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

The Requirements Checklist to Get Evkeeza (evinacumab-dgnb) Covered by Cigna in Washington

Answer Box: Getting Evkeeza Covered by Cigna in Washington

Fastest path to approval: Gather genetic HoFH confirmation, recent LDL-C levels (≥300 mg/dL while treated), and documented trials of maximally tolerated statin + ezetimibe + PCSK9 inhibitor. Submit Cigna's prior authorization form through their provider portal with specialist attestation. If denied, Washington's external review process provides binding independent review within 30 days. Start today: Contact your lipid specialist to compile clinical documentation and verify current Cigna PA requirements.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: Tracking and Follow-up
  9. Common Denial Prevention Tips
  10. Washington State Appeal Rights
  11. Printable Checklist
  12. Frequently Asked Questions

Who Should Use This Checklist

This comprehensive requirements checklist is designed for patients with homozygous familial hypercholesterolemia (HoFH) and their healthcare teams seeking Cigna coverage for Evkeeza (evinacumab-dgnb) in Washington state.

Use this guide if you:

  • Have confirmed HoFH diagnosis and need Evkeeza therapy
  • Are enrolled in a Cigna health plan (commercial, Medicare Advantage, or Medicaid managed care)
  • Live in Washington or receive care from Washington providers
  • Face prior authorization requirements or coverage denials

Expected outcome: Following this checklist systematically increases your approval chances and ensures you're prepared for Washington's appeals process if needed. Counterforce Health helps patients navigate these complex coverage requirements by turning denials into evidence-backed appeals.

Member & Plan Basics

Coverage Verification Requirements

Before starting your prior authorization, confirm these essential plan details:

Active Coverage Status

  • Verify current Cigna enrollment and effective dates
  • Check that Evkeeza requires prior authorization under your specific plan
  • Confirm whether your plan uses Express Scripts or Accredo for specialty medications

Plan Type Considerations

  • Commercial plans: Full Washington state appeal rights apply
  • Medicare Advantage: Federal and state protections available
  • Self-funded employer plans: May have limited state protections; verify external review availability
  • Medicaid managed care: Additional state fair hearing rights may apply
Note: Contact Cigna member services at the number on your insurance card to verify your specific plan's requirements and formulary status for Evkeeza.

Clinical Criteria Requirements

Primary Indication and Diagnosis

Evkeeza is FDA-approved specifically for HoFH as an adjunct to other LDL-cholesterol lowering therapies. Cigna's coverage policy requires:

Confirmed HoFH Diagnosis

  • Genetic testing showing two pathogenic mutations in LDLR, APOB, PCSK9, or LDLRAP1 genes, OR
  • Clinical criteria: Untreated LDL-C >500 mg/dL or treated LDL-C ≥300 mg/dL with family history

Age Requirements

  • Patient must be ≥5 years old
  • Pediatric dosing based on weight (15 mg/kg every 4 weeks)

Step Therapy Requirements

Mandatory Background Therapy Trials

  • Maximally tolerated statin therapy (unless contraindicated)
  • Ezetimibe trial with documented response/intolerance
  • PCSK9 inhibitor trial (for patients ≥10 years) for ≥8 weeks with inadequate LDL-C reduction

Documentation Requirements

  • Specific medications tried, doses, duration of therapy
  • Reasons for discontinuation (intolerance, contraindication, inadequate response)
  • Current LDL-C levels while on background therapy

Laboratory Thresholds

Recent Lipid Panel Requirements

  • LDL-C measurement within 90 days of PA submission
  • Demonstrated inadequate control (typically ≥70-100 mg/dL) despite maximal background therapy
  • Baseline lipid levels for comparison

Coding and Billing Requirements

ICD-10 Diagnosis Codes

Primary Code Options

  • E78.010 - Homozygous familial hypercholesterolemia (preferred for 2024-2025)
  • E78.01 - Familial hypercholesterolemia (may be accepted by some plans)
Important: Some Cigna plans now require the more specific E78.010 code. Verify current requirements with your plan to avoid claim rejections.

