CAMZYOS (mavacamten)

CAMZYOS (mavacamten)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Coverage Criteria:

For diagnosis of obstructive hypertrophic cardiomyopathy (HCM):

• Dose does not exceed 15 mg per day; AND

• Patient is 18 years of age and older; AND

• Prescribed by or in consultation with a cardiologist; AND

• Diagnosis of obstructive hypertrophic cardiomyopathy (HCM); AND

• Documentation supporting ALL of the following:

  • New York Heart Association (NYHA) Class II or III symptoms (e.g., shortness of breath, chest pain)

  • Patient has left ventricular ejection fraction greater than or equal to 55%

  • Patient has valsalva left ventricular outflow tract (LVOT) peak gradient greater than or equal to 50 mmHg at rest or with provocation; AND

• Trial and failure, intolerance, or contraindication to ALL of the following at a maximally tolerated dose:

  • Non-vasodilating beta-blockers (e.g., bisoprolol, propranolol, metoprolol, labetalol, pindolol, atenolol)

  • Calcium channel blocker (e.g., verapamil, diltiazem)

  • Disopyramide

Reauthorization Criteria:

For diagnosis of obstructive hypertrophic cardiomyopathy (HCM):

• Dose does not exceed 15 mg per day; AND

• Documentation of positive clinical response to therapy (e.g., improved symptom relief); AND

• Documentation supporting the patient has a left ventricular ejection fraction greater than or equal to 50%

Coverage Duration:

 
•    Initial: 16 weeks
•    Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Patients must enroll in Camzyos REMS program

• Dosage must be individualized based on clinical status and echocardiographic assessment of patient response.  Refer to the Full Prescribing Information for instructions

  • Recommended starting dosing is 5 mg once daily; allowable subsequent doses with titration are 2.5, 5, 10, and 15 mg once daily

• Initiation or up-titration of Camzyos in patients with LVEF <55% is not recommended

• Patients may develop heart failure while taking Camzyos.  Regular LVEF and Valsalva left ventricular outflow tract (LVOT) gradient assessment is required for careful titration to achieve an appropriate target Valsalva LVOT gradient, while maintaining LVEF ≥ 50% and avoiding heart failure symptoms

• Contraindications:

  • Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors

  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

• Drug interactions:

  • Weak CYP2C19 inhibitors and moderate CYP3A4 inhibitors

  • Negative inotropes

Policy Updates:

•    11/15/2022 – New policy approved by P&T.

References:

1. Camzyos prescribing information. MyoKardia, Inc. Brisbane, CA. April 2022.
2. Ommen SR, Mital S, Burke MA, et al. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With Hypertrophic Cardiomyopathy. Circulation. 2020;142(25).
3. Bristol-Myers Squibb. A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy. clinicaltrials.gov. Published June 10, 2022. Accessed June 17, 2022.