Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p147
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 147/191)
Character Range: 11025181–11036351

as monotherapy for this condition; AND
                                                                                                                                                                                                                               Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
                                                                                                                                                                                                                               Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
                                                                                                                                                                                                                               The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C9322               P9322          CN9322           Lipegfilgrastim                                                                                                                                                            Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9322
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                                                                                                               Patient must have had a prior episode of febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
C9328               P9328          CN9328           Zoledronic acid                                                                                                                                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9328
                                                                                                                                                                                                                               The condition must be due to breast cancer.
C9329               P9329          CN9329           Plerixafor                                                                                                                                                                 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.
C9334               P9334          CN9334           Botulinum toxin type A purified neurotoxin complex                                                                                                                         Moderate to severe spasticity of the lower limb following an acute event                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9334
                                                                                                                                                                                                                               Must be treated by a neurologist; or
                                                    Clostridium botulinum type A toxin - haemagglutinin complex                                                                                                                Must be treated by an orthopaedic surgeon; or
                                                                                                                                                                                                                               Must be treated by a rehabilitation specialist; or
                                                                                                                                                                                                                               Must be treated by a plastic surgeon; or
                                                                                                                                                                                                                               Must be treated by a geriatrician; AND
                                                                                                                                                                                                                               The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND
                                                                                                                                                                                                                               The treatment must only be used as second line therapy when standard management has failed; or
                                                                                                                                                                                                                               The treatment must only be used as an adjunct to physical therapy; AND
                                                                                                                                                                                                                               The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the