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

How to Get Evkeeza (evinacumab-dgnb) Covered by UnitedHealthcare in Washington: Complete Prior Authorization Guide

Quick Answer: Getting Evkeeza Covered in Washington

Evkeeza (evinacumab-dgnb) requires prior authorization from UnitedHealthcare OptumRx with no step therapy requirements for homozygous familial hypercholesterolemia (HoFH). Submit PA documentation including HoFH diagnosis (genetic confirmation or clinical phenotype), maximally tolerated lipid-lowering therapy failures, and specialist prescription. If denied, Washington's robust consumer protections allow internal appeals (180 days), then external review via Independent Review Organizations (IRO) through the Office of the Insurance Commissioner at 1-800-562-6900. The IRO process is free, binding on UnitedHealthcare, and has strong overturn rates for rare disease cases.

First step today: Gather HoFH documentation and submit PA via UnitedHealthcare Provider Portal or call 888-397-8129.

Table of Contents

  1. Why Washington State Rules Matter
  2. UnitedHealthcare Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Washington's Step Therapy Protections
  5. Appeals Process: Internal to External Review
  6. Common Denial Reasons & Solutions
  7. Scripts & Templates
  8. When to Escalate to State Regulators
  9. Cost Support Options
  10. FAQ

Why Washington State Rules Matter

Washington state provides some of the strongest consumer protections for insurance denials in the nation. Unlike self-funded ERISA plans that follow federal rules, fully insured UnitedHealthcare plans in Washington must comply with state regulations including:

  • External review rights under RCW 48.43.535 with binding Independent Review Organization decisions
  • Step therapy exceptions under RCW 48.43.420 for medical necessity overrides
  • Strict timelines for insurer responses (1 business day urgent, 3 days standard)
  • Consumer advocacy through the Office of the Insurance Commissioner

These protections apply to UnitedHealthcare commercial and ACA marketplace plans. Medicare Advantage follows federal CMS processes, while self-funded employer plans are governed by ERISA.

Note: Verify your plan type using your member ID card or UnitedHealthcare Provider Portal. Washington state protections don't apply to self-funded ERISA plans.

UnitedHealthcare Prior Authorization Requirements

Coverage Criteria for Evkeeza

UnitedHealthcare OptumRx lists Evkeeza under prior authorization select drugs effective January 1, 2025 with these requirements:

Requirement Details Documentation Needed
Indication HoFH in patients ≥5 years Clinical or genetic HoFH confirmation
Prior Therapy Maximally tolerated lipid-lowering therapy Treatment history with statins, ezetimibe, PCSK9 inhibitors
Prescriber Specialist (typically cardiologist/endocrinologist) Provider credentials
Step Therapy None specified for HoFH N/A
Reauthorization Subject to change (OptumRx reducing reauth requirements) Periodic clinical updates

Submission Process

Online: UnitedHealthcare Provider Portal → Prior Authorization and Notification tool Phone: 888-397-8129 Timeline: Standard PA decisions within 15 business days; expedited within 72 hours for urgent cases

Step-by-Step: Fastest Path to Approval

1. Confirm HoFH Diagnosis Documentation

Who: Prescribing physician What: Genetic testing results showing pathogenic mutations OR clinical phenotype (LDL-C >500 mg/dL despite maximal therapy, family history, physical findings) Timeline: Gather before PA submission

2. Document Prior Lipid-Lowering Therapy

Who: Clinic staff What: Treatment history showing:

  • High-intensity statin trial (unless contraindicated)
  • Ezetimibe trial
  • PCSK9 inhibitor trial (evolocumab/alirocumab)
  • Reasons for failure/intolerance Timeline: Include in PA packet

3. Submit Prior Authorization

Who: Provider or authorized staff What: Complete PA form via portal or phone Include: HoFH diagnosis, prior therapy documentation, current LDL-C levels, treatment goals Timeline: Allow 15 business days for decision

4. Monitor Decision

Who: Clinic staff What: Check portal or call for PA status Timeline: Follow up if no response within 10 business days

5. If Approved: Coordinate Infusion

Who: Clinic and patient What: Schedule IV infusion (15 mg/kg every 4 weeks) Timeline: Begin treatment per physician orders

