Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p305
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 305/476)
Character Range: 2773759–2786590

the survival motor neuron 1 (SMN1) gene; or
                                                                                                                                            (ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.
                                                                                                                                            Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).
                                                                                                                                            Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.
Pamidronic Acid                                                        C4433                                                                Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures – Streamlined Authority Code 4433
                                                                                                                                            Patient must have a malignancy refractory to anti‑neoplastic therapy
                                                                       C5218                                                                Multiple Myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 5218
                                                                       C5291                                                                Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 5291
                                                                                                                                            The condition must be due to breast cancer.
                                                                       C9234                                                                Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 9234
                                                                                                                                            Patient must have a malignancy refractory to anti‑neoplastic therapy.
                                                                       C9315                                                                Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9315
                                                                                                                                            The condition must be due to breast cancer.
                                                                       C9335                                                                Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9335
Pasireotide                                                            C9088                                                                Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must not have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have a mean growth hormone (GH) level greater than 1 microgram per litre or 3 mlU/L; OR
                                                                                                                                            Patient must have an age‑ and sex‑adjusted insulin‑like growth factor 1 (IGF‑1) concentration greater than the upper limit of normal (ULN); AND
                                                                                                                                            The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND
                                                                                                                                            The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of contraindication.
                                                                                                                                            If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
                                                                                                                                            Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:
                                                                                                                                            1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR
                                                                                                                                            2) IGF‑1 level is greater than the age‑ and sex‑adjusted ULN.
                                                                                                                                            In a patient treated with radiotherapy, pasireotide should be withdrawn