Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p25
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 25/191)
Character Range: 9732380–9742922

Authority Required procedures - Streamlined Authority Code 5008
                                                                                                                                                                                                                               Patient must be infected with CCR5-tropic HIV-1; AND
                                                                                                                                                                                                                               The treatment must be in addition to optimised background therapy; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                                                                                                               Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
                                                                                                                                                                                                                               Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.
                                                                                                                                                                                                                               A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.
C5009               P5009          CN5009           Corifollitropin alfa                                                                                                                                                       Assisted Reproductive Technology                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 5009
                                                                                                                                                                                                                               The treatment must be for controlled ovarian stimulation; AND
                                                                                                                                                                                                                               Patient must have an antral follicle count of 20 or less; AND
                                                                                                                                                                                                                               Patient must be receiving medical services as described in items 13200, 13201, or 13202 of the Medicare Benefits Schedule; AND
                                                                                                                                                                                                                               Patient must be undergoing a gonadotrophin releasing antagonist cycle.
C5012               P5012          CN5012           Glycomacropeptide and essential amino acids with vitamins and minerals                                                                                                     Phenylketonuria

                                                    Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine

C5014               P5014          CN5014           Etravirine                                                                                                                                                                 HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5014
                                                                                                                                                                                                                               The treatment must be in addition to optimised background therapy; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                                                                                                               Patient must be antiretroviral experienced; AND
                                                                                                                                                                                                                               Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
                                                                                                                                                                                                                               Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.
C5015               P5015          CN5015           Clozapine                                                                                                                                                                  Schizophrenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5015
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND
                                                                                                                                                                                                                               Patient must be non-responsive to other neuroleptic agents.  or
                                                                                                                                                                                                                               Patient must be intolerant of other neuroleptic agents.
                                                                                                                                                                                                                               Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
                                                                                                                                                                                                                               The name of the consulting psychiatrist should be included in the patient's medical records.
                                                                                                                                                                                                                               A medical practitioner should request a quantity sufficient for up to one month's supply.