Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p70
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 70/381)
Character Range: 11968691–11978460

in consultation with a neurologist if treatment is being continued.  or
                                                                                                                                                                    Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.
C11644              P11644         CN11644          High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate                 Ketogenic diet
                                                                                                                                                                    Patient must have intractable seizures requiring treatment with a ketogenic diet; or
                                                                                                                                                                    Patient must have a glucose transport protein defect; or
                                                                                                                                                                    Patient must have pyruvate dehydrogenase deficiency; AND
                                                                                                                                                                    Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of:
                                                                                                                                                                     (i) a metabolic physician, (ii) a neurologist.
C11673              P11673         CN11673          Progesterone                                                                                                    Prevention of preterm birth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 11673
                                                                                                                                                                    Patient must have a singleton pregnancy; AND
                                                                                                                                                                    Patient must have at least one of:
                                                                                                                                                                     (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND
                                                                                                                                                                    The treatment must be administered no earlier than at 16 weeks gestation.
C11680              P11680         CN11680          Sacubitril with valsartan                                                                                       Chronic heart failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 11680
                                                                                                                                                                    Patient must be symptomatic with NYHA classes II, III or IV; AND
                                                                                                                                                                    Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
                                                                                                                                                                    Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker:
                                                                                                                                                                     (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta-blocker; AND
                                                                                                                                                                    Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or
                                                                                                                                                                    Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
                                                                                                                                                                    The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.
C11681              P11681         CN11681          Cannabidiol                                                                                                     Severe myoclonic epilepsy in infancy (Dravet syndrome)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                    Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND
                                                                                                                                                                    The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND
                                                                                                                                                                    Must be treated by a neurologist if treatment is being initiated.  or
                                                                                                                                                                    Must be treated by a neurologist if treatment is being continued or re-initiated.  or
                                                                                                                                                                    Must be treated by a paediatrician in consultation with a