CurrentCentenePolicy CP PMN.70

Ivabradine (Corlanor) Clinical Policy — Coverage Criteria

This policy governs prior authorization, continuation, and coverage criteria for ivabradine (Corlanor) for treatment of symptomatic heart failure (adult and pediatric) under Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyIvabradine (Corlanor) Clinical Policy — Coverage Criteria

Policy CodePolicy CP PMN.70

Change TypeNo material changes

Effective DateNov 1, 2015

Next Review DateN/A

Key ActionSubmit documentation (office notes, lab results, or other clinical information) demonstrating the member meets initial or continued therapy criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

LVEF < 35%LVEF threshold

HR ≥ 70 bpmResting HR threshold

6 months+Pediatric lower age

12 moApproval duration

Weight-basedPediatric dosing updated

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Initial Therapy Criteria

Covered when ALL of the following are met for Initial Approval (Heart Failure):

Initial Approval - Heart Failure: 1) Diagnosis of chronic heart failure;

2) Prescribed by or in consultation with a cardiologist;

3) Age: pediatric specifics apply per policy (age-specific resting heart rate thresholds and pediatric LVEF criteria referenced in policy);

4) Left ventricular ejection fraction requirement for adults and pediatrics per policy (pediatric LVEF threshold noted in policy appendices);

5) Member is in sinus rhythm with a resting heart rate meeting the age-specific thresholds listed in the policy (adult threshold and clarified pediatric ranges per policy);

6) For branded Corlanor requests, member must use generic ivabradine unless (a) generic is contraindicated or results in clinically significant adverse effects, or (b) request is for Corlanor oral solution with documented inability to swallow tablets;

7) Failure of two of the following beta-blockers recommended for heart failure (bisoprolol; carvedilol immediate- or extended-release; metoprolol succinate extended-release) at up to maximally indicated doses, each used for ≥ 30 days, unless clinically significant adverse effects or contraindications prevent use;

8) Alternatively, member has used at least one of the aforementioned beta-blockers for ≥ 30 days when other agents are contraindicated or not tolerated;

9) Dose does not exceed both of the following: a) 15 mg per day; and b) policy maximum tablet or oral solution limits as specified (2 tablets or 15 mL per day equivalent);

Continuation Therapy Criteria

Covered when ALL of the following are met for Continued Therapy:

Continued Therapy - Heart Failure: 1) Member is currently receiving ivabradine/Corlanor via the Centene benefit or documentation supports member has received Corlanor for at least 30 days;

2) Member is responding positively to therapy (no clinically significant adverse effects or contraindications to continued treatment);

3) For branded Corlanor requests, member must use generic ivabradine unless generic is contraindicated or clinically significant adverse effects are documented, or the request is for the oral solution with documented inability to swallow tablets;

4) Dose limits for continued therapy: does not exceed 15 mg per day;

5) If the request is for a dose increase, the new dose must not exceed both policy limits (including tablet/solution maximums such as 2 tablets or 15 mL per day);

Coverage for non‑FDA approved indications that are not specifically addressed in this policy is not authorized unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid) or as allowed by the member’s evidence of coverage.

This clinical policy is a guide to medical necessity and does not supersede the terms, conditions, exclusions, or limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract). Coverage decisions remain subject to the member’s plan documents and applicable state and federal requirements; deviations from those documents may result in noncoverage or denial.

Use of ivabradine for non‑FDA approved indications without adequate documentation meeting the referenced off‑label use policies is considered not authorized and may be denied.

In this Part 2 excerpt there are no explicit entries listing conditions deemed 'not medically necessary.' The policy is presented as a clinical guidance document and coverage determinations remain subject to the member’s benefit terms and plan‑level administrative policies.

Affected Codes and Clinical Thresholds

Affected codesmixed

affected codes

Placeholder text in this Part 2 document indicating affected codes are referenced elsewhere in the policy

Resting heart rate thresholds — inv-09

Adult resting heart rate thresholdAdults: resting heart rate ≥ 70 beats per minute (FDA-approved indication for adults with LVEF < 35%).

Pediatric 6–<12 monthsAge 6 to <12 months: resting heart rate ≥ 105 beats per minute.

Pediatric >1–<3 yearsAge >1 to <3 years: resting heart rate ≥ 95 beats per minute.

Pediatric ≥3–<5 yearsAge ≥3 to <5 years: resting heart rate ≥ 75 beats per minute.

Pediatric ≥5 yearsAge ≥5 years: resting heart rate ≥ 70 beats per minute (aligns with adult threshold for older children).

Age-specific heart rate thresholds — inv-10

Clarified pediatric age rangesPolicy clarification updated 03.07.23 to specify pediatric age ranges and corresponding heart rate cutoffs used in initial criteria.

Age group 6 months to <12 monthsSpecified cutoff: ≥ 105 beats per minute (see initial criteria).

Age group >1 to <3 yearsSpecified cutoff: ≥ 95 beats per minute (see initial criteria).

