Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p18
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 18/162)
Character Range: 14751329–14758770

drug will be approved under this criterion.
C14000              P14000         CN14000          Memantine                                            Moderately severe Alzheimer disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                         Initial
                                                                                                         Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND
                                                                                                         The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
                                                                                                         The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                         The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14.
                                                                                                         Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction.
C14001              P14001         CN14001          Nivolumab                                            Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 14001
                                                                                                         Induction treatment
                                                                                                         The condition must not have previously been treated; AND
                                                                                                         Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either:
                                                                                                          (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND
                                                                                                         Patient must have a WHO performance status of 2 or less; AND
                                                                                                         The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
                                                                                                         Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
                                                                                                         The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C14002              P14002         CN14002          Ozanimod                                             Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Continuing treatment
                                                                                                         Must be treated by a gastroenterologist (code 87); or
                                                                                                         Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                         Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                         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 treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                         Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
                                                                                                         At the time of the authority application, medical practitioners