Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p3
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 3/162)
Character Range: 14667415–14674553

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.
C13938              P13938         CN13938          Donepezil                                            Mild to moderately severe Alzheimer disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 13938
                                                                                                         Continuing
                                                    Galantamine                                          Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND
                                                                                                         Patient must demonstrate a clinically meaningful response to the initial treatment; AND
                                                    Rivastigmine                                         The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                         Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.
                                                                                                         Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.
                                                                                                         Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.
                                                                                                         Clinically meaningful response to treatment is demonstrated in the following areas
                                                                                                         Patient's quality of life including but not limited to level of independence and happiness;
                                                                                                         Patient's cognitive function including but not limited to memory, recognition and interest in environment;
                                                                                                         Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour.
C13940              P13940         CN13940          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 9 or less; 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.
                                                                                                         A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below.
                                                                                                         Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the 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