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Camzyos (mavacamten) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1180

 

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

1/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Camzyos™

(mavacamten) 

Capsule

 

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

1

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Hypertrophic cardiomyopathy (HCM)

Hypertrophic cardiomyopathy (HCM) is a common genetic heart disease reported in populations globally.  Inherited in an autosomal dominant pattern, the distribution is equal by sex, although women are diagnosed less commonly than men.  The prevalence of unexplained asymptomatic hypertrophy in young adults in the United States has been reported to range from 1:200 to 1:500.  Symptomatic hypertrophy based on medical claims data has been estimated at less than 1:3000 adults in the United States; however, the true burden is much higher when unrecognized disease in the general population is considered.  Clinical evaluation for HCM may be triggered by occurrence of symptoms, a cardiac event, detection of a heart murmur, an abnormal 12-lead EKG identified on routine examinations, or through cardiac imaging during family screening studies.(2)  

Efficacy

Mavacamten is a reversible inhibitor selective for cardiac myosin.  Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation.  Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM.  In HCM patients, myosin inhibition with mavacamten reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.

The efficacy of Camzyos was evaluated in EXPLORER-HCM, a phase 3, double-blind, randomized, placebo-controlled, multicenter, international, parallel group trial in 251 adults with symptomatic NYHA class II and III obstructive HCM, LVEF greater than or equal to 55%, and Valsalva LVOT peak gradient greater than or equal to 50 mmHg at rest or with provocation.  Patients on dual therapy with beta blocker and calcium channel blocker treatment or monotherapy with disopyramide or ranolazine were excluded. Patients with a known infiltrative or storage disorder causing cardiac hypertrophy that mimicked obstructive HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy, were also excluded. Patients were randomized in a 1:1 ratio to receive either a starting dose of 5 mg of Camzyos or placebo once daily for 30 weeks. Treatment assignment was stratified by baseline disease severity NYHA functional class, baseline use of beta blockers, and type of ergometer (treadmill or exercise bicycle). Groups were well matched with respect to age (mean 59 years), BMI (mean 30 kg/m), heart rate (mean 62 bpm), blood pressure (mean 128/76 mmHg), and race (90% Caucasian). Males comprised 54% of the Camzyos group and 65% of the placebo group. At baseline, approximately 73% of the randomized patients were NYHA class II and 27% were NYHA class III. The mean LVEF was 74%, and the mean Valsalva LVOT gradient was 73 mmHg. About 10% had prior septal reduction therapy, 75% were on beta 2 blockers, 17% were on calcium channel blockers, and 14% had a history of atrial fibrillation.  All patients were initiated on Camzyos 5 mg (or matching placebo) once daily, and the dose was periodically adjusted to optimize patient response (decrease in LVOT gradient with Valsalva maneuver) and maintain LVEF greater to or equal to 50%.

The primary composite functional endpoint, assessed at 30 weeks, was defined as the proportion of patients who achieved either improvement of mixed peak oxygen consumption (pVO) by greater than or equal to 1.5 mL/kg/min plus improvement in NYHA class by at least 1 or improvement of pVO by greater than or equal to 3.0 mL/kg/min plus no worsening in NYHA class. A greater proportion of patients met the primary endpoint at Week 30 in the Camzyos group compared to the placebo group (37% vs. 17%, respectively, p=0.0005).(1)

Safety

Camzyos carries a black box warning for the risk of heart failure.  Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments of LVEF are required prior to and during treatment with Camzyos. Initiation of Camzyos in patients with LVEF is not recommended. Interrupt Camzyos if LVEF is less than 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Camzyos also carries a black box warning for use with other cytochrome P450 affected medications.  Concomitant use of Camzyos with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of Camzyos is contraindicated with the following:

  • Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, Camzyos is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Camzyos REMS Program.(1)

REFERENCES                                                                                                                                                                            

Number

Reference

1

Camzyos Prescribing Information. MyoKardia (a wholly-owned subsidiary of Bristol Meyers Squibb).  May 2022.

2

Ommen SR. Mital, S, Burke MA, et. al. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy.  Circulation 142.  (25), e558-e361.  December 22, 2020.  Available at: https://www.ahajournals.org/doi/epub/10.1161/CIR.0000000000000937

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Agent Names

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

CAMZYOS*mavacamten cap

10 MG ; 15 MG ; 2.5 MG ; 5 MG

M ; N ; O ; Y

N

01-01-2023

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Agent GPI

Agent Names

Strength

QL Amount

Dose Form

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

40190050000130

CAMZYOS*Mavacamten Cap 10 MG

10 MG

30.0

CAPS

30

Days

01-01-2023

40190050000140

CAMZYOS*Mavacamten Cap 15 MG

15 MG

30.0

CAPS

30

Days

01-01-2023

40190050000110

CAMZYOS*Mavacamten Cap 2.5 MG

2.5 MG

30.0

CAPS

30

Days

01-01-2023

40190050000120

CAMZYOS*Mavacamten Cap 5 MG

5 MG

30.0

CAPS

30

Days

01-01-2023

CLIENT SUMMARY – PRIOR AUTHORIZATION

Agent Names

Strength

Client Formulary

CAMZYOS*mavacamten cap

10 MG ; 15 MG ; 2.5 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names

Strength

Client Formulary

CAMZYOS*Mavacamten Cap 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CAMZYOS*Mavacamten Cap 15 MG

15 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CAMZYOS*Mavacamten Cap 2.5 MG

2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CAMZYOS*Mavacamten Cap 5 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
    3. ALL of the following:
      1. The patient has a diagnosis of symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) AND
      2. The requested agent will be used to improve functional capacity and symptoms AND
      3. The patient does not have a known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy AND
      4. ONE of the following:
        1. The patient has tried and had an inadequate response to a beta blocker OR
        2. The patient has an intolerance or hypersensitivity to therapy with beta blockers OR
        3. The patient has an FDA labeled contraindication to ALL beta blockers AND
      5. ONE of the following
        1. The patient has tried and had an inadequate response to a calcium channel blocker OR
        2. The patient has an intolerance or hypersensitivity to therapy with calcium channel blockers OR
        3. The patient has an FDA labeled contraindication to ALL calcium channel blockers OR
    4. The patient has another FDA approved indication for the requested agent and route of administration AND
  2. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  4. The prescriber is enrolled in the Camzyos Risk Evaluation and Mitigation Strategy (REMS) program AND
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

 

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  2. The patient has had clinical benefit with the requested agent AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
  4. The prescriber is enrolled in the Camzyos Risk Evaluation and Mitigation Strategy (REMS) program AND
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

 

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
  3. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
    3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

 

Length of Approval: 12 months

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

Commercial _ PS _ Camzyos (mavacamten) Prior Authorization with Quantity Limit _ProgSum_ 1/1/2023