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

Do You Qualify for Evkeeza Coverage by UnitedHealthcare in New Jersey? Decision Tree & Next Steps

Answer Box: Getting Evkeeza Covered by UnitedHealthcare in New Jersey

To qualify for Evkeeza (evinacumab-dgnb) coverage by UnitedHealthcare in New Jersey, you need: (1) confirmed homozygous familial hypercholesterolemia diagnosis with genetic testing or clinical criteria, (2) documented failure or intolerance to maximally tolerated statin + ezetimibe + PCSK9 inhibitor therapy, and (3) current LDL cholesterol levels ≥300 mg/dL despite treatment. First step: gather your genetic testing results, recent LDL-C labs, and complete medication trial records. Submit prior authorization through your prescriber or UnitedHealthcare provider portal. If denied, New Jersey's IHCAP external review program provides binding decisions within 45 days.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. Likely Eligible: Document Checklist
  4. Possibly Eligible: Tests to Request
  5. Not Yet Eligible: Alternative Options
  6. If Denied: Appeal Path Chooser
  7. New Jersey External Review Process
  8. Coverage Requirements at a Glance
  9. Common Denial Reasons & Solutions
  10. Frequently Asked Questions

How to Use This Decision Tree

This guide helps patients and clinicians navigate UnitedHealthcare's prior authorization requirements for Evkeeza (evinacumab-dgnb) in New Jersey. Start with the eligibility triage below to determine your current status, then follow the appropriate pathway. Each section provides specific documentation requirements and next steps.

Evkeeza is an ANGPTL3 monoclonal antibody that costs approximately $450,000 annually and requires intravenous administration every 4 weeks at 15 mg/kg. Given the high cost and specialized nature of this therapy, UnitedHealthcare requires comprehensive documentation before approval.

Eligibility Triage: Do You Qualify?

Step 1: Diagnosis Confirmation

Do you have confirmed homozygous familial hypercholesterolemia (HoFH)?

✅ Yes, if you have:

  • Genetic testing showing two mutant alleles in LDLR, ApoB, PCSK9, or LDLRAP1 genes, OR
  • Clinical criteria: untreated LDL-C >500 mg/dL or treated LDL-C ≥300 mg/dL PLUS cutaneous/tendon xanthomas before age 10

❌ No, if you have:

  • Only heterozygous FH
  • High cholesterol without genetic confirmation
  • Missing diagnostic documentation

Step 2: Prior Therapy Requirements

Have you tried and failed maximally tolerated background therapy?

✅ Yes, if you've documented failure, intolerance, or contraindication to:

  • High-intensity statin (atorvastatin 40-80mg or rosuvastatin 20-40mg)
  • Ezetimibe 10mg daily
  • PCSK9 inhibitor (evolocumab or alirocumab)

❌ No, if you:

  • Haven't tried all three medication classes
  • Lack documentation of specific reasons for discontinuation
  • Haven't been on therapy for adequate duration (typically 6-12 weeks each)

Step 3: Laboratory Requirements

Do you have recent LDL cholesterol documentation?

✅ Yes, if you have:

  • Baseline (pre-treatment) LDL-C levels
  • Current LDL-C levels ≥300 mg/dL despite maximally tolerated therapy
  • Laboratory results dated within the last 3 months

❌ No, if you're missing:

  • Recent LDL-C measurements
  • Baseline cholesterol levels
  • Proper laboratory documentation with dates

Likely Eligible: Document Checklist

If you answered "Yes" to all three eligibility questions, gather these documents for your prior authorization submission:

Required Clinical Documentation

  • Genetic testing report confirming HoFH diagnosis
  • Complete lipid panel with LDL-C ≥300 mg/dL (within 3 months)
  • Baseline (untreated) LDL-C levels
  • Clinical notes from cardiologist, endocrinologist, or lipid specialist
  • Documentation of cutaneous or tendon xanthomas (if applicable)

Prior Therapy Documentation

  • Detailed medication history table showing:
    • Specific statin tried (drug name, dose, duration)
    • Reason for discontinuation (failure/intolerance/contraindication)
    • Ezetimibe trial details
    • PCSK9 inhibitor trial documentation
  • Pharmacy records or prescription history
  • Clinical notes documenting adverse effects or contraindications

Submission Requirements

  • Prior authorization form completed by prescribing specialist
  • Patient demographics and UnitedHealthcare member ID
  • Proposed treatment plan (15 mg/kg IV every 4 weeks)
  • Site of care documentation (infusion center details)
Tip: Submit all documents simultaneously to avoid delays. UnitedHealthcare typically responds to complete prior authorization requests within 5-15 business days.

Possibly Eligible: Tests to Request

If you're missing key documentation, request these tests and evaluations:

Diagnostic Testing Needed

  1. Genetic Testing: Request comprehensive FH genetic panel testing LDLR, ApoB, PCSK9, and LDLRAP1 genes
  2. Complete Lipid Panel: Fasting LDL-C, total cholesterol, HDL-C, triglycerides
  3. Specialist Consultation: Referral to cardiologist or lipid specialist for HoFH confirmation

Timeline for Reapplication

  • Genetic testing results: 2-4 weeks
  • Specialist appointment: 2-8 weeks depending on availability
  • Complete documentation assembly: 1-2 weeks
  • Total timeline: 6-12 weeks before resubmission

What to Track

  • Document all medication trials with specific start/stop dates
  • Record LDL-C levels at baseline and after each therapy change
  • Note any adverse effects or contraindications to prior medications
  • Maintain communication with specialist about treatment goals

Not Yet Eligible: Alternative Options

If you don't currently meet Evkeeza criteria, discuss these alternatives with your specialist:

Alternative Therapies

  1. PCSK9 Inhibitors: Evolocumab (Repatha) or alirocumab (Praluent) - typically require prior authorization but have less stringent criteria
  2. Lomitapide (Juxtapid): Oral therapy for HoFH with different mechanism of action
  3. LDL Apheresis: Extracorporeal cholesterol removal procedure
  4. Maximized Conventional Therapy: Optimize statin and ezetimibe dosing

Exception Request Strategy

Even if you don't meet standard criteria, you may request an exception if:

  • You have documented contraindications to required prior therapies
  • You've experienced severe adverse effects to alternative treatments
  • Your clinical presentation is particularly severe or urgent

Work with Counterforce Health to develop a comprehensive exception request that addresses UnitedHealthcare's specific denial reasons with targeted clinical evidence and guideline citations.

