Subject: Specialty Quantity Limit Camzyos 5442-H P2025

Drug

CAMZYOS  (mavacamten)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Camzyos (mavacamten) 2.5 mg capsule	30 per 30 days
Camzyos (mavacamten) 5 mg capsule	30 per 30 days
Camzyos (mavacamten) 10 mg capsule	30 per 30 days
Camzyos (mavacamten) 15 mg capsule	30 per 30 days

FDA-recommended Dosing

Abbreviations: LVEF: left ventricular ejection fraction; LVOT: left ventricular outflow tract; CYP: cytochrome P450

Initial

5 mg once daily. Only initiate when LVEF greater than or equal to 55%.

• Week 4
  • Valsalva LVOT gradient less than 20 mmHg: Down-titrate to 2.5 mg once daily.
  • Valsalva LVOT gradient greater than or equal to 20 mmHg: Maintain at 5 mg once daily.
• Week 8
  • Currently taking 2.5 mg once daily:
    • Valsalva LVOT gradient less than 20 mmHg: Withhold drug and return at week 12.
    • Valsalva LVOT gradient greater than or equal to 20 mmHg: 2.5 mg once daily.
  • Currently taking 5 mg once daily:
    • Valsalva LVOT gradient less than 20 mmHg: 2.5 mg once daily.
    • Valsalva LVOT gradient greater than or equal to 20 mmHg: Maintain at 5 mg once daily.
  • Week 12
    • Currently withholding drug: Restart on 2.5 mg if LVEF greater than or equal to 50%. Maintain same dose for next 8 weeks unless LVEF less than 50%.
    • Currently taking 2.5 mg or 5 mg once daily: See maintenance dosing.

Maintenance

• LVEF less than 50%: Interrupt treatment.
• LVEF 50% to less than 55%: Maintain same dose.
• LVEF greater than or equal to 55% and Valsalva LVOT gradient less than 30 mmHg: Maintain same dose.
• LVEF greater than or equal to 55% and Valsalva LVOT gradient greater than or equal to 30 mmHg: Up titration to next higher daily (mg) dose level (2.5 mg → 5 mg, 5 mg → 10 mg, 10 mg → 15 mg).

Treatment interruption

• When LVEF greater than or equal to 50%, restart treatment at next lower daily (mg) dose level (15 mg → 10 mg, 10 mg → 5 mg, 5 mg →5 mg). If interrupted at 2.5 mg, restart at 2.5 mg.
• If LVEF less than 50% twice on 2.5 mg daily, permanently discontinue treatment.

Concomitant administration of weak to moderate CYP2C19 inhibitor or moderate to strong CYP3A4 inhibitor

• On stable therapy with moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor: Initiate at 2.5 mg once daily.
• Initiating a weak to moderate CYP2C19 or a moderate to strong CYP3A4 inhibitor: Reduce daily dosage by one level (15 mg → 10 mg, 10 mg → 5 mg, 5 mg →5 mg).
• Avoid initiation of concomitant weak to moderate CYP2C19 and moderate to strong CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg.
• For short-term use (e.g., 1 week), interrupt treatment for the duration of treatment with a weak to moderate inhibitor of CYP2C19 or a moderate strong inhibitor of CYP3A4.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Camzyos [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; April 2025 .

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 12, 2025