Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p313
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 313/476)
Character Range: 2846570–2851983

not have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            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 a PBS‑subsidised somatostatin analogue.
                                                                                                                                            Somatostatin analogues include octreotide, lanreotide and pasireotide
                                                                                                                                            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.
                                                                                                                                            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.
                                                                                                                                            In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.
                                                                                                                                            Biochemical evidence of remission is defined as normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1).
                                                                                                                                            Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF‑1 levels measured every 4 to 6 weeks in order to maintain the serum IGF‑1 level within the age‑adjusted normal range based on the dosage recommendations in the TGA‑approved Product Information.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            a) two completed authority prescription forms ; and
                                                                                                                                            b) a completed Acromegaly Pegvisomant initial 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, the date and result 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