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

How to Get Evkeeza (Evinacumab) Covered by Humana in Florida: Appeals, Forms & Timeline Guide

Quick Answer: Getting Evkeeza Covered by Humana in Florida

Evkeeza (evinacumab) requires prior authorization from Humana Medicare Advantage plans in Florida. Submit clinical documentation confirming homozygous familial hypercholesterolemia (HoFH) diagnosis, prior therapy failures, and current lipid levels. If denied, you have 65 days to appeal with additional evidence. For urgent cases, request expedited review within 24-72 hours.

First step today: Contact your prescriber to gather HoFH diagnostic documentation (genetic testing, lipid panels, family history) and submit the prior authorization request through Humana's provider portal or fax 888-447-3430.

Table of Contents

  1. Understanding Your Denial Letter
  2. Prior Authorization Requirements
  3. Medical Necessity Documentation
  4. First-Level Appeal Process
  5. Peer-to-Peer Review Strategy
  6. External Review in Florida
  7. Appeal Letter Templates
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Programs
  10. When to Escalate

Understanding Your Denial Letter

When Humana denies Evkeeza coverage, your denial letter will specify the reason and your appeal rights. Common denial codes include:

  • Prior authorization required - Submit clinical documentation before dispensing
  • Step therapy not met - Must try preferred alternatives first unless contraindicated
  • Medical necessity not established - Need stronger clinical justification for HoFH diagnosis
  • Non-formulary drug - Evkeeza may require formulary exception
Important: You have 65 days from the denial date to file an appeal with Humana Medicare Advantage plans in Florida.

Prior Authorization Requirements

Evkeeza requires prior authorization for all Humana Medicare Advantage members in Florida. Here's what you need:

Required Documentation

Requirement Details Where to Submit
HoFH Diagnosis Genetic testing results, LDL-C >400 mg/dL untreated Provider portal
Prior Therapies Documentation of statin, PCSK9 inhibitor, ezetimibe trials Fax: 888-447-3430
Current Labs Recent lipid panel showing inadequate control Phone: 866-461-7273
Prescriber Info NPI, TIN, and clinical rationale Electronic: CoverMyMeds

Submission Process

  1. Gather documentation - HoFH diagnosis, treatment history, current labs
  2. Submit via preferred method - Online portal processes fastest (typically 7 days)
  3. Include all required fields - Member ID, DOB, J-code J1305, diagnosis E78.01
  4. Track your request - Use Humana's prior authorization search tool

Medical Necessity Documentation

Clinician Corner: HoFH Diagnostic Criteria

Your medical necessity letter must demonstrate Evkeeza meets established HoFH treatment guidelines:

Required Clinical Evidence:

  • LDL-C levels: Untreated >400 mg/dL or >300 mg/dL on maximally tolerated therapy
  • Genetic confirmation: Two pathogenic variants in LDLR, APOB, or PCSK9 genes
  • Physical findings: Tendon/cutaneous xanthomas before age 10 (if present)
  • Family history: Both parents with heterozygous FH or premature ASCVD

Prior Therapy Documentation:

  • Statin therapy at maximally tolerated dose with outcomes
  • PCSK9 inhibitor trial (evolocumab/alirocumab) if appropriate
  • Ezetimibe therapy and response
  • LDL apheresis consideration or contraindications
Tip: Reference the 2023 EAS Consensus Statement on HoFH for the most current diagnostic criteria when writing your appeal.

First-Level Appeal Process

Timeline and Submission

  • Deadline: 65 days from denial notice
  • Decision timeframe: 30 days for standard appeals, 72 hours for expedited
  • Submit to: Humana Medicare Appeals Department

Appeal Letter Structure

  1. Header: Member information, denial date, requested medication
  2. Clinical summary: HoFH diagnosis with supporting evidence
  3. Prior therapy failures: Specific drugs tried, doses, duration, outcomes
  4. Medical necessity: Why Evkeeza is essential for this patient
  5. Supporting attachments: Labs, genetic testing, specialist notes

Peer-to-Peer Review Strategy

If your initial prior authorization is denied, request a peer-to-peer review with a Humana medical director.

How to Schedule

  • Contact: Request through denial notification instructions
  • Participants: Prescribing physician and Humana medical director only
  • Preparation time: Usually 24-48 hours notice provided
  • Duration: Typically 10-15 minutes

Key Talking Points

  1. Patient-specific factors: Why formulary alternatives failed or are contraindicated
  2. HoFH severity: Genetic findings and cardiovascular risk
  3. Treatment urgency: Consequences of delayed therapy
  4. Monitoring plan: How you'll track safety and efficacy
From our advocates: In peer-to-peer calls for rare disease therapies like Evkeeza, medical directors respond well to specific genetic data and clear documentation of prior therapy failures. Having lab values and genetic test results readily available during the call significantly improves approval rates.

