Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p87
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 87/191)
Character Range: 10495636–10507849

for this condition.
C7526               P7526          CN7526           Pralatrexate                                                                                                                                                               Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The condition must be relapsed or chemotherapy refractory; AND
                                                                                                                                                                                                                               Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition.
C7558               P7558          CN7558           Pralatrexate                                                                                                                                                               Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The condition must be relapsed or chemotherapy refractory; AND
                                                                                                                                                                                                                               Patient must have undergone appropriate prior front-line curative intent chemotherapy.
C7566               P7566          CN7566           Dexamethasone                                                                                                                                                              Non-infectious posterior segment uveitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                                                                                                                               Must be treated by an ophthalmologist or in consultation with an ophthalmologist; AND
                                                                                                                                                                                                                               Patient must have documented visual impairment defined as a best corrected visual acuity score of approximate Snellen equivalent 6/12 or worse in the eye proposed for treatment, secondary to vitreous haze or macular oedema; AND
                                                                                                                                                                                                                               Patient must have unilateral, asymmetric or bilateral flare-up where systemic treatment or further intensification of systemic treatment is not clinically indicated.
C7593               P7593          CN7593           Glecaprevir with pibrentasvir                                                                                                                                              Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
                                                                                                                                                                                                                               Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                                                                                                               The treatment must be limited to a maximum duration of 8 weeks.
C7613               P7613          CN7613           Afatinib                                                                                                                                                                   Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7613
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition;
                                                                                                                                                                                                                               Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.
C7615               P7615          CN7615           Glecaprevir with pibrentasvir                                                                                                                                              Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
                                                                                                                                                                                                                               Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                                                                                                               The treatment must be limited to a maximum duration of 12