Limited coverage criteria – mavacamten

Generic name

mavacamten

Strength & form

2.5 mg/5 mg/10 mg/15 mg, capsules

Initial

For the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) class II to III in adults patients 18 years of age or older, when ALL the following criteria are met:

Documented left ventricular ejection fraction (LVEF) ≥ 55% at rest determined by echocardiography¹ 

AND

Left ventricle (LV) wall thickness ≥ 15 mm (or ≥ 13 mm with a family history of hypertrophic cardiomyopathy) 

AND

Left ventricular outflow obstruction (LVOT) peak gradient ≥ 50 mm Hg at rest, after Valsalva maneuver or post-exercise, as confirmed by echocardiography

AND

Patient must be receiving beta-blocker or calcium-channel blocker therapy and experience clinical deterioration in symptoms or echocardiography while receiving either of these treatments²

AND

Special Authority coverage is requested by a cardiologist

24 weeks

Renewal

For renewal of coverage, the cardiologist must document that the patient meets ALL of the following criteria:

• LVEF > 30%

AND

• Patient has not received SRT

AND

• Patient must not have had LVEF < 50% on two consecutive occasions while on a dose of 2.5 mg daily of mavacamten (as per dosing and discontinuation guidelines in the product monograph)

1 year