By Counterforce Health Team in Evkeeza (evinacumab-dgnb) —

How to Get Evkeeza (Evinacumab) Covered by Cigna in North Carolina: Complete Prior Authorization Guide

Answer Box: Quick Path to Evkeeza Coverage

Evkeeza (evinacumab) requires prior authorization from Cigna in North Carolina. To get approved, you need: (1) confirmed homozygous familial hypercholesterolemia diagnosis with genetic testing or clinical criteria, (2) documentation of maximally tolerated statin, ezetimibe, and PCSK9 inhibitor trials (if age ≥10), and (3) prescription from a lipid specialist. Submit through Cigna's provider portal or Accredo specialty pharmacy. Standard review takes 72 hours; expedited review 24 hours. If denied, use Cigna's internal appeal process, then North Carolina's Smart NC external review program.

Start today: Contact your prescribing specialist to gather genetic test results, lipid panels, and prior therapy documentation.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization
  5. Follow-Up and Timeline
  6. If You're Asked for More Information
  7. If Your Request is Denied
  8. Renewal and Re-Authorization
  9. Printable Checklist
  10. Frequently Asked Questions

What This Guide Covers

This guide helps North Carolina patients and their healthcare providers navigate Cigna's prior authorization process for Evkeeza (evinacumab-dgnb), a specialized treatment for homozygous familial hypercholesterolemia (HoFH).

Evkeeza is an expensive specialty medication—with costs around $450,000 annually—that requires careful documentation to demonstrate medical necessity. We'll walk you through exactly what Cigna requires, how to submit a complete request, and what to do if you face a denial.

Who this helps:

  • Patients diagnosed with HoFH who need Evkeeza coverage
  • Healthcare providers submitting prior authorizations
  • Families navigating insurance appeals in North Carolina

Before You Start: Verify Your Coverage

Check Your Plan Type

First, confirm you have a state-regulated Cigna plan that falls under North Carolina's external review protections. Self-funded employer plans may have different appeal rights.

Call Cigna member services at the number on your insurance card to verify:

  • Your specific plan type
  • Whether Evkeeza requires prior authorization
  • If it's covered under medical or pharmacy benefits
  • Your formulary tier for specialty medications

Confirm Specialty Pharmacy Requirements

Most Cigna plans require specialty medications like Evkeeza to go through Accredo, Cigna's specialty pharmacy partner. Verify this requirement early, as it affects how you submit your prior authorization.

Coverage at a Glance: Evkeeza with Cigna in NC

Requirement Details Where to Verify
Prior Authorization Yes, required for all plans Cigna Coverage Policy
Age Requirement ≥5 years old FDA label, Cigna policy
Specialist Required Lipidologist, cardiologist, or endocrinologist Cigna policy
Diagnosis Code E78.01 (Familial hypercholesterolemia) ICD-10 documentation
Prior Therapy PCSK9 inhibitor trial required if ≥10 years Cigna policy (updated March 2023)
Review Timeline 72 hours standard, 24 hours expedited Cigna provider resources

Gather Required Documentation

Counterforce Health helps patients and providers compile the exact evidence needed for complex specialty drug approvals like Evkeeza. Their platform identifies specific payer requirements and drafts targeted appeals using the right clinical citations and procedural details.

Essential Documents for Cigna

1. Diagnosis Confirmation

  • Genetic testing results showing pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Alternative: Clinical phenotype documentation with LDL-C ≥400 mg/dL and family history

2. Recent Laboratory Results

  • Lipid panel within the past 3 months
  • LDL-C levels demonstrating inadequate control
  • Weight documentation for dosing calculations (15 mg/kg monthly)

3. Prior Therapy Documentation

  • For patients ≥10 years: Evidence of PCSK9 inhibitor trial with inadequate response
  • For patients 5-9 years: Prior therapy documentation helpful but not required (policy updated March 2023)
  • Statin and ezetimibe trial records showing maximum tolerated doses

4. Specialist Consultation Notes

  • Prescription must come from a lipidologist, cardiologist, or endocrinologist
  • Clinical rationale for Evkeeza therapy
  • Treatment goals and monitoring plan

Clinician Corner: Medical Necessity Letter Checklist

For Healthcare Providers: Your medical necessity letter should address:Confirmed HoFH diagnosis (genetic or clinical criteria)Current LDL-C levels despite maximum tolerated therapyPrior PCSK9 inhibitor trial and outcome (if applicable)Clinical rationale for Evkeeza based on FDA labelingDosing plan (15 mg/kg IV monthly) and monitoring strategyPatient's functional status and treatment goals

Submit Your Prior Authorization

Step-by-Step Submission Process

1. Choose Your Submission Method

  • Cigna Provider Portal (fastest for in-network providers)
  • Accredo's electronic prior authorization system for specialty pharmacy
  • Phone: 1-800-882-4462 for urgent requests

2. Complete Required Forms

  • Use Cigna's HoFH-specific prior authorization form
  • Attach all supporting documentation listed above
  • Include prescriber attestation and clinical justification

3. Submit Complete Request Packet Your submission should include:

  • ✓ Completed PA form with all fields
  • ✓ Genetic testing results or clinical phenotype documentation
  • ✓ Recent lipid panel (within 3 months)
  • ✓ Prior therapy records (especially PCSK9 inhibitor trial if ≥10 years)
  • ✓ Specialist consultation notes
  • ✓ Medical necessity letter
  • ✓ Patient demographics and insurance information

4. Request Confirmation Get a reference number and confirmation that your submission was received. Document the date and representative name.

