Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p2
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 2/162)
Character Range: 14662753–14667978

the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                         If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                         A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
                                                                                                         A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
                                                                                                         Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.
                                                                                                         Details of the accepted toxicities including severity can be found on the Services Australia website.
C13936              P13936         CN13936          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 9 or less; 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.
                                                                                                         A patient who is unable to register a score of 10 to 14 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 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)