If Denied: Appeal Path Chooser

UnitedHealthcare denials can be appealed through multiple pathways in New Jersey:

Level 1: Internal Appeal (First Step)

Timeline: Submit within 180 days of denial Process:

  • Complete UnitedHealthcare internal appeal form
  • Include additional clinical documentation
  • Request peer-to-peer review if available
  • Response time: 15-30 days for standard review

Level 2: Peer-to-Peer Review

When to use: For complex clinical cases where additional explanation may help Timeline: Request within 24 hours of initial denial Process: Your prescriber discusses the case directly with UnitedHealthcare medical director

Level 3: Expedited Internal Appeal

When to use: If delay would jeopardize your health Timeline: 72 hours for response Requirements: Medical urgency documentation

New Jersey External Review Process

If UnitedHealthcare upholds their denial after internal appeals, New Jersey's Independent Health Care Appeals Program (IHCAP) provides binding external review.

IHCAP Process Overview

New Jersey contracts with Maximus Federal Services to administer external reviews. This process is free to patients - insurers pay all costs.

Filing Requirements

  • Complete internal appeals process first
  • Submit within 4 months (180 days) of final internal denial
  • Include External Appeal Application
  • Provide medical records and denial letters
  • Submit to Maximus (not directly to NJ Department of Banking and Insurance)

Timeline

  • Preliminary review: 5 business days to accept or reject appeal
  • Standard review: 45 calendar days for final decision
  • Expedited review: 48 hours for urgent cases

Authority

IHCAP decisions are binding on UnitedHealthcare. If the external reviewer determines Evkeeza is medically necessary, UnitedHealthcare must provide coverage within 10 business days.

For questions about the IHCAP process, contact the consumer hotline at 1-888-393-1062.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans Complete PA form by specialist UHC Provider Portal
Diagnosis Confirmed HoFH Genetic testing or clinical criteria FDA Label
Prior Therapy Statin + ezetimibe + PCSK9i failure Detailed medication history Plan formulary
LDL-C Levels ≥300 mg/dL on treatment Recent lipid panel (≤3 months) Clinical guidelines
Prescriber Specialist required Cardiologist/endocrinologist notes PA criteria
Site of Care IV infusion facility Infusion center verification Administration requirements

Common Denial Reasons & Solutions

Denial Reason How to Fix Documents to Include
Missing genetic confirmation Submit genetic testing Complete FH gene panel results
Inadequate prior therapy Document all medication trials Pharmacy records, clinical notes
Insufficient LDL-C documentation Provide recent lab results Lipid panel within 3 months
Non-specialist prescriber Transfer to appropriate specialist Consultation notes from cardiologist
Missing baseline labs Submit pre-treatment values Historical laboratory results
Incomplete medication history Detail each therapy trial Start/stop dates, doses, reasons
From our advocates: We've seen cases where patients were initially denied because their genetic testing was done years ago. Including a current specialist note confirming the ongoing relevance of the genetic diagnosis, along with recent family history updates, helped establish medical necessity during the appeal process.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Evkeeza? Standard prior authorization review takes 5-15 business days for complete submissions. Incomplete submissions may take longer due to requests for additional information.

What if Evkeeza isn't on my UnitedHealthcare formulary? Evkeeza may require coverage through medical benefit rather than pharmacy benefit. Your prescriber should submit prior authorization through the appropriate channel based on your specific plan.

Can I get expedited approval if my condition is urgent? Yes, if your physician documents that delay would jeopardize your health, you can request expedited review with 72-hour response time.

Does UnitedHealthcare require step therapy for Evkeeza? Yes, you must demonstrate failure, intolerance, or contraindication to conventional lipid-lowering therapies including statins, ezetimibe, and PCSK9 inhibitors.

What happens if I move from New Jersey while on Evkeeza? Coverage requirements may change based on your new state's regulations. Contact UnitedHealthcare member services to understand any differences in prior authorization requirements.

How much will I pay for Evkeeza with UnitedHealthcare coverage? Your out-of-pocket cost depends on your specific plan's specialty drug tier and annual out-of-pocket maximum. Contact member services for your specific copay or coinsurance amounts.

Cost Assistance and Support

Even with UnitedHealthcare coverage, Evkeeza's high cost may result in significant out-of-pocket expenses. Explore these assistance options:

  • Regeneron MyChoice Patient Support Program: May provide copay assistance for eligible patients
  • Foundation grants: Organizations like Patient Advocate Foundation offer assistance for rare disease medications
  • State pharmaceutical assistance programs: New Jersey may have additional support programs for residents

For comprehensive assistance with prior authorization appeals and coverage denials, Counterforce Health specializes in turning insurance denials into evidence-backed appeals, helping patients navigate complex prior authorization requirements for specialty medications like Evkeeza.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Prior authorization requirements may vary by specific UnitedHealthcare plan and can change over time. Always verify current requirements with your insurance plan and consult with your healthcare provider regarding appropriate treatment options. For assistance with insurance appeals and coverage issues, contact the New Jersey Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

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