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

How to Get Evkeeza (evinacumab-dgnb) Covered by UnitedHealthcare in Florida: Prior Authorization Guide & Appeal Process

Answer Box: Getting Evkeeza Covered by UnitedHealthcare in Florida

Evkeeza (evinacumab-dgnb) requires prior authorization from UnitedHealthcare in Florida. To get approved: (1) Confirm your HoFH diagnosis with genetic testing or clinical criteria, (2) Document failure/intolerance of background therapies (statins, ezetimibe, PCSK9 inhibitors), and (3) Submit through the UnitedHealthcare Provider Portal with complete medical records. If denied, you have 180 days to appeal internally, then can request external review through Florida's Department of Financial Services. Start by gathering your genetic test results, treatment history, and current LDL-C levels.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Process
  5. Cost-Sharing Considerations
  6. Submission Process
  7. Appeals Playbook for Florida
  8. Common Denial Reasons & Solutions
  9. Patient Support & Cost Assistance
  10. FAQ

Plan Types & Coverage Implications

UnitedHealthcare offers several plan types in Florida, each with different implications for specialty drug coverage like Evkeeza:

HMO Plans: Lower premiums but require primary care physician referrals and strict network adherence. Specialty drugs must be obtained through network providers, which can limit infusion site options.

PPO Plans: Higher flexibility with out-of-network coverage (at higher cost). Better for accessing specialized lipid clinics or infusion centers that may not be in smaller networks.

EPO Plans: Balance between HMO and PPO with larger networks than HMOs but no out-of-network coverage except emergencies. Good middle-ground option for specialty care access.

All plan types require the same prior authorization process for Evkeeza, but network restrictions may affect where you can receive infusions.

Formulary Status & Tier Placement

Evkeeza is classified as a specialty medication requiring prior authorization across all UnitedHealthcare Florida plans. It's typically placed on the highest specialty tier due to its cost (approximately $450,000 annually) and limited indication for homozygous familial hypercholesterolemia (HoFH).

The drug is covered under the medical benefit rather than pharmacy benefit, meaning it's administered by healthcare providers rather than dispensed for home use.

Prior Authorization Requirements

UnitedHealthcare requires comprehensive documentation to approve Evkeeza coverage:

Coverage Requirements Table

Requirement What It Means Documentation Needed Source
HoFH Diagnosis Confirmed homozygous familial hypercholesterolemia Genetic testing or clinical criteria UHC Policy
Age ≥5 years FDA-approved age range Medical records UHC Policy
Background therapy Ezetimibe with maximally tolerated statin Treatment history UHC Policy
PCSK9 status Tried/failed or contraindicated Medical records UHC Policy
Specialist care Lipid specialist involvement Prescriber credentials UHC Policy

HoFH Diagnosis Criteria

Genetic Confirmation (preferred):

  • Bi-allelic pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Two or more variants at different loci

Clinical Criteria (if genetic testing unavailable):

  • Untreated LDL-C >400 mg/dL
  • PLUS either:
    • Xanthomas before age 10
    • Evidence of familial hypercholesterolemia in one parent

Specialty Pharmacy Process

Evkeeza is distributed through OptumRx, UnitedHealthcare's specialty pharmacy network in Florida. The process involves:

  1. Prescription Submission: Provider submits prescription and prior authorization through OptumRx specialty pharmacy
  2. Benefit Verification: OptumRx confirms coverage and patient responsibility
  3. Coordination: OptumRx coordinates with infusion provider for scheduling
  4. Delivery: Medication shipped directly to infusion center (not home delivery)

Patients can track orders through the OptumRx online portal and coordinate infusion appointments.

Cost-Sharing Considerations

Specialty medications like Evkeeza typically have high cost-sharing requirements:

  • Deductible: May need to be met before coverage begins
  • Coinsurance: Often 20-40% for specialty tiers
  • Out-of-pocket maximum: Provides annual cap on patient costs
Note: Specific cost-sharing varies by plan. Review your Summary of Benefits and Coverage (SBC) for exact amounts.

