Subject: Specialty Quantity Limit Camzyos 5442-H P2023
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
(HCM) fall within the standard limits. Coverage of an additional
quantity may be reviewed on a case-by-case basis upon request.
II. COVERED QUANTITIES
|
Medication
|
Standard Limit
|
FDA-recommended dosing
|
|
Camzyos
2.5 mg capsules
|
30 capsules
per 30 days
|
Initial: 5mg once daily. Only initiate when LVEF ≥ 55%
• Week 4:
º LVOT gradient < 20 mmHg: Down-titrate to
2.5mg once daily
º LVOT gradient ≥ 20 mmHg: Maintain at 5 mg
once daily
• Week 8:
º Currently taking 2.5mg once daily:
• LVOT gradient < 20 mmHg: Withhold drug
and return at week 12
• LVOT gradient ≥ 20 mmHg: 2.5mg once
daily
º Currently taking 5mg once daily:
• LVOT gradient < 20 mmHg: 2.5mg once
daily
• LVOT gradient ≥ 20 mmHg: Maintain at
5mg once daily
• Week 12:
º Currently withholding drug: Restart on 2.5mg if
LVEF ≥ 50% and recheck ECHO in 4 weeks.
Maintain same dose for next 8 weeks unless
LVEF <50%
º Currently taking 2.5mg or 5mg 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
(2.5mg → 5mg, 5mg → 10mg, 10mg → 15mg)
Treatment interruption:
• When LVEF ≥ 50%, restart treatment at next
lower daily (mg) dose level (15mg → 10 mg,
10mg → 5mg, 5mg → 2.5 mg). If interrupted at
2.5mg, restart at 2.5mg.
• 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 (15mg → 10 mg,
10mg → 5mg, 5mg → 2.5 mg)
• Avoid initiation of concomitant weak CYP2C19
and moderate CYP3A4 inhibitors in patients who
are on stable treatment with 2.5 mg.
|
|
Camzyos
5 mg capsules
|
30 capsules
per 30 days
|
|
Camzyos
10 mg capsules
|
30 capsules
per 30 days
|
|
Camzyos
15 mg capsules
|
30 capsules
per 30 days
|
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; September 2022.
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 15, 2023
