Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p115
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 115/312)
Character Range: 16189626–16195594

or 6 months on optimal dose is yet to be achieved; 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 be titrating mavacamten treatment until optimal dose is achieved; OR
                                                                                                                           Patient must be continuing mavacamten treatment to reach at least 6 months on the optimal dose prior to assessing the response.
                                                                                                                           Must be treated by a cardiologist; OR
                                                                                                                           Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.
                                                                                                                           The assessment of response must be conducted after at least 6 months on optimal dose to determine the patient's eligibility for maintenance treatment. Where an assessment is not undertaken, the patient will not be eligible for ongoing treatment. This treatment phase listing intends to provide up to 36 weeks of treatment in 3 treatment courses.
                                                                                                                           For the purposes of this restriction, an adequate response to treatment is defined as: an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient.
C15189              P15189         CN15189          Mavacamten                                                             Symptomatic obstructive hypertrophic cardiomyopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           Subsequent continuing treatment - Maintenance treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; OR
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition under the grandfather arrangements if at least 6 months on optimal dose is achieved; 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 after at least 6 months on the optimal dose of mavacamten treatment defined as an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient.
                                                                                                                           Must be treated by a cardiologist; OR
                                                                                                                           Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.
C15190              P15190         CN15190