HCPCS and Administration Codes

Drug Code

  • J1305 - Injection, evinacumab-dgnb, 5 mg per billing unit

Administration Codes

  • 96413 - Chemotherapy administration, IV infusion, up to 1 hour
  • 96365 - IV infusion, therapy/prophylaxis, initial, up to 1 hour

Unit Calculations

  • Total dose in mg ÷ 5 = number of J1305 units to bill
  • Example: 70 kg patient × 15 mg/kg = 1,050 mg dose = 210 units

Required Modifiers

  • JZ modifier if reporting no discarded drug from vial (CMS requirement)
  • Verify facility-specific revenue codes with your billing department

Documentation Packet

Provider Letter of Medical Necessity Components

Your specialist must include these elements in their clinical letter:

Patient Information

  • Confirmed HoFH diagnosis with supporting evidence
  • Current age and weight (for dosing calculations)
  • Relevant family history and physical findings

Treatment History

  • Detailed prior medication trials with specific drugs, doses, and durations
  • Reasons for treatment failures or intolerances
  • Current lipid-lowering regimen and response

Clinical Rationale

  • Medical necessity for Evkeeza specifically
  • Treatment goals and expected outcomes
  • Monitoring plan and follow-up schedule

Supporting Evidence

  • Reference to FDA labeling and HoFH treatment guidelines
  • Cite relevant clinical studies if applicable

Required Attachments Checklist

□ Genetic testing results (if available) □ Recent lipid panel (within 90 days) □ Previous medication trial documentation □ Provider credentials (lipid specialist, cardiologist, or endocrinologist) □ Current prescription with accurate dosing □ Insurance card copy □ Prior denial letters (if resubmitting)

Submission Process

Cigna Prior Authorization Form

Form Requirements

  • Use Cigna's current Evkeeza PA form (verify with the source linked)
  • Complete all required fields to avoid automatic rejections
  • Ensure prescriber signature and credentials are clearly documented

Submission Methods (in order of speed)

  1. Cigna provider portal (fastest - 24-72 hour response)
  2. Express Scripts PA portal for specialty medications
  3. Fax submission (verify current fax number with Cigna)
  4. Phone submission for urgent cases

Common Rejection Triggers

Incomplete Information

  • Missing prescriber credentials or specialty designation
  • Incomplete prior therapy documentation
  • Outdated lab values or missing LDL-C levels

Coding Issues

  • Using outdated ICD-10 codes
  • Incorrect dosing calculations
  • Missing or inappropriate procedure codes

Specialty Pharmacy Coordination

Accredo Partnership

Once approved, Evkeeza prescriptions are exclusively managed through Accredo, Cigna's specialty pharmacy partner:

Patient Enrollment Process

  • Accredo contacts patient within 24-48 hours of approval
  • Completes enrollment and benefits verification
  • Coordinates delivery to infusion site

Delivery Coordination

  • Ships directly to licensed healthcare facility
  • Coordinates with infusion center scheduling
  • Provides tracking and delivery confirmation
Tip: Proactively contact your infusion center to coordinate Accredo delivery timing with your scheduled appointments.

After Submission: Tracking and Follow-up

Response Timelines

Standard Review

  • 72 hours for non-urgent requests
  • 24 hours for urgent/expedited requests
  • Requests are deemed approved if Cigna doesn't respond within mandated timeframes

Status Tracking

  • Record confirmation number from submission
  • Check status through Cigna provider portal
  • Follow up if no response within expected timeframe

Approval Documentation

What to Record

  • Authorization number and effective dates
  • Approved quantity and refill limitations
  • Any special conditions or requirements
  • Renewal timeline (typically annual)

Common Denial Prevention Tips

Five Critical Pitfalls and Solutions

Pitfall Prevention Strategy
Incomplete prior therapy documentation Document specific medications, doses, duration, and outcomes for each failed therapy
Missing specialist credentials Ensure PA is submitted by or co-signed by lipid specialist, cardiologist, or endocrinologist
Outdated lab values Submit LDL-C levels within 90 days; include baseline and current values
Incorrect diagnosis coding Use most current ICD-10 code (E78.010) and verify with your specific Cigna plan
Insufficient clinical rationale Include detailed medical necessity explanation specific to patient's HoFH severity

