Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p171
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 171/381)
Character Range: 12630380–12640351

treatment continuity for those who meet the continuing restriction.
                                                                                                                                                                    Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
C12435              P12435         CN12435          Lanadelumab                                                                                                     Chronic treatment of hereditary angioedema Types 1 or 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    Continuing preventative treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not be PBS-subsidised in combination with a C1-esterase inhibitor concentrate; AND
                                                                                                                                                                    Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist;
                                                                                                                                                                    Patient must be aged 12 years or older.
                                                                                                                                                                    Patients who have successfully transitioned to a lower dosing frequency should be reviewed every 6 months to ensure they continue to demonstrate a sustained response
                                                                                                                                                                    For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.
C12440              P12440         CN12440          Ripretinib                                                                                                      Metastatic or unresectable malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must not be resectable; AND
                                                                                                                                                                    The treatment must be as monotherapy; AND
                                                                                                                                                                    The condition must have progressed despite treatment with all drugs PBS-listed specifically for this PBS-indication; or
                                                                                                                                                                    The condition must have progressed despite each of:
                                                                                                                                                                     (i) treatment with a drug PBS-listed specifically listed for this PBS-indication, (ii) an intolerance/expected intolerance to all other drugs PBS-listed for this specific PBS-indication; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    Patient must be undergoing PBS-subsidised treatment with this drug for the first time - retreatment/continuing treatment beyond the available repeat prescription is not permitted under this listing; see 'Continuing treatment' Treatment Phase listing to continue PBS-subsidised treatment in a patient without disease progression.
C12455              P12455         CN12455          Ripretinib                                                                                                      Metastatic or unresectable malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    The condition must not be resectable; AND
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be as monotherapy; AND
                                                                                                                                                                    Patient must not have developed