6. If Denied: File Internal Appeal

Who: Provider with patient consent What: Submit appeal with additional clinical evidence Timeline: Within 180 days of denial per Washington state law

7. If Internal Appeal Denied: Request External Review

Who: Patient or provider What: File IRO request through Washington OIC Timeline: Within 120-180 days of final internal denial

From our advocates: "HoFH cases often get approved on appeal when genetic testing clearly confirms the diagnosis. We've seen success when providers emphasize that Evkeeza works regardless of LDL receptor function, making it uniquely appropriate for true HoFH patients who don't respond adequately to other therapies."

Washington's Step Therapy Protections

While Evkeeza doesn't have explicit step therapy requirements, Washington's RCW 48.43.420 provides strong protections if any are imposed:

Exception Criteria (Any One Applies)

  • Required drug is contraindicated or likely to cause adverse reaction
  • Required drug is expected to be ineffective based on patient characteristics
  • Patient previously tried the required drug or same class with ineffectiveness or adverse effects
  • Required drug would decrease functional ability in daily activities
  • Patient has positive therapeutic outcome on requested drug and switching would cause harm

Timeline Requirements

  • Urgent requests: 1 business day response
  • Standard requests: 3 business days response
  • No response: Request automatically granted

Documentation Support

Use the Washington Step Therapy Exception Cover Sheet with clinical rationale for any step therapy challenges.

Appeals Process: Internal to External Review

Internal Appeals (Required First Step)

Timeline: File within 180 days of denial Response time: 30 days standard, 72 hours expedited Documentation: Include all clinical evidence, specialist letters, treatment history

Submit to: UnitedHealthcare appeals department via member portal or written request

External Review (Washington State IRO Process)

When eligible: After final internal appeal denial Timeline: File within 120-180 days of final internal denial Cost: Free to patient Decision: Binding on UnitedHealthcare

Process:

  1. Contact Washington Office of Insurance Commissioner at 1-800-562-6900
  2. Request external review form or file online
  3. OIC assigns certified Independent Review Organization
  4. IRO reviews case with medical specialists
  5. Decision within 30 days (72 hours expedited)

Overturn rates: Approximately 40% nationally, higher for well-documented rare disease cases

Required Documentation for Appeals

  • Original denial letter
  • Complete medical records
  • HoFH genetic testing or clinical confirmation
  • Prior therapy trials and outcomes
  • Current lipid panel results
  • Specialist treatment recommendations
  • FDA labeling and clinical guidelines supporting use

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
HoFH not confirmed Provide genetic testing or clinical phenotype criteria Pathogenic mutations OR LDL-C >500 mg/dL with family history
Insufficient prior therapy Document maximally tolerated trials Treatment records showing statin, ezetimibe, PCSK9 inhibitor attempts
Age restriction Confirm FDA approval ≥5 years Birth certificate, current age documentation
Site of care issues Clarify infusion center capabilities Facility accreditation, infusion protocols
Medical necessity Emphasize HoFH severity and ANGPTL3 mechanism Current LDL-C levels, cardiovascular risk, unique mechanism of action

Scripts & Templates

Patient Phone Script for UnitedHealthcare

"Hello, I'm calling about prior authorization for Evkeeza for homozygous familial hypercholesterolemia. My member ID is [number]. My doctor submitted the PA on [date] and I need to check the status. This is for a rare genetic condition and I've tried other cholesterol medications without success."

Provider Peer-to-Peer Request Script

"I'm requesting a peer-to-peer review for Evkeeza (evinacumab) for my patient with genetically confirmed HoFH. This patient has LDL cholesterol over [level] despite maximal tolerated therapy including high-intensity statins and PCSK9 inhibitors. Evkeeza's unique ANGPTL3 inhibition mechanism is specifically indicated for HoFH regardless of LDL receptor function."

Medical Necessity Letter Template

[Date]
[UnitedHealthcare Medical Director]

RE: Medical Necessity for Evkeeza (evinacumab-dgnb)
Patient: [Name], DOB: [Date], Member ID: [Number]

This letter supports the medical necessity of Evkeeza for my patient with homozygous familial hypercholesterolemia (HoFH).

