Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p10
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 10/381)
Character Range: 11473524–11486185

of physical (not psychological) injury to the patient; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must be ambulatory (without assistance or support);
                                                                                                                                                                    Patient must weigh 40 kg or less.
                                                                                                                                                                    Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C10199              P10199         CN10199          Teriflunomide                                                                                                   Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10199
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or
                                                                                                                                                                    The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not show continuing progression of disability while on treatment with this drug.
                                                                                                                                                                    Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C10206              P10206         CN10206          Atezolizumab                                                                                                    Extensive-stage small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10206
                                                                                                                                                                    Initial treatment
                                                    Durvalumab                                                                                                      The condition must be previously untreated; AND
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    The treatment must be in combination with etoposide and a platinum-based antineoplastic drug.
C10208              P10208         CN10208          Brivaracetam                                                                                                    Intractable partial epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10208
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not be given concomitantly with levetiracetam.
C10210              P10210         CN10210          Brivaracetam                                                                                                    Intractable partial epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10210
                                                                                                                                                                    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
                                                                                                                                                                    The treatment must not be given concomitantly with levetiracetam, except for cross titration.
C10212              P10212         CN10212          Trastuzumab                                                                                                     Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 10212
                                                                                                                                                                    3 weekly treatment regimen
                                                                                                                                                                    Patient must have undergone surgery (adjuvant) or be