Age group ≥3 to <5 yearsSpecified cutoff: ≥ 75 beats per minute (see initial criteria).

Age group ≥5 yearsSpecified cutoff: ≥ 70 beats per minute (see initial criteria and aligns with adult threshold).

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate the member meets the policy's initial or continued therapy criteria (diagnosis of chronic heart failure, specialist involvement, age and heart‑rate criteria, dosing limits, prior beta‑blocker therapy, and other clinical requirements).

Applies to brand Corlanor and generic ivabradine requests per plan formulary status.
Providers must follow Health Plan prior authorization processes and submit requests through the plan's established prior auth channels.

Documentation Required

Documentation Required to Support Requests

Providers must submit supporting clinical documentation to substantiate medical necessity. Acceptable documentation includes office chart notes, cardiology consultation notes, ECGs demonstrating sinus rhythm and resting heart rate, medication history, and relevant laboratory or imaging results.

Documentation should show member meets initial or continuation criteria (e.g., prior 30+ days of therapy when required).
For continuation: evidence the member has been receiving ivabradine/Corlanor through the Centene benefit or has documentation of at least 30 days of prior therapy.

Step Therapy

Beta‑Blocker Step Therapy

Step‑therapy requirement: prior trial of up to two guideline‑recommended beta‑blockers at maximally tolerated doses is required unless contraindicated or not tolerated. Each beta‑blocker trial should be for at least 30 days unless discontinued due to clinically significant adverse effects.

Recommended agents include bisoprolol, carvedilol (immediate- or extended‑release), and extended‑release metoprolol succinate.
If beta‑blockers are contraindicated or cause clinically significant adverse effects, document the reason for exemption.

Prior Authorization

Formulary Redirection to Generic

Formulary redirection may be applied for brand Corlanor requests. When generic ivabradine is the preferred formulary product, requests for brand Corlanor will be redirected to the generic unless there is documented medical necessity (e.g., contraindication, adverse effects, or inability to use generic formulation such as swallowing issues for tablets).

If requesting Corlanor oral solution due to inability to swallow tablets, include documentation.
Follow plan formulary and redirection policies when brand is non‑preferred.

Definitions and References

DCM — inv-21

TermDCM = dilated cardiomyopathy.

ContextDCM referenced in FDA pediatric indication for treatment of stable symptomatic heart failure due to dilated cardiomyopathy in patients 6 months and older.

Source locationDefined in Appendix A: Abbreviation/Acronym Key (Appendix A).

LVEF — inv-22

TermLVEF = left ventricular ejection fraction.

Adult threshold (FDA)FDA-approved adult indication specifies LVEF < 35% for reduced ejection fraction heart failure.

Appendix referenceLVEF abbreviation included in Appendix A: Abbreviation/Acronym Key.

Ivabradine/Corlanor prescribing information — inv-23

Manufacturer prescribing informationCorlanor Prescribing Information. Thousand Oaks, CA: Amgen Inc.; August 2021. Available at: https://www.corlanor.com. Accessed October 25, 2024.

FDA indications in PIPI documents adult indication to reduce risk of hospitalization in symptomatic chronic HF with LVEF < 35% and pediatric indication for DCM in patients 6 months and older who are in sinus rhythm with elevated heart rate.

Dosing/monitoring sourcePrescribing information cited as source for dosing, age limits, and monitoring recommendations referenced in the policy.

Guideline references — inv-24

Key guideline sources2013, 2016, 2017, 2022 ACC/AHA and HFSA guideline documents cited as evidence base for therapy recommendations.

Specific guideline examples2013 ACCF/AHA guideline for management of heart failure; 2016 and 2017 ACC/AHA/HFSA focused updates; 2022 AHA/ACC/HFSA guideline for management of heart failure.

Recent expert consensus2024 ACC Expert Consensus Decision Pathway for treatment of HF with reduced ejection fraction cited (JACC 2024).

Reference list locationReferences are listed in VI: References section of the policy document.

Policy Revision History

2024guideline_updateLatest

References updated to include the 2024 ACC Expert Consensus Decision Pathway for treatment of HFrEF (Maddox et al. 2024).

2022-11-22pandt_approval

Pharmacy & Therapeutics committee noted revised approval duration for Medicaid and Commercial lines of business (revision dated 06.23.22; P&T approval recorded 11.22).

2022-06-23policy_revision

Revised approval duration for Medicaid and Commercial lines of business.

2021-10-16annual_review

Annual review completed with references updated; no significant clinical policy statement changes noted.

2021-02-21pandt_approval

P&T committee recorded approval for the 1Q 2021 annual review (no significant changes).

OpenPayer

Ivabradine (Corlanor) Clinical Policy — Coverage Criteria

Coverage Criteria for Ivabradine (Corlanor)

Affected Codes and Clinical Thresholds

Prior Authorization, Documentation, and Step Therapy

Background on Ivabradine

Definitions and References

Policy Revision History