Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p4
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 4/162)
Character Range: 14673978–14681604

patient belongs.
                                                                                                         Patients who qualify under this criterion are from 1 or more of the following groups
                                                                                                         (1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
                                                                                                         (2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
                                                                                                         (3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;
                                                                                                         (4) Intellectual (developmental or acquired) disability, eg Down's syndrome;
                                                                                                         (5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;
                                                                                                         (6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.
                                                                                                         Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction.
C13941              P13941         CN13941          Donepezil                                            Mild to moderately severe Alzheimer disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial
                                                    Galantamine                                          Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND
                                                                                                         The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND
                                                    Rivastigmine                                         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. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.
                                                                                                         Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction.
C13945              P13945         CN13945          Abiraterone                                          Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                         The treatment must be used in combination with a corticosteroid; AND
                                                                                                         The treatment must not be used in combination with chemotherapy; AND
                                                                                                         Patient must have a WHO performance status of 2 or less; AND
                                                                                                         The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of:
                                                                                                          (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND
                                                                                                         Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication).  or
                                                                                                         Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.
C13946              P13946         CN13946          Ozanimod                                             Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Continuing treatment - balance of supply
                                                                                                         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