Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p312
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 312/476)
Character Range: 2837989–2847114

laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
                                                                                                                                            The treatment must be limited to a maximum duration of 48 weeks.
                                                                                                                                            Evidence of chronic hepatitis C infection (repeatedly anti‑HCV positive and HCV RNA positive) must be documented in the patient's medical records.
                                                                       C9603                                                                Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 9603
                                                                                                                                            Must be treated in an accredited treatment centre.
                                                                                                                                            Patient must be aged 18 years or older; AND
                                                                                                                                            Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child‑bearing age.
                                                                                                                                            Patient must have compensated liver disease; AND
                                                                                                                                            Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
                                                                                                                                            Patient must have a contraindication to ribavirin; AND
                                                                                                                                            The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
                                                                                                                                            The treatment must be limited to a maximum duration of 48 weeks.
                                                                                                                                            Evidence of chronic hepatitis C infection (repeatedly anti‑HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Pegvisomant                                                            C7087                                                                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 a PBS‑subsidised somatostatin analogue; AND
                                                                                                                                            The treatment must cease if IGF‑1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.
                                                                                                                                            Somatostatin analogues include octreotide, lanreotide and pasireotide
                                                                                                                                            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).
                                                                                                                                            In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of IGF‑1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application.
                                                                       C9041                                                                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 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