Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p222
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 222/476)
Character Range: 2169458–2177809

mm per hour; or
                                                                                                                                            (b) a CRP measurement no greater than 10 mg per L; or
                                                                                                                                            (c) an ESR or CRP measurement reduced by at least 20% from baseline.
                                                                                                                                            Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                                            Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Interferon Gamma‑1b                                                    C6222                                                                Chronic granulomatous disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 6222
                                                                                                                                            Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.
                                                                       C9639                                                                Chronic granulomatous disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 9639
                                                                                                                                            Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.
Ivacaftor                                                              C15251                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment - New patient (gating mutations)
                                                                                                                                            Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
                                                                                                                                            Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
                                                                                                                                            Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction; AND
                                                                                                                                            The treatment must be given concomitantly with standard therapy for this condition.
                                                                                                                                            Patient must be aged 4 months or older.
                                                                                                                                            Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a