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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 |
10/1/2023 |
|
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. |
|
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/Heart Failure Society of America) 2022 Guideline for the Management of Heart Failure states that ivabradine can be beneficial to reduce HF hospitalizations and cardiovascular death 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 medical therapy (GDMT), 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)
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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) |
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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) |
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Safety |
Ivabradine is contraindicated in patients with:
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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/. |
3 |
2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure. A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Available at: https://www.acc.org/guidelines/hubs/heart-failure |
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
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
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 Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Corlanor |
ivabradine hcl oral soln |
5 MG/5ML |
600 |
mLs |
30 |
DAYS |
|
|
|
Corlanor |
ivabradine hcl tab |
5 MG ; 7.5 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
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
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
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 |
||
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
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:
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 |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
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 _ Hyperpolarization-Activated Cyclic Nucleotide-Gated (HCN) Channel Blocker (Corlanor) Prior Authorization with Quantity Limit _ProgSum_ 10/1/2023