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

Cigna's Coverage Criteria for Evkeeza (evinacumab-dgnb) in Florida: What Counts as "Medically Necessary"?

Quick Answer: To get Evkeeza (evinacumab-dgnb) covered by Cigna in Florida, you need: (1) confirmed HoFH diagnosis with genetic testing or clinical criteria, (2) documented failure of PCSK9 inhibitor therapy for 8+ weeks with LDL-C ≥70 mg/dL, and (3) prescription from a lipid specialist. Start by gathering your genetic test results, recent lipid panels, and prior therapy records. Submit via Cigna's provider portal with complete clinical documentation. Appeals must be filed within 180 days if denied.

Table of Contents

Policy Overview

Cigna manages Evkeeza (evinacumab-dgnb) as a specialty drug requiring prior authorization across all plan types in Florida—HMO, PPO, and Medicare Advantage. The drug is processed through Express Scripts/Accredo specialty pharmacy and follows Cigna's medical necessity criteria for homozygous familial hypercholesterolemia (HoFH) treatment.

Where to Find Official Documents:

Medical Necessity Requirements

FDA-Approved Indication

Evkeeza is FDA-approved as an adjunct to other LDL-C lowering therapies for the treatment of HoFH in adults and pediatric patients 5 years and older. Off-label use is not covered by Cigna.

Core Eligibility Criteria

All of the following must be documented:

Requirement Specific Details Documentation Needed
Age ≥5 years old Date of birth verification
Diagnosis Confirmed HoFH Genetic testing OR clinical criteria
Prescriber Lipid specialist, cardiologist, or endocrinologist Provider credentials
Prior Therapy PCSK9 inhibitor trial ≥8 weeks with LDL-C ≥70 mg/dL Pharmacy records, lab results
Background Therapy Maximally tolerated statin + ezetimibe (unless contraindicated) Current medication list

HoFH Confirmation Methods

Option 1: Genetic Testing (Preferred)

Option 2: Clinical Criteria

  • Untreated LDL-C >500 mg/dL OR
  • Treated LDL-C ≥300 mg/dL despite maximum therapy
  • Family history consistent with HoFH

Step Therapy & Exceptions

Required Prior Therapies

Before Evkeeza approval, patients must have documented trials of:

  1. Maximally tolerated statin therapy (atorvastatin 80mg, rosuvastatin 40mg, or equivalent)
  2. Ezetimibe 10mg daily (unless contraindicated)
  3. PCSK9 inhibitor (evolocumab or alirocumab) for minimum 8 continuous weeks

Medical Exception Pathways

Florida law (Statute 627.42393) requires Cigna to grant step therapy exceptions when:

  • Previous therapy was ineffective (LDL-C remained ≥70 mg/dL)
  • Patient experienced adverse reactions or contraindications
  • Patient is stable on current Evkeeza therapy (for renewals)
  • Step therapy would harm the patient's condition

Documenting Intolerance/Contraindication

Required documentation includes:

  • Specific adverse events experienced
  • Dates of therapy trials and discontinuation
  • Clinical notes describing intolerance symptoms
  • Alternative therapies considered and rejected

Required Diagnostics

Laboratory Requirements

Test Timing Acceptable Values Notes
Lipid Panel Within 90 days LDL-C ≥70 mg/dL on maximum therapy Fasting preferred
Genetic Testing Any time Two pathogenic HoFH mutations Alternative to clinical criteria
Liver Function Within 6 months Normal ALT/AST Safety monitoring
CK (if indicated) Within 6 months Normal or stable elevation Statin-related monitoring

Documentation Tips

  • Submit complete lab reports with reference ranges
  • Include trending LDL-C values over 3-6 months
  • Highlight failure to reach goal despite maximum therapy
  • Attach genetic counselor reports if available

Site of Care Requirements

Approved Administration Settings

Evkeeza must be administered by healthcare professionals at:

  • Hospital outpatient departments
  • Accredited infusion centers (in-network preferred)
  • Qualified home infusion providers (with prior approval)

Specialty Pharmacy Routing

  • All Evkeeza prescriptions route through Accredo (Cigna's specialty pharmacy)
  • Prescriptions cannot be filled at retail pharmacies
  • Contact Accredo for patient enrollment and scheduling

Florida-Specific Requirements

  • Infusion sites must be Cigna network providers
  • Prior authorization includes site of care approval
  • Out-of-network administration requires separate authorization

Evidence to Support Necessity

Key Clinical Guidelines

Primary Sources to Reference:

Peer-Reviewed Evidence

  • ELIPSE HoFH trial data showing 49% LDL-C reduction
  • Real-world effectiveness studies in HoFH populations
  • Safety data from clinical trials and post-marketing surveillance

How to Cite Effectively

Tip: Include specific page numbers and publication dates when referencing guidelines. Quote directly from FDA labeling for dosing and administration requirements.