External Review in Florida

If Humana upholds their denial after internal appeals, you can request an independent external review through the Florida Department of Financial Services.

External Review Process

Step Timeline Action Required
Internal appeal exhausted - Final denial from Humana
File external review Within 4 months Submit to Florida DFS
Independent review 45 days standard, 72 hours expedited Medical expert evaluation
Final decision - Binding on Humana if favorable

How to File

  • Contact: Florida DFS Consumer Helpline at 1-800-FL-HEALTH (1-800-354-3258)
  • Forms: Available through DFS Medical Provider Portal
  • Required documents: Final denial letter, clinical records, specialist support
  • Cost: No charge to consumer

Appeal Letter Templates

Medical Necessity Letter Template

Subject: Prior Authorization Appeal - Evkeeza (evinacumab) for [Patient Name]

Dear Humana Medical Review Team,

I am writing to appeal the denial of coverage for Evkeeza (evinacumab) for my patient [Name], DOB [Date], Humana ID [Number].

DIAGNOSIS: Homozygous Familial Hypercholesterolemia (ICD-10: E78.01)

CLINICAL EVIDENCE:
- Genetic testing confirms [specific mutations in LDLR/APOB/PCSK9]
- Untreated LDL-C: [value] mg/dL
- Current LDL-C on maximally tolerated therapy: [value] mg/dL

PRIOR THERAPIES TRIED:
- Atorvastatin 80mg daily x [duration] - LDL-C reduced to [value]
- Evolocumab 140mg Q2W x [duration] - Additional reduction to [value]
- Ezetimibe 10mg daily - Minimal additional benefit

MEDICAL NECESSITY:
This patient requires Evkeeza because [specific clinical rationale]. Alternative therapies have failed to achieve adequate LDL-C reduction, and the patient remains at extremely high cardiovascular risk.

Attached: Genetic testing results, lipid panels, clinical notes

Sincerely,
[Prescriber name, credentials]

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"HoFH not documented" Submit genetic testing results and family history
"Prior therapies not tried" Provide detailed treatment history with outcomes
"Medical necessity not established" Include specialist consultation and risk assessment
"Experimental/investigational" Reference FDA approval and clinical guidelines
"Step therapy required" Document contraindications or failures of preferred agents

Cost Assistance Programs

While pursuing insurance coverage, explore these financial assistance options:

Manufacturer Support

  • Regeneron Patient Assistance: Income-based free drug program
  • Commercial copay assistance: Up to $15,000 annually for eligible patients
  • Eligibility: Verify through Regeneron's patient support (verify current programs)

Additional Resources

  • National Organization for Rare Disorders (NORD): Emergency financial assistance
  • HealthWell Foundation: Copay assistance for rare disease medications
  • Patient Access Network (PAN): Disease-specific financial support

When to Escalate

File a Complaint with Florida Regulators

If Humana fails to follow proper appeal procedures or unreasonably delays decisions:

  • Florida Department of Financial Services: Consumer complaint portal
  • Phone: 1-877-MY-FL-CFO (1-877-693-5236)
  • Required information: Policy number, denial letters, appeal correspondence

Federal Oversight

For Medicare Advantage plans:

  • Medicare.gov complaints: Report coverage denials and appeal issues
  • 1-800-MEDICARE: Phone support for beneficiary rights

Tracking Your Appeal

Document everything throughout the process:

  • Submission dates: When you filed PA requests and appeals
  • Reference numbers: Track all correspondence with confirmation numbers
  • Response deadlines: Note when Humana must respond by law
  • Contact logs: Record all phone calls with representatives

About Counterforce Health: Counterforce Health helps patients and clinicians navigate insurance denials by creating targeted, evidence-backed appeals. Our platform analyzes denial letters and drafts point-by-point rebuttals aligned with payer policies, pulling the right clinical evidence and citations to strengthen your case.

Frequently Asked Questions

How long does Humana prior authorization take for Evkeeza in Florida? Standard prior authorization decisions are made within 7 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Evkeeza is not on Humana's formulary? You can request a formulary exception by submitting clinical documentation showing medical necessity and why formulary alternatives are inadequate.

Can I request an expedited appeal if my condition is urgent? Yes, if delay could seriously jeopardize your health, request expedited review. Decisions are typically made within 72 hours.

Does step therapy apply if I've tried other therapies outside of Florida? Yes, document all prior therapies regardless of where they were prescribed. Include medical records showing outcomes and reasons for discontinuation.

What happens if my external review is denied? External review decisions are final and binding. However, you may have options to resubmit with additional evidence or explore alternative coverage pathways.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance representative for guidance specific to your situation. Coverage policies and appeal procedures may change - verify current requirements with Counterforce Health or your insurer directly.

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