Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p142
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 142/161)
Character Range: 14545948–14552696

at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                   The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord.  or
                                                                                   Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
                                                                                   The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
                                                                                   Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
                                                                                   For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
C13726              P13726         CN13726          Pembrolizumab                  Relapsed or 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; AND
                                                                                   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         CN13727          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