Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p12
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 12/381)
Character Range: 11495992–11506932

be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
                                                                                                                                                                    The treatment must be limited to a maximum duration of 12 weeks.
                                                                                                                                                                    The application must include details of the prior treatment regimen containing an NS5A inhibitor.
                                                                                                                                                                    The application must include details of the prior treatment regimen containing an NS5A inhibitor.
C10250              P10250         CN10250          Tolvaptan                                                                                                       Autosomal dominant polycystic kidney disease (ADPKD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a nephrologist; AND
                                                                                                                                                                    Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2 at the initiation of treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.
                                                                                                                                                                    Rapidly progressing disease is defined as either of the following
                                                                                                                                                                    A decline in eGFR of greater than or equal to 5 mL/min/1.73 m2 within one year;
                                                                                                                                                                    OR
                                                                                                                                                                    An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m2 per year over a five year period.
C10251              P10251         CN10251          Brivaracetam                                                                                                    Intractable partial epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10251
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a neurologist; AND
                                                                                                                                                                    The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND
                                                                                                                                                                    The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND
                                                                                                                                                                    Patient must be unable to take a solid dose form of this drug; AND
                                                                                                                                                                    The treatment must not be given concomitantly with levetiracetam, except for cross titration.
C10252              P10252         CN10252          Trifluridine with tipiracil                                                                                     Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10252
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have a WHO performance status of 1 or less; AND
                                                                                                                                                                    Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.
C10257              P10257         CN10257          Atezolizumab                                                                                                    Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 10257
                                                                                                                                                                    Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen
                                                                                                                                                                    Patient must have experienced