Follow-Up and Timeline

Expected Processing Times

  • Standard review: 72 hours from complete submission
  • Expedited review: 24 hours for urgent medical needs
  • Incomplete submissions: May take 5-10 business days while additional information is requested

When to Follow Up

Day 3: If you haven't received a decision on a standard review Day 1: For expedited reviews that haven't been processed

Sample Follow-Up Script:

"I'm calling about prior authorization request #[reference number] for Evkeeza submitted on [date]. Can you provide a status update and let me know if any additional information is needed?"

What Speeds Up Decisions

  • Complete documentation on first submission
  • Electronic submission through provider portal
  • Clear medical necessity justification
  • Specialist prescription with detailed clinical notes

If You're Asked for More Information

Cigna may request additional clinical information, especially for complex HoFH cases. Common requests include:

Additional Labs or Imaging

  • Cardiovascular imaging showing atherosclerotic disease
  • Additional lipid measurements over time
  • Liver function tests if relevant to prior therapy intolerance

Enhanced Clinical Justification

  • More detailed prior therapy trial documentation
  • Specialist consultation notes with specific treatment rationale
  • Family history documentation supporting HoFH diagnosis

Peer-to-Peer Review If requested, your prescribing physician can participate in a peer-to-peer review with Cigna's medical director. This is often helpful for complex cases where clinical judgment is key.

If Your Request is Denied

Understanding Common Denial Reasons

Denial Reason How to Address
"Diagnosis not confirmed" Submit genetic testing results or comprehensive clinical phenotype documentation
"Prior therapy not documented" Provide detailed PCSK9 inhibitor trial records (if ≥10 years)
"Not medically necessary" Enhanced specialist letter with treatment goals and clinical rationale
"Age criteria not met" Verify patient is ≥5 years old with documentation

Cigna Internal Appeal Process

Timeline: You have 180 calendar days from the denial notice to file your first-level appeal.

How to File:

  1. Complete Cigna's Customer Appeal Request form
  2. Include the denial letter and supporting documentation
  3. Submit via Cigna member portal or mail to address on denial letter
  4. Request expedited review if medically urgent

Processing Time: Cigna will issue a decision within 30 calendar days for medical necessity appeals.

North Carolina External Review

If Cigna upholds the denial after internal appeals, you can request an independent review through Smart NC, North Carolina's external review program.

Contact Smart NC:

  • Phone: 1-855-408-1212
  • Submit Request for Assistance form with supporting documents
  • Timeline: You have 120 days from Cigna's final denial to request external review

The external review is conducted by an Independent Review Organization (IRO) and is binding on Cigna. Many specialty drug denials are overturned through this process when proper clinical evidence is provided.

From Our Advocates: "We've seen HoFH patients successfully overturn initial denials by providing comprehensive genetic testing documentation alongside detailed prior therapy records. The key is showing you meet both the clinical criteria and have tried appropriate alternatives. Don't give up after the first denial—the appeals process exists for exactly these complex cases."

Renewal and Re-Authorization

Evkeeza typically requires annual re-authorization with Cigna. Start the renewal process 60-90 days before your current authorization expires.

Renewal Documentation

  • Updated lipid panel showing current LDL-C levels
  • Treatment response documentation
  • Continued specialist oversight confirmation
  • Any changes in clinical status or concurrent medications

Calendar reminder: Set a recurring reminder to begin renewal paperwork 90 days before expiration to avoid treatment interruptions.

Printable Checklist

Before Submitting Evkeeza PA to Cigna:

Patient Information:

  • ☐ Cigna member ID and plan details verified
  • ☐ Age ≥5 years documented
  • ☐ North Carolina residency confirmed for appeal rights

Clinical Documentation:

  • ☐ HoFH diagnosis confirmed (genetic testing preferred)
  • ☐ Recent lipid panel (within 3 months)
  • ☐ Prior PCSK9 inhibitor trial documented (if age ≥10)
  • ☐ Maximum tolerated statin/ezetimibe trials recorded
  • ☐ Specialist consultation notes included

Submission:

  • ☐ Complete PA form with all fields
  • ☐ Medical necessity letter from specialist
  • ☐ All supporting documents attached
  • ☐ Submission method confirmed (portal vs. phone)
  • ☐ Reference number obtained and documented

Frequently Asked Questions

How long does Cigna prior authorization take for Evkeeza in North Carolina? Standard review takes 72 hours from complete submission. Expedited review for urgent cases takes 24 hours.

What if Evkeeza is non-formulary on my Cigna plan? You can request a formulary exception with clinical justification. The process is similar to prior authorization but may require additional documentation of medical necessity.

Can I request an expedited appeal if denied? Yes, if there's medical urgency. Contact Cigna member services to request expedited internal appeal, then Smart NC for expedited external review if needed.

Does step therapy apply if I tried medications outside North Carolina? Yes, prior therapy documentation from any location is acceptable as long as it's properly documented by a healthcare provider.

What's the difference between medical and pharmacy benefit coverage? Evkeeza administered in a clinic typically falls under medical benefits, while home infusion may be pharmacy benefits. This affects your copay and prior authorization process.

How much does Evkeeza cost with Cigna coverage? Costs vary by plan, but specialty medications typically have higher copays. Check with Cigna about your specific out-of-pocket costs and ask about manufacturer copay assistance programs.

What if my employer plan is self-funded? Self-funded plans may not be subject to North Carolina's external review process. Check with your HR department about appeal rights and procedures.

Can I switch to a different specialty pharmacy? Cigna typically requires use of Accredo for specialty medications. Switching may require additional approvals and could delay treatment.

For patients and providers navigating complex insurance approvals, Counterforce Health specializes in turning denials into successful appeals by identifying specific payer requirements and drafting evidence-backed responses. Their platform helps streamline the prior authorization process for specialty medications like Evkeeza.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and should not replace professional medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with Cigna and consult with your healthcare provider about treatment decisions. For additional help with insurance appeals in North Carolina, contact Smart NC at 1-855-408-1212.

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