CurrentmhnPolicy CP.PMN.70

Clinical Policy: Ivabradine (Corlanor)

Defines medical necessity criteria, dosing limits, prior authorization requirements, and coverage duration for ivabradine (Corlanor) for heart failure in adults and pediatric patients across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Ivabradine (Corlanor)

Policy CodePolicy CP.PMN.70

Change TypeRevised; Clarified; Administrative

Effective Date11.01.15

Next Review Date

Key ActionProvider must submit documentation demonstrating member meets all approval criteria, including LVEF, heart rate, prior beta-blocker use, age and cardiology involvement.

POLICY UPDATE CHANGES

Clarified age ranges and corresponding beats per minute in initial criteria.

Updated Section V to include specific weight-based maximum doses for pediatric patients per prescribing information and revised policy/criteria to include generic ivabradine and redirection to generic for brand requests.

Revised approval duration for Medicaid and Commercial line of business from length of benefit to 12 months or duration of request.

Multiple annual reviews noted as 'no significant changes'; references reviewed and updated on multiple dates.

1FDA-approved adult HF indication (reduced EF)

1FDA-approved pediatric DCM indication (≥6 months)

15 mg/dayMaximum daily dose

12 months

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines medical necessity criteria, dosing limits, prior authorization requirements, and coverage duration for ivabradine (Corlanor) for heart failure in adults and pediatric patients across Commercial, HIM, and Medicaid lines of business.

FDA‑approved indications: Corlanor is indicated in adults to reduce risk of hospitalization for worsening heart failure in stable, symptomatic chronic heart failure with LVEF ≤ 35% in sinus rhythm with resting HR ≥ 70 bpm (and on maximally tolerated beta‑blocker therapy or with contraindication), and in pediatric patients aged ≥ 6 months for treatment of symptomatic heart failure due to dilated cardiomyopathy in sinus rhythm with elevated heart rate. Approval duration: 12 months (HIM, Medicaid, Commercial per policy). Dosing overview: adult/pediatric ≥ 40 kg dosing starts at 2.5 mg or 5 mg PO BID with a maximum of 15 mg/day (≤ 7.5 mg BID); pediatric patients < 40 kg use weight‑based dosing with a maximum of 0.2 mg/kg/day per prescribing information (policy dose limits also state ≤ 15 mg/day and ≤ 2 tablets/day or ≤ 15 mL/day).

Key thresholds

Adult maximum daily dose≤ 15 mg/day

Tablet/oral solution max per day≤ 2 tablets/day or ≤ 15 mL/day

Pediatric max dose (<40 kg)≤ 0.2 mg/kg/day (per prescribing information)

Heart rate threshold — age 6–12 months≥ 105 beats per minute

Heart rate threshold — age >1 to <3 years≥ 95 beats per minute

Heart rate threshold — age ≥3 to <5 years≥ 75 beats per minute

Heart rate threshold — age ≥5 years≥ 70 beats per minute

Approval duration12 months

Initial Therapy Criteria — Heart Failure

Initial Therapy Criteria — Other Indications / Off‑Label

I. Initial Approval Criteria - Other diagnoses/indications

Must meet ONE of the following (1 or 2):

ANY of the following

If drug has recently (within last 6 months) undergone a label change not yet reflected in this policy, follow formulary/non-formulary policies referenced (see policy for CP numbers) for coverage determination
If requested use is NOT specifically listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial; HIM.PA.154 for HIM; CP.PMN.53 for Medicaid)

Continuation (Renewal) Criteria

Unapproved / Not Authorized Indications

III. Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

Applicable Codes

Product availability (drug strengths/forms)NDC

Tablets 5 mg	Product available as 5 mg tablets
Tablets 7.5 mg	Product available as 7.5 mg tablets
Oral solution 5 mg/5 mL	Product available as oral solution

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior authorization required

Requests require prior authorization and will be reviewed against the policy criteria. For initial approval, the prescriber must be a cardiologist or the request must be made in consultation with a cardiologist.

Applies to Commercial, HIM, Medicaid

Documentation Required

Support approval criteria

Provider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including left ventricular ejection fraction (LVEF), resting heart rate, prior beta-blocker use, age, and that the drug was prescribed by or in consultation with a cardiologist.

Clinical Evidence & References

Primary evidence source: Corlanor Prescribing Information, Amgen; August 2021 (accessed Oct 25, 2024) is cited as the primary PI reference informing indications and dosing.

Guideline and consensus sources referenced in the policy include ACCF/AHA guideline (2013) and subsequent focused updates (2016, 2017), the 2022 AHA/ACC/HFSA Guideline for management of heart failure, and the 2024 ACC Expert Consensus Decision Pathway for treatment of HFrEF; these guideline documents are listed in the policy references.

Background

Ivabradine is an HCN (hyperpolarization‑activated cyclic nucleotide‑gated) channel blocker. It is indicated to reduce hospitalization risk in adults with symptomatic chronic heart failure with reduced ejection fraction and sinus rhythm, and to treat symptomatic heart failure due to dilated cardiomyopathy in pediatric patients aged ≥ 6 months with elevated heart rate; the policy requires LVEF thresholds and sinus rhythm with age‑specific resting heart rate criteria to define the indicated patient population.

Definitions

DCMdilated cardiomyopathy

LVEFleft ventricular ejection fraction

FDAFood and Drug Administration

Revision History

03.07.23clarified

Clarified age ranges and corresponding beats per minute in initial criteria; administrative/clarifying change (not material).

06.23.22revised

Revised approval duration for Medicaid and Commercial line of business from length of benefit to 12 months or duration of request; marked as material (P&T Approval Date 11.22).

01.07.25revisedLatest