Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p63
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 63/381)
Character Range: 11920005–11927909

be squamous type non-small cell lung cancer (NSCLC); AND
                                                                                                                                                                    Patient must not have previously been treated for this condition in the metastatic setting; AND
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                                                                                                                                    The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND
                                                                                                                                                                    The treatment must be in combination with nivolumab.
                                                                                                                                                                    The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C11482              P11482         CN11482          Amino acid formula with vitamins and minerals without lysine and low in tryptophan                              Pyridoxine dependent epilepsy
                                                                                                                                                                    Patient must be managed on a low lysine diet for pyridoxine dependent epilepsy; AND
                                                                                                                                                                    The condition must be treated by or in consultation with a metabolic physician.
C11523              P11523         CN11523          Adalimumab                                                                                                      Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 11523
                                                                                                                                                                    Subsequent continuing treatment
                                                                                                                                                                    Must be treated by a rheumatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                                                    Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    An adequate response to treatment is defined as
                                                                                                                                                                    an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
                                                                                                                                                                    either of the following
                                                                                                                                                                    (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                                                                    (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%
                                                                                                                                                                    (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                                                    (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                                                                    The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                                                                                    The measurement of response to the prior course of therapy must have been conducted