Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p37
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 37/69)
Character Range: 450390–458331

Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 13726
                                                                                                                Initial treatment
                                                                                                                Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR
                                                                                                                Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND
                                                                                                                Patient must not have received prior treatment with a PD‑1 (programmed cell death‑1) inhibitor for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up to 6 repeat prescriptions; OR
                                                                                                                Patient must be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 3 repeat prescriptions.
C13727              P13727         Pembrolizumab                                                                Relapsed or refractory primary mediastinal B‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 13727
                                                                                                                Initial treatment
                                                                                                                The condition must be diagnosed as primary mediastinal B‑cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography ‑ computed tomography (PET‑CT) scan, (ii) PET scan, (iii) CT scan; AND
                                                                                                                Patient must have been treated with rituximab‑based chemotherapy for this condition; AND
                                                                                                                Patient must be experiencing relapsed/refractory disease; AND
                                                                                                                Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR
                                                                                                                Patient must have undergone an autologous stem cell transplant (ASCT); OR
                                                                                                                Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab‑based chemotherapy; AND
                                                                                                                Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up to 6 repeat prescriptions; OR
                                                                                                                Patient must be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 3 repeat prescriptions.
C13728              P13728         Pembrolizumab                                                                Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND
                                                                                                                Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death‑1 (PD‑1) inhibitor, (ii) a programmed cell death ligand‑1 (PD‑L1) inhibitor; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test.
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up to