Subject: Specialty Quantity Limit Camzyos 5442-H P2024
Policy:
I. 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.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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FDA-recommended dosing
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Camzyos (mavacamten) 2.5 mg capsules
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30 per 30 days
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Initial: 5 mg once daily. Only initiate when LVEF ≥ 55%.
• Week 4:
° LVOT gradient < 20 mmHg: 2.5 mg once daily.
° LVOT gradient ≥ 20 mmHg: 5 mg once daily.
• Week 8:
• Currently taking 2.5 mg once daily:
§ LVOT gradient < 20 mmHg: Withhold drug and return at week 12.
§ LVOT gradient ≥ 20 mmHg: 2.5 mg once daily.
§ Currently taking 5 mg once daily:
§ LVOT gradient < 20 mmHg: 2.5 mg once daily.
§ LVOT gradient ≥ 20 mmHg: 5 mg once daily.
• Week 12:
° Currently withholding drug: 2.5 mg once daily if LVEF ≥ 50% and
recheck ECHO in 4 weeks. Maintain same dose for next 8 weeks
unless LVEF <50%.
° Currently taking 2.5 mg or 5 mg once daily: See maintenance
dosing.
Maintenance:
• LVEF < 50%: Interrupt treatment.
• LVEF 50-55% regardless of LVOT gradient, OR LVEF > 55% and LVOT
gradient < 30 mmHg: Maintain same dose.
• LVEF ≥ 55% and LVOT gradient ≥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 ≥ 50%, restart treatment at next lower daily (mg) dose level
(15 mg → 10 mg, 10 mg → 5 mg, 5 mg → 2.5 mg). If interrupted at 2.5
mg, restart at 2.5 mg.
• If LVEF < 50% twice on 2.5 mg daily, permanently discontinue
treatment.
Concomitant administration of weak CYP2C19 inhibitor or moderate
CYP3A4 inhibitor
• Reduce dosage by one level (15 mg → 10 mg, 10 mg → 5 mg, 5 mg →
2.5 mg).
• Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4
inhibitors in patients who are on stable treatment with 2.5 mg.
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Camzyos (mavacamten) 5 mg capsules
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30 per 30 days
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Camzyos (mavacamten) 10 mg capsules
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30 per 30 days
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Camzyos (mavacamten) 15 mg capsules
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30 per 30 days
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Abbreviations: LVEF: left ventricular ejection fraction; LVOT: left ventricular outflow tract; ECHO: echocardiography; CYP: cytochrome P450
Place of Service:
Outpatient
The above policy is based on the following references:
- Camzyos [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; June 2023.
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 30, 2024
