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

How to Get Evkeeza (Evinacumab-dgnb) Covered by Humana in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Evkeeza Covered by Humana in New York

Evkeeza (evinacumab-dgnb) is covered by Humana Medicare Advantage plans but requires prior authorization. For fastest approval: (1) Your provider submits genetic testing results confirming homozygous familial hypercholesterolemia (HoFH), documented LDL-C levels >400-500 mg/dL, and records of maximally tolerated lipid-lowering therapy failures, (2) Request expedited review if clinically urgent, and (3) If denied, file internal appeal within 65 days, then external review through New York DFS within 4 months. New York's external review has strong patient protections with 72-hour expedited decisions for urgent drug denials.

Table of Contents

Plan Types & Coverage Implications

Humana offers several Medicare plan types in New York, each with different implications for Evkeeza coverage:

Medicare Advantage (Part C) plans include both medical and prescription drug benefits. These plans typically have the most comprehensive prior authorization requirements for specialty biologics like Evkeeza. Network restrictions apply, meaning you'll need to use Humana's preferred specialty pharmacy partners.

Medicare Part D standalone prescription drug plans cover Evkeeza under the pharmacy benefit, while infusion administration may fall under Part B if given in a clinical setting. Verify your specific plan's coverage through Humana's drug list tool.

Note: New York has over 95% insurance coverage, with strong consumer protections. If you're switching from another insurer, Humana provides a 90-day transition period for existing specialty medications.

Formulary Status & Tier Placement

Evkeeza is included in Humana's 2024 Medicare formulary but requires prior authorization and may have additional restrictions. The medication is typically placed on a high specialty tier, which affects your cost-sharing responsibilities.

Coverage Element Status Details
Formulary Status Covered Listed in 2024 Humana Medicare drug lists
Prior Authorization Required Must be approved before coverage
Step Therapy Possible May require trying other lipid-lowering therapies first
Quantity Limits Possible Based on FDA-approved dosing (15 mg/kg every 4 weeks)

The drug's tier placement determines your copayment or coinsurance. Specialty biologics like Evkeeza are typically placed on Tier 5 (specialty tier), which may require 25-33% coinsurance after meeting your deductible.

Prior Authorization Requirements

Genetic Testing Documentation Humana requires prior authorization for HoFH genetic testing, which is often necessary to support Evkeeza coverage. Submit genetic testing requests with:

  • Clinical diagnosis showing severely elevated LDL cholesterol (typically >400-500 mg/dL)
  • Family history of premature cardiovascular disease
  • Previous lipid-lowering therapy records showing inadequate response
  • Medical records supporting suspicion of HoFH

Medical Necessity Criteria For Evkeeza approval, documentation must demonstrate:

  1. Confirmed HoFH diagnosis through genetic testing or clinical criteria
  2. Age requirement met (FDA-approved for patients ≥5 years)
  3. Maximally tolerated lipid-lowering therapy has been tried and failed or is contraindicated
  4. Baseline LDL-C levels documented before and after conventional treatments
  5. Treatment goals clearly defined with monitoring plan

Specialty Pharmacy Network

CenterWell Specialty Pharmacy is Humana's owned specialty pharmacy network, providing personalized guidance and clinical support for Evkeeza patients. CenterWell offers:

  • Medication delivery to your preferred location
  • Financial assistance program navigation
  • Clinical support and monitoring
  • Prior authorization assistance
Tip: Using Humana's preferred specialty pharmacy network often results in faster prior authorization processing and better coordination of care.

For infusion administration, verify that your chosen infusion center is in Humana's network. Some patients may need to receive Evkeeza at hospital outpatient departments or specialty infusion centers rather than traditional pharmacies.

Cost-Share Dynamics

Understanding your costs helps you plan for Evkeeza therapy:

Deductible Phase: You may pay the full negotiated price until meeting your plan's deductible (varies by plan, typically $200-500 for Medicare Advantage).

Coverage Phase: After meeting the deductible, you'll pay your tier's copayment or coinsurance. For specialty biologics, this is often 25-33% of the drug cost.

Catastrophic Coverage: Once you reach the annual out-of-pocket maximum, you'll pay minimal amounts (typically $4.50-$11.20 per prescription in 2024).

Financial Assistance: Regeneron offers patient assistance programs. Contact their support team to explore copay cards or foundation grants that may reduce your out-of-pocket costs.

