Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p306
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 306/476)
Character Range: 2785930–2794553

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                                                          In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
                                                                                                                                            Biochemical evidence of remission is defined as:
                                                                                                                                            1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR
                                                                                                                                            2) normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1)
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            a) a completed authority prescription form; and
                                                                                                                                            b) a completed Acromegaly PBS Authority Application ‑ Supporting Information Form; and
                                                                                                                                            c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; the date and result of GH or IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and
                                                                                                                                            d) a recent result of GH or IGF‑1 levels must be provided.
                                                                       C9089                                                                Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
                                                                                                                                            Biochemical evidence of remission is defined as:
                                                                                                                                            1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR
                                                                                                                                            2) normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1)
                                                                                                                                            In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.
Patisiran                                                              C15453                                                               Hereditary transthyretin amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have either: (i) stage 1 polyneuropathy, (ii) stage 2 polyneuropathy.
                                                                                                                                            Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            The condition must be hereditary transthyretin amyloidosis confirmed by genetic testing; AND
                                                                                                                                            Patient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; OR
                                                                                                                                            Patient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; AND