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Provider)
    • Genetic test results or clinical HoFH evidence
    • Complete treatment history with dates and outcomes
    • Current LDL-C levels
    • Timeline: 1-2 days
  2. Submit Prior Authorization (Provider)
  3. Await Initial Decision (UnitedHealthcare)
    • Standard review: 15 business days
    • Urgent review: 72 hours
    • Timeline: As noted above
  4. Coordinate Specialty Pharmacy (Provider/Patient)
    • If approved, OptumRx contacts provider
    • Schedule infusion appointment
    • Timeline: 3-5 business days

Clinician Corner: Medical Necessity Letter Checklist

When submitting prior authorization, include a comprehensive medical necessity letter addressing:

  • Problem Statement: HoFH diagnosis with specific genetic findings or clinical criteria
  • Prior Treatments: Detailed history of statin therapy, ezetimibe use, PCSK9 inhibitor trials
  • Treatment Failures: Specific reasons for inadequate response or intolerance
  • Clinical Rationale: Why Evkeeza is medically necessary based on ANGPTL3 mechanism
  • Monitoring Plan: LDL-C monitoring schedule and safety assessments
  • Guideline Support: Reference to FDA labeling and lipid society recommendations

Appeals Playbook for Florida

If your initial prior authorization is denied, Florida law provides multiple appeal levels:

Internal Appeals (UnitedHealthcare)

Timeline: 180 days from denial notice to file Process: Submit through UnitedHealthcare Provider Portal Decision Time: 30 days (standard), 72 hours (urgent) Required: Appeal form, additional clinical documentation, peer-to-peer review option

External Review (Florida)

When Available: After exhausting internal appeals or if UnitedHealthcare fails to follow proper procedures Timeline: 4 months after final internal denial Process: Request through Florida Department of Financial Services Cost: Free to consumers Decision: Binding on UnitedHealthcare if overturned

Tip: For urgent cases, you can request expedited internal and external review simultaneously.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Incomplete HoFH documentation Submit genetic testing or complete clinical criteria Genetic report or LDL-C >400 mg/dL plus clinical features
Missing background therapy Document statin/ezetimibe use or contraindications Treatment records, allergy documentation
No PCSK9 inhibitor trial Show previous use, failure, or contraindication Medical records, prior authorization history
Quantity limits exceeded Justify weight-based dosing at 15 mg/kg Height, weight, dosing calculations
Not medically necessary Provide comprehensive clinical rationale Detailed medical necessity letter

Patient Support & Cost Assistance

Several programs can help reduce out-of-pocket costs:

EVKEEZA Support Program: Eligible patients with commercial insurance may qualify for copay assistance up to $25,000 annually. Contact 1-877-EVKEEZA (1-877-385-3392) for enrollment.

Foundation Grants: Organizations like the National Organization for Rare Disorders (NORD) offer patient assistance for rare disease treatments.

State Programs: Florida residents may qualify for additional assistance through state pharmaceutical programs.

When navigating complex insurance approvals for expensive specialty medications like Evkeeza, many patients and providers turn to specialized services for help. Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules, incorporating the right medical evidence and required clinical facts.

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in Florida? A: Standard review takes up to 15 business days. Urgent cases are decided within 72 hours. Submit complete documentation to avoid delays.

Q: What if Evkeeza is non-formulary on my plan? A: You can request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. This requires additional documentation but is possible.

Q: Can I request an expedited appeal? A: Yes, if your condition is urgent or could seriously jeopardize your health. Both internal and external expedited reviews are available in Florida.

Q: Does step therapy apply if I failed treatments outside Florida? A: Treatment history from other states is generally accepted. Provide complete medical records documenting previous therapies and outcomes.

Q: What happens if UnitedHealthcare doesn't respond within required timeframes? A: You can file a complaint with Florida's Department of Financial Services and may be eligible for expedited external review.

Q: Can I appeal while continuing current treatment? A: If you're already on Evkeeza, UnitedHealthcare may continue coverage during the appeal process. Confirm this with your plan.

Q: Who can help if I'm overwhelmed by the appeal process? A: Consider working with Counterforce Health or similar services that specialize in insurance appeals, contact Florida's Insurance Consumer Helpline at 1-877-MY-FL-CFO, or seek assistance from patient advocacy organizations.

Q: Are there alternatives if Evkeeza is ultimately denied? A: Other HoFH treatments include PCSK9 inhibitors, lomitapide (Juxtapid), or LDL apheresis. Discuss options with your lipid specialist.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance issues in Florida, contact the state Insurance Consumer Helpline at 1-877-MY-FL-CFO.

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