Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p122
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 122/312)
Character Range: 16235079–16241296

left ventricular ejection fraction (LVEF) of no less than 55% prior to commencing non-PBS-subsidised treatment; AND
                                                                                                                           Patient must have had prior treatments with each of a (i) beta-blocker and (ii) non-dihydropyridine calcium channel blocker, unless contraindication/ intolerance present, prior to commencing non-PBS-subsidised treatment; AND
                                                                                                                           Patient must have been symptomatic with NYHA classes II or III prior to commencing non-PBS-subsidised treatment; 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 have a current left ventricular ejection fraction (LVEF) of no less than 50%; AND
                                                                                                                           Patient must have demonstrated a response if received the optimal dose of mavacamten treatment for at least 6 months, defined as an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) LVOT gradient; OR
                                                                                                                           Patient must be receiving mavacamten treatment but have not reached at least 6 months on optimal dose to demonstrate a response as defined above.
                                                                                                                           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 manoeuvre or exercise).
                                                                                                                           (6) NYHA status.
                                                                                                                           (7) The current beta-blocker or non-dihydropyridine calcium channel blocker (either diltiazem or verapamil only) therapy if applicable.
                                                                                                                           (8) Prior beta-blocker or non-dihydropyridine calcium channel blocker