POLICY NUMBER

L.5.01.637

Camzyos (mavacamten)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Hypertrophic cardiomyopathy (HCM) is a common genetic heart disease and is often inherited in an autosomal dominant pattern caused by mutation in one of several sarcomere genes. HCM is characterized by left ventricular hypertrophy in the absence of another cardiac, systemic, or metabolic disease capable of producing the magnitude of hypertrophy. Signs and symptoms of HCM are variable and may include dyspnea on exertion, fatigue, chest pain, syncope, and palpitation. Heart failure is the most common presentation and occurs in over 90% of symptomatic patients. Depending on the site and extent of hypertrophy, LV outflow obstruction, diastolic dysfunction, myocardial ischemia, and/or mitral regurgitation may develop.

Camzyos (mavacamten) is a cardiac myosin inhibitor indicated for the treatment of adults and pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Camzyos (mavacamten) may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual is at least 18 years of age; OR

   2. The individual is at least 12 years of age and weighs at least 30kg;

2. The individual has BOTH of the following:

   1. Diagnosis of obstructive hypertrophic cardiomyopathy (HCM); AND

   2. New York Heart Association (NYHA) Class II or Class III heart failure;

3. ALL of the following:

   1. The individual’s baseline (prior to therapy with the requested agent) left ventricular ejection fraction (LVEF) is at least 55%;

   2. There is no known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive HCM (e.g., Fabry disease, amyloidosis, Noonan syndrome with left ventricular hypertrophy); AND

   3. ONE of the following:

      1. The individual tried and had an inadequate response to at least one beta blocker (e.g., atenolol, metoprolol, bisoprolol) OR non-dihydropyridine calcium channel blocker (e.g., diltiazem, verapamil) [see definition of Medication Failure in the Policy Guidelines section]; OR

      2. The individual has an intolerance, hypersensitivity, or contraindication to beta blockers and calcium channel blockers;

4. If female of reproductive potential, the individual is not pregnant and will be advised to use effective contraception during treatment with the requested agent and for 4 months after the last dose;

5. The prescriber is a specialist or has consulted with a specialist in the area of the individual’s diagnosis (e.g., cardiologist);

6. The individual does NOT have any FDA labeled contraindications to the requested agent; AND

7. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Camzyos (mavacamten) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for the requested agent through BCBSMS PA process;

2. The individual has had clinical benefit with the requested agent (i.e. slowing of disease progression or decrease in symptom severity and/or frequency);

3. The individual has a left ventricular ejection fraction (LVEF) of at least 50%;

4. The prescriber is a specialist or has consulted with a specialist in the area of the individual’s diagnosis (e.g., cardiologist);

5. The individual does NOT have any FDA labeled contraindications to the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication failure is defined as disease progression despite maximally tolerated dose as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

POLICY HISTORY

10/09/2026: New policy added.

SOURCE(S)

1. Camzyos prescribing information. Myokardia Inc. April 2025. Last accessed July 2026.

2. Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation 2024; 149:e1239.

3. Maron, MS. Hypertrophic cardiomyopathy: Clinical Manifestations, diagnosis, and evaluation. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Accessed on July 14, 2026)

CODE REFERENCE

None