Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p15
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 15/381)
Character Range: 11528308–11542036

Authority Required procedures - Streamlined Authority Code 10324
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND
                                                                                                                                                                    Patient must be antiretroviral treatment naive; or
                                                                                                                                                                    Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND
                                                                                                                                                                    The treatment must not be in combination with ritonavir.
                                                                                                                                                                    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.
C10328              P10328         CN10328          Binimetinib                                                                                                     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10328
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.
C10330              P10330         CN10330          Brivaracetam                                                                                                    Intractable partial epileptic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 10330
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must be unable to take a solid dose form of this drug; AND
                                                                                                                                                                    The treatment must not be given concomitantly with levetiracetam.
C10355              P10355         CN10355          Sapropterin                                                                                                     Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a metabolic physician; or
                                                                                                                                                                    Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
                                                                                                                                                                    Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.
                                                                                                                                                                    Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
C10362              P10362         CN10362          Tenofovir                                                                                                       Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10362
                                                                                                                                                                    Patient must be in the third trimester of pregnancy; AND
                                                                                                                                                                    Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.
C10363              P10363         CN10363          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10363
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    The treatment must be commenced in a hospital-based movement disorder clinic; AND
                                                                                                                                                                    Patient must require continuous administration of levodopa without an overnight break.  or
                                                                                                                                                                    Patient must require a total daily dose of more than 2000 mg of levodopa.
C10375              P10375         CN10375          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10375
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    The treatment must be commenced in a hospital-based