Submission Process

Provider Submission Requirements: Submit prior authorization requests through:

  • Electronic portal: Humana's provider portal (preferred method)
  • Fax: 1-877-486-2621 for clinical pharmacy review
  • Phone: 800-555-CLIN (2546) for clinical pharmacy review

Required Documentation:

  • Complete prior authorization form
  • Medical records supporting HoFH diagnosis
  • Genetic testing results (if available)
  • Laboratory values (lipid panels over time)
  • Documentation of prior therapy failures
  • Treatment plan with monitoring schedule

Timeline Expectations:

  • Standard review: 30 days for pre-service decisions
  • Expedited review: 72 hours for urgent requests
  • Most complete electronic requests receive response within one business day

Common Approval Patterns

Successful Evkeeza prior authorizations typically include:

Strong Clinical Documentation:

  • Genetic confirmation of HoFH (homozygous mutations in LDLR, APOB, PCSK9, or LDLRAP1)
  • LDL-C levels >400 mg/dL despite maximal statin therapy
  • Documentation of cardiovascular risk factors
  • Clear treatment goals and monitoring plan

Prior Therapy Documentation:

  • Maximally tolerated statin therapy
  • Ezetimibe trial (if tolerated)
  • PCSK9 inhibitor trial (evolocumab or alirocumab)
  • Reasons for discontinuation or inadequate response

Prescriber Expertise:

  • Requests from lipidologists or endocrinologists often have higher approval rates
  • Involvement of specialized HoFH treatment centers

Appeals Process for New York

If your initial prior authorization is denied, New York provides robust appeal rights:

Internal Appeals (First Step):

  • Deadline: File within 65 days of denial
  • Timeline: 30 days for pre-service appeals, 7 days for Part D drug appeals
  • Expedited: 72 hours for urgent medical situations
  • Submission: Use Humana's appeal form via online portal, fax, or mail

External Review (Second Step): New York's external appeal process through the Department of Financial Services (DFS) provides independent medical review:

  • Deadline: 4 months after final internal denial
  • Timeline: 72 hours for urgent cases, 30 days for standard review
  • Cost: $25 fee (waived for Medicaid or financial hardship)
  • Decision: Binding on Humana if overturned

Getting Help:

  • Community Health Advocates: 888-614-5400 (free appeals assistance)
  • New York SHIP: Free Medicare counseling and appeals support
From our advocates: We've seen HoFH cases successfully overturned on external review when genetic testing was initially deemed "not medically necessary." The key was submitting peer-reviewed literature showing genetic confirmation improves treatment selection and family screening. While outcomes vary, comprehensive documentation significantly improves approval chances.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Medical Necessity Letters:

  1. Patient Demographics & Diagnosis
    • Age, weight (for dosing calculation)
    • ICD-10: E78.01 (Familial hypercholesterolemia)
    • Genetic testing results confirming HoFH
  2. Clinical History
    • Baseline and current LDL-C levels
    • Cardiovascular risk assessment
    • Family history of premature CAD
  3. Prior Treatment Documentation
    • Maximum tolerated statin dose and duration
    • Ezetimibe trial (dose, duration, response)
    • PCSK9 inhibitor trial (if applicable)
    • Reasons for discontinuation or inadequate response
  4. Treatment Plan
    • Evkeeza dosing: 15 mg/kg IV every 4 weeks
    • Monitoring schedule (lipid panels, safety labs)
    • Treatment goals (target LDL-C reduction)

Supporting Literature:

  • FDA prescribing information for Evkeeza
  • AHA/ACC guidelines on cholesterol management
  • Specialty society recommendations for HoFH treatment

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"HoFH not documented" Submit genetic testing results or clinical criteria documentation (LDL-C >500 mg/dL + family history)
"Prior therapies not tried" Document maximum tolerated doses and durations of statins, ezetimibe, and PCSK9 inhibitors
"Not FDA-approved indication" Emphasize FDA approval for HoFH in patients ≥5 years; include prescribing information
"Experimental/investigational" Reference FDA approval date (February 2021) and established clinical guidelines
"Site of care issues" Clarify whether requesting Part B (infusion center) or Part D (specialty pharmacy) coverage

Frequently Asked Questions

How long does Humana prior authorization take for Evkeeza in New York? Standard review takes up to 30 days, but most complete electronic submissions receive responses within one business day. Expedited reviews are completed within 72 hours for urgent medical situations.

What if Evkeeza is denied as "not medically necessary"? File an internal appeal within 65 days with additional clinical documentation. If denied again, New York's external review process provides independent medical evaluation with decisions binding on Humana.

Does step therapy apply to Evkeeza? Humana may require documentation that conventional lipid-lowering therapies (statins, ezetimibe, PCSK9 inhibitors) have been tried and failed or are contraindicated before approving Evkeeza.

Can I get expedited approval for Evkeeza? Yes, if your clinical situation is urgent and delay would seriously jeopardize your health. Your provider must document the medical urgency in the expedited review request.

What documentation do I need for genetic testing coverage? Clinical records showing severely elevated cholesterol despite treatment, family history of premature cardiovascular disease, and medical necessity for genetic confirmation of HoFH diagnosis.

How much will Evkeeza cost with Humana coverage? Costs depend on your plan's specialty tier coinsurance (typically 25-33%) and whether you've met your deductible. The manufacturer offers patient assistance programs that may reduce out-of-pocket costs.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements. For complex cases like HoFH treatments, we help identify the right clinical evidence and craft compelling medical necessity arguments.

Getting Evkeeza covered requires careful documentation and persistence, but New York's strong consumer protections provide multiple pathways to approval. Whether you're navigating initial prior authorization or appealing a denial, Counterforce Health can help streamline the process with payer-specific strategies and evidence-based appeals.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan, medical condition, and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official appeals assistance in New York, contact Community Health Advocates at 888-614-5400.

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