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

Work With Your Doctor to Get Evkeeza (evinacumab-dgnb) Approved by Aetna (CVS Health) in Florida: Medical Necessity Letters, Appeals, and Provider Scripts

Answer Box: How to Get Evkeeza Covered by Aetna (CVS Health) in Florida

Getting Evkeeza (evinacumab-dgnb) approved by Aetna (CVS Health) in Florida requires prior authorization with documented homozygous familial hypercholesterolemia (HoFH) and failure of maximally tolerated statin, ezetimibe, and PCSK9 inhibitor therapy. First step: Schedule an appointment with your prescribing specialist to gather genetic testing results, lipid panels, and treatment history. Your doctor must complete Aetna's Evkeeza Precertification Request form and submit via phone (866-752-7021) or fax (888-267-3277). If denied, you have 180 days for internal appeals and expedited review options for urgent cases.

Table of Contents

  1. Set Your Goal: Understanding Aetna's Requirements
  2. Visit Prep: Documenting Your Medical Journey
  3. Evidence Kit: Essential Documents and Testing
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Review Support
  6. After-Visit Documentation
  7. Respectful Persistence and Appeals
  8. FAQ: Common Questions

Set Your Goal: Understanding Aetna's Requirements

Before your appointment, understand what Aetna (CVS Health) requires for Evkeeza approval. According to Aetna's clinical policy, you'll need:

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed
HoFH diagnosis Confirmed homozygous familial hypercholesterolemia Genetic testing or clinical criteria
Age requirement Patient ≥5 years old Birth date verification
Background therapy Maximally tolerated lipid-lowering drugs Treatment history with doses/dates
LDL-C levels Baseline and current cholesterol levels Laboratory reports
Prior authorization Formal approval before coverage Completed precertification form

Your partnership with your doctor is crucial because Aetna requires physician attestation on their specialized form. You can't navigate this alone—but you can come prepared to make the process efficient.

Tip: Download and review Aetna's Evkeeza precertification form before your visit so you understand what information your doctor will need.

Visit Prep: Documenting Your Medical Journey

Come to your appointment with a comprehensive timeline of your condition and treatments. This preparation saves time and ensures nothing important gets missed.

Symptom and Diagnosis Timeline

Create a written timeline including:

  • First cholesterol screening and results
  • Family history of heart disease or high cholesterol
  • Physical signs like xanthomas (cholesterol deposits) or corneal arcus
  • Cardiovascular events (heart attacks, procedures, hospitalizations)
  • Genetic testing dates and results

Treatment History Documentation

For each lipid-lowering medication you've tried, note:

  • Drug name and dose (e.g., "atorvastatin 80mg daily")
  • Start and stop dates
  • Reason for discontinuation (side effects, inadequate response, contraindication)
  • LDL-C levels before and during treatment
  • Side effects experienced with specific details

According to Aetna's requirements, you must have tried or be unable to tolerate maximally tolerated statin therapy plus ezetimibe, and typically a PCSK9 inhibitor as well.

Functional Impact Notes

Document how HoFH affects your daily life:

  • Physical limitations from cardiovascular disease
  • Quality of life impacts
  • Work or activity restrictions
  • Anxiety about future cardiac events

This information helps your doctor articulate medical necessity in the approval request.

Evidence Kit: Essential Documents and Testing

Gather these documents before your appointment to streamline the approval process:

Laboratory Results

  • Genetic testing report showing pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Baseline LDL-C (before any treatment)
  • Serial lipid panels showing response to various treatments
  • Most recent lipid panel (within 30 days)

Medical Records

  • Cardiology consultation notes
  • Imaging reports (coronary calcium scores, echocardiograms, stress tests)
  • Procedure reports (catheterizations, angioplasty, bypass surgery)
  • Family history documentation

Treatment Documentation

  • Pharmacy records showing filled prescriptions and dates
  • Prior authorization forms for previous medications
  • Insurance denial letters for other treatments
  • Apheresis records if you've received LDL apheresis

Counterforce Health specializes in helping patients and providers compile exactly this type of evidence-backed documentation for insurance appeals. Their platform can help identify gaps in your medical record that might lead to denials and ensure your submission meets Aetna's specific requirements.

Medical Necessity Letter Structure

Your doctor's medical necessity letter is often the deciding factor in approval. Here's what should be included based on successful appeals:

Essential Letter Components

Patient Identification and Diagnosis

  • Full name, date of birth, member ID
  • Primary diagnosis: Homozygous familial hypercholesterolemia (ICD-10: E78.01)
  • Diagnostic confirmation method (genetic testing or clinical criteria)

Clinical Rationale

  • Current LDL-C level and cardiovascular risk
  • Prior treatment failures with specific drugs, doses, and durations
  • Why Evkeeza is medically necessary for this specific patient
  • Expected outcomes and monitoring plan

Supporting Evidence

  • FDA approval for HoFH in patients ≥5 years
  • Relevant clinical guidelines (AHA/ACC, EAS consensus)
  • Published literature on Evkeeza efficacy in HoFH

Key Phrases That Work

Your doctor should use specific language that aligns with Aetna's criteria:

  • "Despite maximally tolerated statin therapy combined with ezetimibe..."
  • "Patient has documented homozygous familial hypercholesterolemia confirmed by genetic testing showing..."
  • "LDL-C remains severely elevated at [X] mg/dL, placing patient at extremely high risk for cardiovascular events..."
  • "Evkeeza's ANGPTL3 inhibition provides LDL-C lowering independent of LDL receptor function..."

