Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p58
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 58/381)
Character Range: 11875033–11884003

restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C11168              P11168         CN11168          Lenvatinib                                                                                                      Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 11168
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must not be suitable for transarterial chemoembolisation; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    Patient must have Child Pugh class A; AND
                                                                                                                                                                    The condition must be untreated with systemic therapy.  or
                                                                                                                                                                    Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following:
                                                                                                                                                                     (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.
C11310              P11310         CN11310          Esomeprazole                                                                                                    Complex gastro-oesophageal reflux disease (GORD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control
                                                    Lansoprazole                                                                                                    Must be treated by a gastroenterologist; or
                                                                                                                                                                    Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or
                                                    Omeprazole                                                                                                      Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; or
                                                                                                                                                                    Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes; AND
                                                    Pantoprazole                                                                                                    The treatment must be:
                                                                                                                                                                     (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND
                                                    Rabeprazole                                                                                                     Patient must must have symptoms inadequately controlled with each of:
                                                                                                                                                                     (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control.  or
                                                                                                                                                                    Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for:
                                                                                                                                                                     (2) maintenance treatment.  or
                                                                                                                                                                    Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for:
                                                                                                                                                                     (3) re-establishment of symptom control.  or
                                                                                                                                                                    Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for:
                                                                                                                                                                     (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.
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