Subject: Camzyos 5268-A SGM P2022

Drug

CAMZYOS  (mavacamten)

Policy:

       I.  INDICATIONS

            The indications below including FDA-approved indications and
            compendial uses are considered a covered benefit provided
            that all the approval criteria are met and the member has no
            exclusions to the prescribed therapy.

            FDA-Approved Indications

            Camzyos is 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.

 
            All other indications are considered
            experimental/investigational and not medically necessary.

 
     II.  DOCUMENTATION
           Submission of the following information is necessary to initiate
           the prior authorization review:
           A.  Initial requests:
                1.  Chart notes or medical record documentation confirming
                     left ventricular wall thickness of greater than or equal to
                     15 mm, OR left ventricular wall thickness of greater than
                     or equal to 13 mm in members with familial hypertrophic
                     cardiomyopathy or in conjunction with a positive genetic
                     test (e.g., MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2,
                     MYL3, ACTC1 gene variants).
                2.  Chart notes or medical record documentation confirming
                     baseline LVEF is ≥ 55% and baseline Valsalva left
                     ventricular outflow tract (LVOT) peak gradient ≥ 50
                     mmHg.
           B.  Continuation requests:
                1.  Documentation (e.g., chart notes) that the member has
                     achieved or maintained a positive clinical response to
                     therapy (e.g., increase in pVO2, NYHA class reduction).
                2.  Documentation (e.g., chart notes) that left ventricular
                     ejection fraction (LVEF) is at or above the 50%
                     threshold.


   III.  CRITERIA FOR INITIAL APPROVAL

           Obstructive Hypertrophic cardiomyopathy
           Authorization of 3 months may be granted for treatment of
           obstructive hypertrophic cardiomyopathy when all of the
           following criteria are met:
           A.  Member has one of the following:
                1.  Left ventricular wall thickness of greater than or equal to
                     15 mm, OR
                2.  Left ventricular wall thickness of greater than or equal to
                     13 mm in members with familial hypertrophic
                     cardiomyopathy or in conjunction with a positive genetic
                     test (e.g., MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2,
                     MYL3, ACTC1 gene variants).
           B.  Member has NYHA class II-III symptoms.
           C.  Member must have a baseline left ventricular ejection
                fraction (LVEF) ≥ 55% and baseline Valsalva left ventricular
                outflow tract (LVOT) peak gradient ≥ 50 mmHg.

 
     IV.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for continued
            treatment in members requesting reauthorization for
            obstructive hypertrophic cardiomyopathy when all the of the
            following criteria are met:
            1.  The member achieves or maintains a positive clinical
                 response to therapy (e.g., increase in pVO2, NYHA class
                 reduction).
            2.  LVEF is at or above the 50% threshold.

 

      V.  APPENDIX

New York Heart Association (NYHA) Functional Classification³

NYHA Grading
Class I	No limitations of physical activity. Ordinary physical activity   does not cause undue fatigue, palpitation, dyspnea (shortness   of breath)
Class II	Slight limitation of physical activity. Comfortable at rest.   Ordinary physical activity results in fatigue, palpitation,   dyspnea (shortness of breath).
Class III	Marked limitation of physical activity. Comfortable at rest.   Less than ordinary activity causes fatigue, palpitation, or   dyspnea.
Class IV	Unable to carry on any physical activity without discomfort.   Symptoms of heart failure at rest. If any physical activity is   undertaken, discomfort increases.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Camzyos [package insert]. Brisbane, CA: Bristol Myers Squibb; April 2022.
2. Ommen, Steve R, et al. “2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.” Circulation, vol. 142, no. 25, 2020, pp. e558–e631., https://doi.org/10.1161/cir.0000000000000945. Accessed May 2, 2022.
3. “Classes of Heart Failure.” American Heart Association. 31 May 2017. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure. Accessed May 2, 2022.
4. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Cardiology Agents. May 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.

July 02, 2022