Documentation Best Practices

  • Be specific: Include exact medication names, doses, and trial durations
  • Show progression: Document how LDL-C levels changed with each therapy
  • Cite guidelines: Reference FDA labeling and professional society recommendations
  • Address alternatives: Explain why other HoFH treatments are inadequate or contraindicated

Washington State Appeal Rights

If your initial prior authorization is denied, Washington provides robust appeal protections:

Internal Appeal Process

Timeline and Requirements

  • File written appeal within 180 days of denial
  • Cigna must respond within 30 days (72 hours if expedited)
  • Submit additional clinical evidence and specialist support

Expedited Appeals

  • Available when delay could seriously jeopardize health
  • 72-hour response requirement
  • Can be requested by patient or provider

External Review (IRO)

Washington's Independent Review Organization process provides binding external review:

Key Features

  • File within 180 days of final internal denial
  • Review by independent medical specialists
  • Binding decision on Cigna if overturned
  • No cost to patient

Contact Information

  • Washington Office of the Insurance Commissioner: 1-800-562-6900
  • Consumer advocates can help navigate the appeals process
From our advocates: We've seen many HoFH patients successfully overturn initial Evkeeza denials through Washington's external review process, especially when armed with updated genetic testing and comprehensive documentation of failed prior therapies. The key is submitting complete clinical evidence that clearly demonstrates medical necessity.

Printable Checklist

Pre-Submission Requirements ✓

□ Patient eligibility verified (age ≥5, confirmed HoFH) □ Cigna coverage confirmed (active plan, PA required) □ Specialist involvement (lipid specialist, cardiologist, endocrinologist) □ Genetic testing (if available) □ Recent labs (LDL-C within 90 days) □ Prior therapy documentation (statin, ezetimibe, PCSK9 inhibitor) □ Correct diagnosis code (E78.010 or plan-specific requirement) □ Complete PA form (current version from Cigna) □ Medical necessity letter (comprehensive clinical rationale)

Submission and Follow-up ✓

□ Submit via fastest method (provider portal preferred) □ Record confirmation number and submission date □ Track response timeline (72 hours standard, 24 hours urgent) □ Coordinate with Accredo (if approved) □ Prepare appeal strategy (if denied) □ Document all communications for potential appeals

Frequently Asked Questions

How long does Cigna prior authorization take for Evkeeza in Washington? Standard requests receive responses within 72 hours, urgent requests within 24 hours. If Cigna doesn't respond within these timeframes, the request is deemed approved under Washington law.

What if Evkeeza is not on Cigna's formulary? You can request a formulary exception with medical necessity documentation. Washington law requires insurers to have a clear exception process for non-formulary medications when medically necessary.

Can I request an expedited appeal if denied? Yes, Washington allows expedited appeals when delays could seriously jeopardize your health. These must be decided within 72 hours.

Does step therapy apply if I tried medications outside Washington? Yes, documented therapy trials from other states count toward step therapy requirements. Ensure you have complete records from previous providers.

What's the difference between internal and external appeals? Internal appeals are reviewed by Cigna staff, while external appeals are reviewed by independent medical specialists assigned by Washington state. External review decisions are binding on Cigna.

How much does Evkeeza cost if approved? With Cigna coverage, your cost depends on your plan's specialty drug tier and copay structure. Accredo can help identify copay assistance programs.

What if my employer plan is self-funded? Self-funded ERISA plans may not be subject to Washington state appeal rights. Check with your plan administrator about available appeal processes and external review options.

Can Counterforce Health help with my appeal? Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with payer policies and clinical evidence.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with your insurance plan and consult healthcare providers for medical decisions. For personalized assistance with insurance appeals, contact the Washington Office of the Insurance Commissioner at 1-800-562-6900.

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