CurrentUnitedHealthcarePolicy N/A

Corlanor (ivabradine) prior authorization

Defines UnitedHealthcare's prior authorization and medical necessity criteria for Corlanor (ivabradine) for members, including initial and reauthorization requirements and authorized prescriber expectations.

Policy Summary

PayerUnitedHealthcare

PolicyCorlanor (ivabradine) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, LVEF, heart rhythm and resting HR, prior/concurrent therapies or contraindications, and cardiology involvement when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

<35%LVEF threshold

≥70 bpmresting HR requirement

Cardiologistprescriber

Coverage and Authorization Criteria

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Initial Authorization - dilated cardiomyopathy (DCM): Diagnosis of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) AND patient is in sinus rhythm AND patient has an elevated heart rate AND therapy is prescribed by or in consultation with a cardiologist

Authorization issued for 12 months

Initial Authorization - inappropriate sinus tachycardia (IST): Diagnosis of inappropriate sinus tachycardia (IST) AND patient is in sinus rhythm AND (ONE of: patient has tried and failed or had an inadequate response to a beta-blocker; or patient has a contraindication or intolerance to beta-blocker therapy) AND therapy is prescribed by or in consultation with a cardiologist

Authorization issued for 12 months

Established on therapy: Patient is currently established on Corlanor (ivabradine) therapy

Authorization issued for 12 months

Coverage for Corlanor (ivabradine) is subject to plan, program, state and federal rules. Typically excluded from coverage may apply under certain benefit designs or programs, and supply limits may be imposed. UnitedHealthcare may also use prior claim or medication history, diagnosis coding, and automated claim logic to approve initial or reauthorizations in some programs, which can affect authorization decisions.

When applying medical necessity criteria, plan-specific or regulatory requirements (state/federal) and benefit plan limitations take precedence and can restrict coverage even when clinical criteria are met. Providers should confirm member benefit details and any applicable supply limits before prescribing.

Key Clinical Thresholds

inv-04: Resting heart rate — numeric threshold for eligibility

Resting heart rate requirementResting heart rate ≥ 70 beats per minute

Context within HF criteriaRequired for initial authorization in chronic systolic heart failure (must be in sinus rhythm with resting HR ≥ 70)

Pediatric DCM noteElevated resting heart rate required for pediatric DCM indication (per background guidance)

inv-05: Left ventricular ejection fraction — numeric threshold for eligibility

Left ventricular ejection fraction thresholdLVEF < 35%

Role in authorizationRequired for initial authorization for chronic symptomatic heart failure (with sinus rhythm and HR ≥ 70)

Source statementLVEF < 35% is the EF threshold specified in the policy and product background

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Corlanor (ivabradine). Requests meeting the initial authorization criteria will be approved. Authorization length: 12 months for approved cases.

Effective Date: 2024-12-01
Authorization duration: 12 months

Step Therapy

Concomitant Therapy / Step Requirements

Prior to approval, patients must be on or have documented intolerance/contraindication to specified concomitant therapies. If applicable, documentation of stabilization on therapy is required.

Beta-blocker requirement: Patient must be on a stabilized, maximally tolerated dose of a beta-blocker (e.g., carvedilol, metoprolol succinate, bisoprolol), OR have a documented contraindication or intolerance to beta-blocker therapy.
SGLT2 inhibitor requirement: Patient must be on a stabilized dose of an SGLT2 inhibitor (empagliflozin [Jardiance], dapagliflozin [Farxiga], or combination products) OR have a documented contraindication or intolerance to SGLT2 inhibitor therapy.
RAAS/ARNI requirement: Patient must be on a stabilized dose of one of the following where appropriate: ACE inhibitor (e.g., captopril, enalapril), ARNI (sacubitril/valsartan [Entresto]), or an angiotensin II receptor blocker (e.g., candesartan, valsartan).
Aldosterone antagonist requirement: Patient must be on a stabilized, maximally tolerated dose of an aldosterone antagonist (e.g., spironolactone, eplerenone) OR have a documented contraindication or intolerance to aldosterone antagonist therapy.

Documentation Required

Required Documentation

Provide complete clinical documentation to support medical necessity and expedite review. Missing or insufficient documentation is a common cause for denial.

Diagnosis and clinical indication (e.g., worsening stable, symptomatic chronic heart failure; NYHA class II–IV where applicable).
Left ventricular ejection fraction (LVEF) value showing < 35%.
Cardiac rhythm documentation confirming patient is in sinus rhythm.
Resting heart rate documented and ≥ 70 beats per minute.
Evidence of concomitant therapies and stabilization (medication names, doses, dates of stabilization) or documented contraindications/intolerances for required drug classes (beta-blocker, SGLT2 inhibitor, ACE/ARB/ARNI, aldosterone antagonist).
Prior trials and responses (e.g., trial and failure or inadequate response to beta-blocker when applicable), including dates and reasons for discontinuation if intolerance/contraindication claimed.
Prescriber specialty or documentation of cardiology consultation (prescribed by or in consultation with a cardiologist) when required by criteria.
For continuation requests, documentation of current Corlanor therapy and clinical response.

Denial Risk

Triggers for Denial

Denials commonly occur when required criteria or supporting documentation are missing, conflicting, or insufficient.

No documentation of LVEF < 35%.
No documentation that patient is in sinus rhythm.
No resting heart rate documented as ≥ 70 bpm.
Lack of evidence of stabilization on required concomitant therapies or absence of documented contraindication/intolerance when step requirements are not met.
Missing prescriber specialty or absence of documented cardiology consultation when required.
Incomplete medication history or missing dates/doses to show prior trials, stabilization, or intolerance.
Requests that do not demonstrate the specific covered diagnoses (e.g., inappropriate indication such as non-dilated cardiomyopathy without meeting other criteria).

Background

Ivabradine (Corlanor) is used to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic systolic heart failure. Appropriate candidates are those with left ventricular ejection fraction (LVEF) < 35%, who are in sinus rhythm with a resting heart rate ≥ 70 beats per minute, and who are on a stabilized, maximally tolerated beta‑blocker or have a documented contraindication/intolerance to beta‑blocker therapy.

Corlanor is also considered for other clinical contexts described in the policy: stable symptomatic dilated cardiomyopathy (DCM) with elevated heart rate and for patients with inappropriate sinus tachycardia (IST) who have failed or cannot tolerate beta‑blockers. For the heart failure indications, authorization is expected to be prescribed by or in consultation with a cardiologist and initial approvals are issued for 12 months.

Definitions

inv-11: Inappropriate sinus tachycardia (IST) — definition and relevance to policy

DefinitionInappropriate sinus tachycardia (IST) is a condition characterized by an abnormally elevated sinus heart rate that is inappropriate for physiologic demands.

Policy relevanceIvabradine has demonstrated efficacy for IST; the policy includes IST as an indication-specific group for initial authorization when criteria are met.

Authorization requirementsFor IST, patient must have diagnosis of IST, be in sinus rhythm, have tried and failed or be intolerant to a beta‑blocker (or have a contraindication), and therapy must be prescribed by or in consultation with a cardiologist.

Policy Summary

PayerUnitedHealthcare

PolicyCorlanor (ivabradine) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, LVEF, heart rhythm and resting HR, prior/concurrent therapies or contraindications, and cardiology involvement when required.

SourceLink

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