Limited coverage drugs – mavacamten

Last updated on November 26, 2024

 

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Generic name

mavacamten

Strength & form

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

Special Authority criteria

Approval period

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

Practitioner exemptions

  • None

Special notes

  • 1At minimum, patients should have received an echocardiogram within six months prior to submitting a Special Authority request for initial treatment of mavacamten
  • 2Clinical deteriorations are defined as either worsening of symptoms or deterioration in outflow tract obstruction as demonstrated by an echocardiogram
  • Coverage will not be provided for patients who have had septal reduction therapy (SRT)
  • Mavacamten should be permanently discontinued if the patient has: 
    • LVEF ≤ 30%
    • Received SRT

Special Authority requests