Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p314
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 314/476)
Character Range: 2851485–2861003

of IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and
                                                                                                                                            d) a recent result of the IGF‑1 level and the date of assessment ; and
                                                                                                                                            e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide
                                                                                                                                            No increase in the maximum quantity or number of units may be authorised for the loading dose.
Plerixafor                                                             C4549                                                                Mobilisation of haematopoietic stem cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 4549
                                                                                                                                            The treatment must be in combination with granulocyte‑colony stimulating factor (G‑CSF); AND
                                                                                                                                            Patient must have lymphoma; OR
                                                                                                                                            Patient must have multiple myeloma; AND
                                                                                                                                            Patient must require autologous stem cell transplantation; AND
                                                                                                                                            Patient must have failed previous stem cell collection; OR
                                                                                                                                            Patient must be undergoing chemotherapy plus G‑CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
                                                                                                                                            Patient must be undergoing chemotherapy plus G‑CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
                                                                                                                                            Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records
                                                                       C9329                                                                Mobilisation of haematopoietic stem cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 9329
                                                                                                                                            The treatment must be in combination with granulocyte‑colony stimulating factor (G‑CSF); AND
                                                                                                                                            Patient must have lymphoma; OR
                                                                                                                                            Patient must have multiple myeloma; AND
                                                                                                                                            Patient must require autologous stem cell transplantation; AND
                                                                                                                                            Patient must have failed previous stem cell collection; OR
                                                                                                                                            Patient must be undergoing chemotherapy plus G‑CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
                                                                                                                                            Patient must be undergoing chemotherapy plus G‑CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
                                                                                                                                            Evidence that the patient meets the PBS restriction criteria must be recorded in the patient's medical records.
Pomalidomide                                                           C13746                                                               Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ dual therapy in combination with dexamethasone
                                                                                                                                            The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
                                                                                                                                            Patient must have undergone or be ineligible for a primary stem cell transplant; AND
                                                                                                                                            Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND
                                                                                                                                            Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information.
                                                                                                                                            Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with