Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p94
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 94/191)
Character Range: 10574234–10589129

PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be in combination with at least one anti-epileptic drug; AND
                                                                                                                                                                                                                               Patient must not be a candidate for curative surgery.
C8263               P8263          CN8263           Everolimus                                                                                                                                                                 Refractory seizures associated with tuberous sclerosis complex                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have a confirmed diagnosis of tuberous sclerosis complex (TSC); AND
                                                                                                                                                                                                                               Patient must be experiencing a minimum of two partial-onset seizures per week; AND
                                                                                                                                                                                                                               The condition must have failed to be controlled satisfactorily at stable doses of at least two anti-epileptic drugs; AND
                                                                                                                                                                                                                               The treatment must be in combination with at least one anti-epileptic drug; AND
                                                                                                                                                                                                                               Patient must not be a candidate for curative surgery;
                                                                                                                                                                                                                               Patient must be at least 2 years of age.
C8288               P8288          CN8288           Tolvaptan                                                                                                                                                                  Autosomal dominant polycystic kidney disease (ADPKD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 8288
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Must be treated by a nephrologist or in consultation with a nephrologist; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have end-stage renal disease defined as an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73m2; AND
                                                                                                                                                                                                                               Patient must not have had a kidney transplant.
C8326               P8326          CN8326           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 8326
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must be red blood cell transfusion dependent; AND
                                                                                                                                                                                                                               Patient must have a malignant disorder of haemopoieisis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.
C8328               P8328          CN8328           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 8328
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must be transfusion dependent; AND
                                                                                                                                                                                                                               Patient must not have a malignant disorder of erythropoiesis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.
C8329               P8329          CN8329           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 8329
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must not be transfusion dependent; AND
                                                                                                                                                                                                                               The condition must be thalassaemia; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.
C8544               P8544          CN8544           Guanfacine                                                                                                                                                                 Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 8544
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a paediatrician or psychiatrist; AND
                                                                                                                                                                                                                               The condition must be or have been diagnosed according to the DSM-5 criteria; AND
                                                                                                                                                                                                                               Patient must be receiving a maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine) which has been stable for at least four weeks; AND
                                                                                                                                                                                                                               The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine); AND
                                                                                                                                                                                                                               Patient must be experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning (social, academic or occupational), present in at least