Sample Medical Necessity Letter

Template Structure for Providers:

"This [age]-year-old patient has genetically confirmed HoFH with [specific mutations] and severely elevated LDL-C of [value] mg/dL despite maximally tolerated background therapy including [statin] [dose], ezetimibe 10mg daily, and [PCSK9 inhibitor] for [duration]. Prior therapy with [PCSK9 inhibitor] was [ineffective/not tolerated] as evidenced by [specific details].

Based on FDA labeling and current guidelines, Evkeeza is indicated as adjunctive therapy for HoFH when other LDL-lowering therapies are insufficient. The patient meets all clinical criteria and is expected to benefit from this targeted therapy. Alternative treatments [list and explain why unsuitable].

I will monitor the patient with quarterly lipid panels and assess for clinical response. The requested dose of 15 mg/kg IV every 4 weeks follows FDA-approved dosing for HoFH."

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing HoFH confirmation Submit genetic test results or clinical criteria documentation Lab reports, genetic counselor summary
Insufficient prior therapy Document PCSK9 inhibitor trial ≥8 weeks Pharmacy records, clinical notes
Lack of specialist involvement Obtain prescription from qualified specialist Provider credentials, consultation notes
Incomplete lab data Submit recent lipid panel showing LDL-C ≥70 mg/dL Complete lab report within 90 days
Site of care issues Verify in-network infusion center Facility network status confirmation

Appeals Process in Florida

Internal Appeals Timeline

  • Level 1: File within 180 days of denial; decision in 72 hours (24 hours if urgent)
  • Level 2: Automatic review if Level 1 denied; same timeline
  • Peer-to-peer review: Request direct physician discussion with Cigna medical director

External Review Process

After exhausting internal appeals, Florida residents can request external review:

Required Appeal Documentation

  • Original denial letter with specific reasons
  • Complete medical records and specialist letters
  • Evidence of prior therapy failures or contraindications
  • Current disease status and treatment goals
  • Reference to Florida Statute 627.42393 for step therapy protections
From our advocates: We've seen Florida patients successfully overturn Cigna denials by submitting comprehensive genetic testing results alongside detailed specialist letters explaining why PCSK9 inhibitors were insufficient. The key is demonstrating that all standard therapies were tried and failed before requesting Evkeeza.

FAQ

How long does Cigna prior authorization take in Florida? Standard decisions are made within 72 hours; urgent cases within 24 hours. Complex cases may take up to 14 days with additional documentation requests.

What if Evkeeza is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Florida law supports coverage for medically necessary non-formulary drugs.

Can I request an expedited appeal? Yes, if delay would jeopardize your health or interrupt current therapy. Submit expedited appeal request with clinical justification for urgency.

Does step therapy apply if I failed therapies in another state? Yes, documented prior therapy failures from any location count toward meeting step therapy requirements. Include complete pharmacy and medical records.

What if my doctor isn't a specialist? Cigna requires prescription by or consultation with a lipid specialist, cardiologist, or endocrinologist. Your primary care doctor can refer you or co-manage with a specialist.

How much will Evkeeza cost with Cigna coverage? Costs vary by plan. Check your specialty drug copay/coinsurance. Regeneron's patient assistance program may help with out-of-pocket costs.

Understanding your insurance coverage doesn't have to be overwhelming. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical documentation to create targeted, evidence-backed responses. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes, ensuring you get the coverage you need for life-changing treatments like Evkeeza.

The key to Cigna approval in Florida is thorough preparation and understanding exactly what documentation satisfies their medical necessity criteria. With genetic confirmation of HoFH, documented prior therapy failures, and specialist involvement, most patients can successfully obtain coverage. If you face a denial, Florida's robust appeal rights and external review process provide additional pathways to coverage.

When dealing with Counterforce Health's guidance and Florida's patient protection laws, you have strong tools to advocate for medically necessary treatments. Don't let initial denials discourage you—persistence and proper documentation often lead to approval.

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 company for specific coverage decisions. Insurance policies and requirements may change. For personalized assistance with insurance appeals in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO.

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