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Hyperpolarization-Activated Cyclic Nucleotide-Gated (HCN) Channel Blocker (Corlanor) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1044

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

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

10/1/2022              

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Corlanor®

Tablet, Solution

To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction less than or equal to 35%, who are in sinus rhythm with resting heart rate greater than or equal to 70 beats per minute and either are on maximally tolerated doses of beta blockers or have a contraindication to beta-blocker use.

 

Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

1

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

CLINICAL RATIONALE

Heart Failure

The ACCF/AHA/HFSA (American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines/Heart Failure Society of America) focused update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure states that ivabradine can be beneficial to reduce HF hospitalization for patients with symptomatic (NYHA class II-III) stable chronic heart failure with reduced ejection fraction (HFrEF) (LVEF less than or equal to 35%) who are receiving guideline directed evaluation and management (GDEM), including a beta blocker at maximum tolerated dose, and who are in sinus rhythm with a heart rate of 70 bpm or greater at rest.(3)

 

The ACCF/AHA guideline classifies heart failure by the following in relation to New York Heart Association (NYHA) Functional Classification:(2)

ACCF/AHA Stages of HF

ACCF/AHA Stage Description

NYHA Functional Classification

NYHA Functional Classification Description

A

At high risk for HF but without structural heart disease or symptoms of HF

None

None

B

Structural heart disease but without signs or symptoms of HF

I

No limitation of physical activity.  Ordinary physical activity does not cause symptoms of HF

C

Structural heart disease with prior or current symptoms of HF

I

No limitation of physical activity.  Ordinary physical activity does not cause symptoms of HF

II

Slight limitation of physical activity.  Comfortable at rest, but ordinary physical activity results in symptoms of HF

III

Marked limitation of physical activity.  Comfortable at rest, but less than ordinary activity causes symptoms of HF

IV

Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest

D

Refractory HF requiring specialized interventions

IV

Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest 

 

The ACCF/AHA guideline recommends the following algorithm for the treatment of HFrEF (less than or equal to 40%) ACCF/AHA Class C and NYHA Class I-IV:(2)

  • All patients should receive an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), or angiotensin receptor/neprilysin inhibitor (ARNI) in addition to a beta blocker(3)
  • For volume overloaded NYHA Class II-IV patients, a loop diuretic should be added
  • For persistently symptomatic African American NYHA class III-IV patients, hydralazine and isosorbide dinitrate should be added
  • For NYHA Class II-IV patients with estimated creatinine greater than 30 mL/min and potassium less than 5.0 mEq/dL, an aldosterone antagonist should be added

Dilated Cardiomyopathy (DCM)

Dilated cardiomyopathy (DCM) is a clinical diagnosis characterized by left ventricular or biventricular dilation and impaired contraction that is not explained by abnormal loading conditions (for example, hypertension and valvular heart disease) or coronary artery disease. Mutations in several genes can cause DCM, including genes encoding structural components of the sarcomere and desmosome. Nongenetic forms of DCM can result from different etiologies, including inflammation of the myocardium due to an infection (mostly viral); exposure to drugs, toxins or allergens; and systemic endocrine or autoimmune diseases.  The heterogeneous etiology and clinical presentation of DCM make a correct and timely diagnosis challenging. Echocardiography and other imaging techniques are required to assess ventricular dysfunction and adverse myocardial remodeling. Immunological and histological analyses of an endomyocardial biopsy sample are indicated when inflammation or infection is suspected. As DCM eventually leads to impaired contractility, standard approaches to prevent or treat heart failure are the first-line treatment for patients with DCM. Cardiac resynchronization therapy and implantable cardioverter–defibrillators may be required to prevent life-threatening arrhythmias.(4)

Efficacy

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility.  It gained its indication for heart failure in adult patients via the systolic heart failure treatment with the If inhibitor ivabradine trial (SHIFT). This was a randomized, double-blind trial comparing Corlanor and placebo in 6558 patients with stable NYHA class II to IV heart failure, left ventricular ejection fraction less than or equal to 35%, and resting heart rate greater than or equal to 70 bpm. Patients had to have been clinically stable for at least 4 weeks on an optimized and stable clinical regimen, which included maximally tolerated doses of beta blockers and, in most cases, ACE inhibitors or ARBs, spironolactone, and diuretics, with fluid retention and symptoms of congestion minimized.  SHIFT demonstrated that Corlanor reduced the risk of the combined endpoint of hospitalization for worsening heart failure or cardiovascular death based on a time-to-event analysis.  Because Corlanor was effective in improving outcomes in patients with dilated cardiomyopathy (DCM) in SHIFT, the effect on heart rate was considered a reasonable basis to infer clinical benefits in pediatric patients with DCM. Thus, Corlanor was evaluated for its effect on heart rate in a multi-center, randomized, double-blind, placebo-controlled trial in children with symptomatic DCM. The study collected data from 116 patients 6 months to less than 18 years old with DCM in sinus rhythm, NYHA/Ross class II to IV heart failure, and left ventricular ejection fraction less than or equal to 45%. A statistically significant reduction in heart rate was observed with Corlanor compared to placebo at the end of the titration period (-23 plus or minus 11 bpm vs. -2 plus or minus 12 bpm respectively).(1)

Safety

Ivabradine is contraindicated in patients with:

  • Acute decompensated heart failure
  • Clinically significant hypotension
  • Sick sinus syndrome, sinoatrial block, or 3rd degree AV block, unless a functioning demand pacemaker is present
  • Clinically significant bradycardia
  • Severe hepatic impairment
  • Pacemaker dependence (heart rate maintained exclusively by the pacemaker)
  • Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors(1)

REFERENCES                                                                                                                                                                            

Number

Reference

1

Corlanor prescribing information. Amgen Inc. August 2021.

2

2013 ACCF/AHA Guideline for the Management of Heart Failure. Accessed at http://circ.ahajournals.org/. Accessed March 23, 2020.

3

2017 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Accessed on March 23, 2020.  https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000509

4

Heinz-Peter S, Fairweather D, Calforio AL, et. al.  Dilated cardiomyopathy. Nat Rev Dis Primers.  2018; 5(1): 32.  Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574280/

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Agent Names

Strength

Targeted MSC

Available MSC

Effective Date

CORLANOR*ivabradine hcl oral soln

5 MG/5ML

M ; N ; O ; Y

N

CORLANOR*ivabradine hcl tab

5 MG ; 7.5 MG

M ; N ; O ; Y

N

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

407000351020

CORLANOR*ivabradine hcl oral soln

5 MG/5ML

600.0

MLS

30

Days

407000351003

CORLANOR*ivabradine hcl tab

5 MG ; 7.5 MG

60.0

TABS

30

Days

CLIENT SUMMARY – PRIOR AUTHORIZATION

Agent Names

Strength

Client Formulary

CORLANOR*ivabradine hcl oral soln

5 MG/5ML

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

CORLANOR*ivabradine hcl tab

5 MG ; 7.5 MG

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

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names

Strength

Client Formulary

CORLANOR*ivabradine hcl oral soln

5 MG/5ML

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

CORLANOR*ivabradine hcl tab

5 MG ; 7.5 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 within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
    3. BOTH of the following:
      1. The patient has stable, symptomatic heart failure (e.g., NYHA Class II, III, IV; ACCF/AHA Class C, D) AND
      2. ONE of the following:
        1. ALL of the following:
          1. The patient has heart failure due to dilated cardiomyopathy (DCM) AND
          2. The patient is in sinus rhythm with an elevated heart rate OR
        2. ALL of the following:
          1. The patient has a baseline OR current left ventricular ejection fraction of less than or equal to 35% AND
          2. Prior to initiating therapy with the requested agent, the patient is in sinus rhythm with a resting heart rate of greater than or equal to 70 beats per minute AND
          3. ONE of the following:
            1. The patient will be using standard CHF therapy (e.g., beta blockers, ACE inhibitors) in combination with the requested agent OR
            2. The patient has an intolerance, hypersensitivity or FDA labeled contraindication to ALL standard CHF therapy (e.g., beta blockers, ACE inhibitors) that is no expected to occur with the requested agent 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 AND
  3. The patient does NOT have any FDA labeled contraindications to the requested agent

 

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria

 

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. If the requested agent is being used for heart failure (not due to DCM), ONE of the following:
    1. The patient will be using standard CHF therapy (e.g., beta blockers, ACE inhibitors) in combination with the requested agent OR
    2. The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL standard CHF therapy (e.g., beta blockers, ACE inhibitors) that is not expected to occur with the requested agent AND
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

 

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria

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

 

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.

 

 

BCBSAL _  PS _ Hyperpolarization-Activated Cyclic Nucleotide-Gated (HCN)  Channel Blocker (Corlanor) Prior Authorization with Quantity Limit _ProgSum_ 10/1/2022  _