CurrentBlue Cross Blue Shield - IowaPolicy 05.04.38

Corlanor (ivabradine) drug coverage

Defines prior authorization requirements, dosing limits, and coverage criteria for Corlanor (ivabradine) for adult and pediatric patients for heart failure and selected compendial uses under Wellmark/Blue Cross Blue Shield.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyCorlanor (ivabradine) drug coverage

Policy CodePolicy 05.04.38

Change TypeNo material changes

Effective DateAugust 14, 2022

Next Review Date

Key ActionObtain prior authorization and submit documentation of LVEF ≤ 35%, evidence of guideline-directed medical therapy (including maximally tolerated beta-blocker or documented intolerance), sinus rhythm, and resting heart rate for initial approvals.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration

450 mL/30 daysoral solution limit

2/daytablet limit

≤35%LVEF requirement

≥70 bpmresting HR

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Coverage Criteria

Initial adult HFrEF therapy

Covered when ALL of the following are met for adult HFrEF

Adult HFrEF coverage: Patient is an adult; drug prescribed to reduce the risk of hospitalization for worsening heart failure in a patient with stable, symptomatic chronic heart failure; left ventricular ejection fraction (LVEF) <= 35% (documentation required); patient is currently receiving optimal therapy for heart failure management (e.g., ACEI/ARB/ARNI, beta-blocker, SGLT2i, MRA); patient is receiving treatment with a maximally tolerated dose of a beta-blocker OR has documented intolerance or contraindication to beta-blocker use; patient is in sinus rhythm; if the request is not for continuation of therapy, resting heart rate >= 70 beats per minute.

Approval duration 12 months

Pediatric DCM therapy

Covered when ALL of the following are met for pediatric DCM

Pediatric DCM coverage: Patient is pediatric age 6 months or older; drug prescribed for treatment of stable, symptomatic heart failure due to dilated cardiomyopathy (DCM); patient is in sinus rhythm; if the request is not for continuation of therapy, patient has an elevated heart rate.

Dose and monitoring per pediatric dosing guidance; approval duration 12 months

Compendial and IST use

Compendial use considered covered

Compendial use: Treatment of inappropriate sinus tachycardia (IST) in adults is a compendial use and may be covered when documentation supports medical necessity for symptom management (IST defined as sinus tachycardia unexplained by physiological demands with associated symptoms such as weakness, fatigue, lightheadedness, or palpitations).

IST therapy is symptom-driven; prognosis generally benign

This medical policy may not apply to FEP (Federal Employee Program). Benefit determinations for FEP members are made by the Federal Employee Program and may differ from the coverage described here; verify benefits under the applicable FEP contract.

Requests that do not meet the listed criteria will not satisfy medical necessity. Examples include absent documentation of LVEF ≤ 35% for adult HFrEF, lack of evidence of receipt of guideline-directed medical therapy (ACEI/ARB/ARNI, beta-blocker, SGLT2i, MRA), absence of documentation that the patient is receiving a maximally tolerated beta-blocker dose (or has a documented intolerance/contraindication), failure to document sinus rhythm, or missing resting heart rate documentation (for initial adult requests, resting HR ≥ 70 bpm). Such deficiencies may result in denial of the request.

Coding and Clinical Parameters

Procedures and billing codes referencedmixed

No codes listed

inv-07: Resting heart rate for adults — numeric threshold for initial approval

Numeric threshold for initial approval (adults)Resting heart rate greater than or equal to 70 beats per minute (≥ 70 BPM) for non‑continuation requests

Measurement requirementResting heart rate must be documented for initial approval; target resting HR during therapy is 50–60 BPM (dose adjustments recommended to achieve this range)

ApplicabilityApplies to adult patients being treated for stable, symptomatic chronic HFrEF when request is not for continuation of therapy

Approval durationStandard approval duration: 12 months

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for coverage. Approval is granted only when all listed criteria are met, including patient age and documented clinical parameters.

Prior authorization required
Approval when ALL listed criteria met

Denial Risk

Denial Triggers — Adults

Requests that do not meet the adult prior authorization criteria may be denied. Key denial triggers include absence of documentation or failure to meet clinical thresholds.

Patient is not an adult
No documentation of left ventricular ejection fraction (LVEF) ≤ 35%
Lack of documentation that patient is on optimal guideline-directed medical therapy (GDMT) for heart failure (ACEI/ARB/ARNI, beta-blocker, SGLT2 inhibitor, MRA as appropriate)

Background

Ivabradine (Corlanor) is indicated to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure and reduced left ventricular ejection fraction. Coverage considerations require documentation of heart failure status, LVEF ≤ 35%, and that the patient is receiving optimal guideline-directed medical therapy including a beta-blocker at a maximally tolerated dose or a documented contraindication/intolerance. The mechanism of action lowers heart rate by selective inhibition of the If current in the sinoatrial node, thereby reducing cardiac workload and improving symptoms in appropriate patients. In pediatric patients aged 6 months and older, ivabradine is used for symptomatic heart failure due to dilated cardiomyopathy when the patient is in sinus rhythm and has an elevated heart rate; dosing and monitoring follow pediatric guidance. Compendial use for symptomatic inappropriate sinus tachycardia in adults is also recognized when documentation supports medical necessity.

Definitions

inv-14: Inappropriate sinus tachycardia (IST) — definition and features

DefinitionInappropriate sinus tachycardia (IST) is sinus tachycardia unexplained by physiological demands at rest, with minimal exertion, or during recovery from exercise

Associated symptomsMay include weakness, fatigue, lightheadedness, palpitations or sensations of heart racing; symptoms can be debilitating

Prognosis and treatment intentPrognosis is generally benign; treatment is symptom‑directed rather than required for prognosis

Role of ivabradineIvabradine use is reasonable for ongoing management in patients with symptomatic IST when symptom reduction is the goal