Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p148
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 148/191)
Character Range: 11035910–11046292

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 Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND
                                                                                                                                                                                                                               Patient must not have established severe contracture in the limb to be treated; AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               Standard management includes physiotherapy and/or oral spasticity agents.
C9335               P9335          CN9335           Pamidronic acid                                                                                                                                                            Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9335

C9349               P9349          CN9349           Trastuzumab                                                                                                                                                                Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 9349
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                                                                                                                               Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required.
C9353               P9353          CN9353           Trastuzumab                                                                                                                                                                Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 9353
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
                                                                                                                                                                                                                               The treatment must not be in combination with nab-paclitaxel; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                                                                                                                               Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C9360               P9360          CN9360           Lapatinib                                                                                                                                                                  Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 9360
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be in combination with capecitabine; AND
                                                                                                                                                                                                                               Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic