Subject: Camzyos 5268-A SGM P2023
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 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. Imaging reports, chart notes, or medical record
documentation supporting left ventricular wall thickness.
2. Laboratory results, chart notes, or medical record
documentation of familial hypertrophic cardiomyopathy or
a positive genetic test (e.g., MYH7, MYBPC3, TNNI3,
TNNT2, TPM1, MYL2, MYL3, ACTC1 gene variants) (if
applicable).
3. Chart notes or medical record documentation supporting
baseline left ventricular ejection fraction (LVEF) ≥ 55%
and baseline Valsalva left ventricular outflow tract (LVOT)
peak gradient ≥ 50 mmHg.
B. Continuation requests:
1. Chart notes or medical record documentation supporting
a positive clinical response to therapy (e.g., increase in
peak oxygen consumption [pVO2], NYHA class reduction).
2. Chart notes or medical record documentation supporting
left ventricular ejection fraction (LVEF) ≥ 50%.
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 anywhere in the left ventricle.
2. Left ventricular wall thickness of greater than or equal to
13 mm anywhere in the left ventricle in members with
familial hypertrophic cardiomyopathy or a positive genetic
test (e.g., MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2,
MYL3, ACTC1 gene variants).
B. Member has NYHA functional class II to class III symptoms
(see Appendix).
C. Member must have a baseline left ventricular ejection
fraction (LVEF) ≥ 55% and baseline Valsalva left ventricular
outflow tract (LVOT) peak gradient ≥ 50 mmHg.
D. Member has experienced an inadequate response to a beta-
adrenergic antagonist (e.g., atenolol, metoprolol) or non-
dihydropyridine calcium channel blocker (diltiazem,
verapamil) at maximally tolerated dose, or has an intolerance
or contraindication to both therapies.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for obstructive
hypertrophic cardiomyopathy when both of the following criteria
are met:
A. The member achieved or maintained a positive clinical
response to therapy (e.g., increase in pVO2, NYHA class
reduction).
B. Left ventricular ejection fraction (LVEF) ≥ 50%.
V. APPENDIX
New York Heart Association (NYHA) Functional Classification
|
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:
- Camzyos [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; June 2023.
- Ommen, SR, Mital S, Burke MA, 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. J Am Coll Cardiol. 2020;76(25):3022-3055.
- “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 April 3, 2023.
- Spertus JA, Fine JT, Elliott P, et al. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomized, double-blind placebo-controlled, phase 3 trial. 2021;397(10293):2467-2475.
- Maron B, Desai M, Nishimura R, et al. Management of Hypertrophic cardiomyopathy. J Am Coll Cardiol. 2022;79(4):390-414.
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.
November 28, 2023
