CurrentMass General Brigham Health PlanPolicy N/A

Corlanor (ivabradine) coverage and prior authorization

Policy governing prior authorization, quantity limits, and clinical criteria for Corlanor (ivabradine) under Mass General Brigham Health Plan applicable to Commercial/Exchange and MassHealth UPPL members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCorlanor (ivabradine) coverage and prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation including cardiologist prescriber or cardiology consult, resting heart rate evidence, and beta-blocker treatment status or rationale.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 moapproval duration

<35%LVEF threshold

≥70 bpmresting HR threshold

Cardiologistprescriber

Coverage Criteria for Corlanor (ivabradine)

Initial approval criteria

Policy Summary

PayerMass General Brigham Health Plan

PolicyCorlanor (ivabradine) coverage and prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation including cardiologist prescriber or cardiology consult, resting heart rate evidence, and beta-blocker treatment status or rationale.

SourceLink

On This Page

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Prescriber requirement: Prescriber is a cardiologist or a cardiology consult is provided

Resting heart rate (age-dependent): For members ≥18 years: resting heart rate ≥ 70 beats per minute; For members 6 months to 17 years: resting heart rate within age-normal range per appendixAdults >=70 bpm; pediatric per appendix

See policy appendix for pediatric normal ranges

Beta-blocker therapy: Member is currently receiving a beta-blocker (carvedilol, metoprolol succinate, or bisoprolol) at maximally tolerated age-appropriate doses OR a clinical rationale why a beta-blocker cannot be used has been submitted

Specific agents named in policy

ACEi/ARB/ARNI combination therapy: Either: (1) Member has received standard-of-care therapy with an ACE inhibitor, ARB, or ARNI in combination with a beta-blocker; OR (2) a clinical rationale why the member cannot receive ACEi/ARB/ARNI plus a beta-blocker has been submitted

Policy requires either prior combination therapy or documented contraindication

Clinical Thresholds and Coding

inv-03: Resting heart rate

Adult resting heart rate≥ 70 beats per minute (bpm)

Pediatric resting heart rateAge-based normal ranges (see appendix) — e.g., 6–12 months normal, 2–105 bpm; 2–3 years normal ~95 bpm; 3–5 years normal ~75 bpm; 5–25 years normal ~70 bpm

Pediatric bradycardia examplesExamples in appendix: 6–12 months bradycardia = 80 bpm; 2–3 years bradycardia = 70 bpm; 3–5 years bradycardia = 50 bpm; 5–25 years bradycardia = 50 bpm

inv-04: Left ventricular ejection fraction

Left ventricular ejection fraction (LVEF)< 35%

ContextFDA indication: LVEF < 35% for symptomatic chronic heart failure patients considered for ivabradine

Policy requirementMember must meet LVEF < 35% as part of coverage criteria

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Corlanor (ivabradine) when billed under the pharmacy benefit. Ensure prior authorization is obtained before dispensing; failure to secure authorization may result in claim denial.

Program Type: Commercial/Exchange
Benefit: Pharmacy Benefit
Quantity Limit: Yes — program enforces quantity limits
Contact (All Plans Pharmacy PA): Phone: 877-519-1908; Fax: 855-540-3693

Step Therapy

Step Therapy / Benefit Routing

Step therapy and benefit routing apply. Corlanor is managed under the pharmacy benefit with step therapy requirements and quantity limits; specialty limits do not apply. For members submitting under medical benefit, verify routing — approval is via the pharmacy prior authorization program.

Benefit Routing: Pharmacy Benefit (primary) — Medical Benefit routing only when applicable per site of care
Step Therapy: Step therapy applies prior to approval under the pharmacy program
Specialty Limitations: N/A
Quantity Limits: Enforced under program rules
PA Contacts: Non-Specialty Medications Phone: 800-711-4555; Fax: 844-403-1029

Documentation Required

Required Clinical Documentation

Documentation required at time of prior authorization includes cardiology involvement and objective evidence of resting heart rate, plus medication history and rationale when beta-blocker or standard therapy cannot be used.

Prescriber requirement: Prescriber must be a cardiologist OR a cardiology consult must be submitted
Resting heart rate: For members ≥18 years, resting HR ≥70 bpm; for ages 6 months–17 years, resting HR in age-appropriate abnormal range per appendix
Beta-blocker use: Evidence member is currently receiving a beta-blocker (carvedilol, metoprolol succinate, or bisoprolol) at maximally tolerated age-appropriate doses, OR clinical rationale why a beta-blocker cannot be used
Prior standard therapy: Documentation member received ACE inhibitor, ARB, or ARNI in combination with a beta-blocker, OR clinical rationale why standard-of-care combination cannot be used

Denial Risk

New-to-Plan Treatment Continuity Limitation

New-to-plan continuity: Authorization may be granted for members new to the plan only if they are currently receiving Corlanor; continuity does not apply when product was obtained only as samples or via manufacturer patient assistance programs. Members new to the plan who are not currently receiving Corlanor risk denial.

New-to-plan rule: Authorization may be granted if member is currently receiving Corlanor (documentation required)
Exclusion: Continuity does NOT apply if prior supply was samples or via manufacturer patient assistance program
Denial risk: Members new to plan not already receiving Corlanor or without supporting external documentation are at risk for denial

Background on Ivabradine

Ivabradine (Corlanor) is a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker used to reduce the risk of hospitalization for worsening heart failure in stable, symptomatic patients with chronic heart failure and reduced ejection fraction. The policy requires documentation that patients are in sinus rhythm with an elevated resting heart rate and have received or are intolerant of maximally tolerated beta‑blocker therapy.

The policy's clinical selection criteria reference the FDA‑indicated population: patients with left ventricular ejection fraction < 35% and, for adults, a resting heart rate threshold of ≥70 beats per minute; pediatric age‑based resting heart rate norms are provided in the policy appendix.

OpenPayer

Corlanor (ivabradine) coverage and prior authorization

Coverage Criteria for Corlanor (ivabradine)

Clinical Thresholds and Coding

Provider Actions, Authorization & Documentation

Background on Ivabradine

Definitions and Thresholds