Peer-to-Peer Review Support

If your initial request is denied, Aetna offers peer-to-peer review where your doctor can speak directly with an Aetna medical director.

Preparing Your Doctor for P2P

Schedule Coordination

  • Offer flexible appointment times for the call
  • Provide your doctor with 2-3 preferred time windows
  • Understand that P2P calls typically last 15-30 minutes

Case Summary Preparation Help your doctor prepare a concise summary:

  1. Patient age and HoFH confirmation method
  2. Current LDL-C and cardiovascular risk factors
  3. Complete prior treatment history with outcomes
  4. Specific rationale for Evkeeza over alternatives
  5. Clinical urgency factors

Supporting Your Provider

  • Be available during business hours in case additional information is needed
  • Provide contact information where you can be reached quickly
  • Offer to obtain additional records or test results if requested
Note: According to Aetna's provider policies, peer-to-peer reviews for urgent requests are typically resolved within 36-72 hours.

After-Visit Documentation

After your appointment, ensure proper documentation and submission:

What to Save

  • Copy of the completed Aetna Evkeeza precertification form
  • Medical necessity letter draft or final version
  • Submission confirmation (fax confirmation, portal screenshot, phone reference number)
  • Timeline of when to expect a decision

Portal Communication

Use your patient portal to:

  • Request copies of all submitted documents
  • Ask for updates on the approval status
  • Clarify next steps if additional information is needed

Follow-Up Schedule

Establish a follow-up plan with your provider's office:

  • Check status in 5-7 business days if no response
  • Escalate to appeals if denied
  • Schedule infusion once approved

Respectful Persistence and Appeals

If your initial request is denied, Florida residents have specific appeal rights with Aetna.

Internal Appeals Process

According to Aetna Better Health of Florida policies, you have:

Standard Appeal Timeline

  • File within: 60 days of denial notice
  • Decision timeframe: 30 days for standard appeals
  • Expedited option: 72 hours for urgent medical needs

Required Documentation

  • Original denial letter
  • Additional medical records supporting necessity
  • Updated clinical information
  • Specialist recommendations

External Review Options

If internal appeals are unsuccessful, Florida residents can pursue:

Aetna External Review Program

State-Level Appeals

Escalation Strategy

Week 1-2: Initial submission and follow-up Week 3-4: Peer-to-peer review if denied Week 5-8: Internal appeal with additional documentation Week 9+: External review or state-level complaint

From our advocates: One patient's approval was initially denied for "insufficient documentation of treatment failures." Working with their cardiologist, they compiled a detailed treatment timeline with specific LDL-C values and side effects for each medication tried. The appeal was approved within two weeks, emphasizing how thorough documentation can make the difference.

FAQ: Common Questions

How long does Aetna (CVS Health) prior authorization take in Florida? Standard decisions typically take 30-45 days. Expedited appeals for urgent medical needs are resolved within 72 hours.

What if Evkeeza is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. Use the same precertification process with additional emphasis on lack of formulary alternatives.

Can I request an expedited appeal? Yes, if waiting for standard review could seriously jeopardize your health. Your doctor must certify medical urgency in the appeal request.

Does step therapy apply if I failed treatments outside Florida? Treatment history from any location counts. Provide documentation of prior failures regardless of where treatment occurred.

What happens if I'm already receiving Evkeeza and coverage is denied? File an appeal immediately and ask about "aid continuing" options that may allow treatment to continue during the appeal process.

How much does Evkeeza cost without insurance? The average wholesale acquisition cost is approximately $450,000 per year. Manufacturer assistance programs may be available through Regeneron's patient support.

Can I appeal to the state if Aetna denies my request? Yes, Florida residents can file complaints with the Office of Insurance Regulation for commercial plans or request fair hearings for Medicaid plans.

What specialist should prescribe Evkeeza? Typically cardiologists, lipidologists, or endocrinologists with expertise in familial hypercholesterolemia. Aetna may require specialist prescribing for approval.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance approvals by turning denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to identify specific approval criteria and draft point-by-point rebuttals that align with each insurer's requirements. For patients facing Evkeeza denials, this type of systematic approach to appeals documentation can significantly improve approval rates.

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 plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage questions. For assistance with insurance complaints in Florida, contact the Florida Department of Financial Services at 1-877-MY-FL-CFO.

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