    Patient must not have progressive disease; 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 panitumumab are not eligible to receive PBS-subsidised cetuximab.
                                                                                                                                                                    Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.
C12029              P12029         CN12029          Eptinezumab                                                                                                     Chronic migraine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 12029
                                                                                                                                                                    Continuing treatment
                                                    Galcanezumab                                                                                                    Must be treated by a specialist neurologist or in consultation with a specialist neurologist; AND
                                                                                                                                                                    Patient must not be undergoing concurrent treatment with the following PBS benefits:
                                                                                                                                                                     (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND
                                                                                                                                                                    Patient must continue to be