Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p112
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 112/312)
Character Range: 16170149–16175928

due to hypertrophic cardiomyopathy; AND
                                                                                                                           Patient must have maximal end-diastolic left ventricular wall thickness which is at least one of either: (i) no less than 15 mm; (ii) no less than 13 mm if patient has familial hypertrophic cardiomyopathy (at least one first degree relative with a diagnosis of hypertrophic cardiomyopathy); AND
                                                                                                                           Patient must have confirmed peak left ventricular outflow tract (LVOT) gradient of no less than 50 mm Hg which is measured either: (i) at rest; (ii) after provocation with at least one of (a) Valsalva manoeuvre, (b) exercise; AND
                                                                                                                           Patient must have a current left ventricular ejection fraction (LVEF) of no less than 55%; AND
                                                                                                                           Patient must have had prior treatments with each of a (i) beta-blocker and (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND
                                                                                                                           Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND
                                                                                                                           Patient must be symptomatic with NYHA classes II or III.
                                                                                                                           Must be treated by a cardiologist; OR
                                                                                                                           Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           The authority application must be made in writing and must include all the following:
                                                                                                                           (1) A completed authority prescription form; and
                                                                                                                           (2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                           (3) The details of the echocardiogram and/ or cardiac magnetic resonance imaging (MRI) report confirming the diagnosis of hypertrophic cardiomyopathy (HCM). State all the following:
                                                                                                                           (a) the date, unique identifying number/code or provider number of the report;
                                                                                                                           (b) the left ventricular wall thickness in millimetres (mm).
                                                                                                                           (4) The details of a genotyping test report if the patient had been tested. State all the following:
                                                                                                                           (a) the date, unique identifying number/code or provider number of the report;
                                                                                                                           (b) if a gene has been identified that is associated with HCM;
                                                                                                                           (c) if any first-degree family relative has a confirmed diagnosis of HCM.
                                                                                                                           (5) The details of the LVOT gradient report. State all the following:
                                                                                                                           (a) the date, unique identifying number/code or provider number of the report;
                                                                                                                           (b) the measured LVOT gradient;
                                                                                                                           (c) how the LVOT gradient was measured (rest, Valsalva