DIAGNOSIS: HoFH confirmed by [genetic testing/clinical criteria]
CURRENT LDL-C: [level] mg/dL despite maximal therapy

PRIOR TREATMENTS AND OUTCOMES:
- High-intensity statin: [drug, dose, duration, outcome]
- Ezetimibe: [dose, duration, outcome]  
- PCSK9 inhibitor: [drug, dose, duration, outcome]

CLINICAL RATIONALE: 
Evkeeza (evinacumab-dgnb) is FDA-approved specifically for HoFH and works through ANGPTL3 inhibition, independent of LDL receptor function. This mechanism is uniquely appropriate for HoFH patients who have defective or absent LDL receptors.

TREATMENT GOALS: Reduce cardiovascular risk through LDL-C lowering in this high-risk genetic condition.

Please approve this medically necessary treatment.

Sincerely,
[Provider name, credentials]

When to Escalate to State Regulators

Contact the Washington Office of Insurance Commissioner if:

  • UnitedHealthcare misses appeal deadlines
  • Denials appear to ignore clinical evidence
  • Step therapy is inappropriately applied
  • External review rights are not honored

Contact Information:

  • Phone: 1-800-562-6900 (Consumer Advocacy)
  • Online: File complaint at insurance.wa.gov
  • Services: Template appeal letters, external review forms, complaint investigation

The OIC actively assists with rare disease medication appeals and has authority to investigate unfair claim practices.

Cost Support Options

Manufacturer Support

Regeneron: Patient assistance programs and copay support Eligibility: Income-based for uninsured/underinsured patients Contact: Verify current programs at Regeneron.com

Foundation Grants

  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation
  • Patient Access Network Foundation

State Programs

Washington Apple Health (Medicaid) may provide coverage for eligible patients. Contact Washington Health Benefit Exchange for enrollment assistance.

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes for specialty medications like Evkeeza. Our platform analyzes denial letters, identifies specific coverage criteria, and generates targeted appeals with evidence-backed clinical arguments. By understanding payer-specific workflows and state protections, we help turn insurance denials into successful approvals. Learn more about our prior authorization support services.

FAQ

Q: How long does UnitedHealthcare prior authorization take for Evkeeza in Washington? A: Standard PA decisions take up to 15 business days. Expedited reviews for urgent cases are completed within 72 hours. Washington state law requires insurers to respond within specified timeframes or automatically approve requests.

Q: What if Evkeeza is not on UnitedHealthcare's formulary? A: Non-formulary medications can still be covered through the prior authorization process with medical necessity documentation. Washington's external review process provides additional recourse if initially denied.

Q: Can I request an expedited appeal if my health is deteriorating? A: Yes. Washington allows expedited appeals within 72 hours if your health is in jeopardy. Document the urgent nature of your condition and cardiovascular risk from uncontrolled HoFH.

Q: Does step therapy apply if I failed other treatments outside Washington? A: Treatment failures from other states or insurance plans count toward meeting prior therapy requirements. Document all previous trials with medical records.

Q: What's the difference between internal and external appeals? A: Internal appeals are reviewed by UnitedHealthcare staff. External appeals are reviewed by independent medical experts through Washington's IRO process and are binding on the insurer.

Q: How much does Evkeeza cost without insurance? A: The wholesale acquisition cost is approximately $450,000 annually for an average adult, though actual costs vary by weight and negotiations. Patient assistance programs may help with costs.

Q: What documentation is most important for HoFH approval? A: Genetic testing confirming pathogenic mutations is strongest, followed by clinical phenotype documentation (LDL-C >500 mg/dL, family history, physical findings) and comprehensive prior therapy records.

Q: Can my primary care doctor prescribe Evkeeza? A: While technically possible, UnitedHealthcare typically requires specialist prescribing (cardiologist, endocrinologist, or lipid specialist) for rare disease medications like Evkeeza.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For assistance with complex prior authorization cases, Counterforce Health provides specialized support for patients and clinicians navigating insurance approval processes.

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