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

How to Get Evkeeza (evinacumab-dgnb) Covered by Humana in Michigan: Prior Authorization Forms, Appeal Timelines & Scripts

Quick Answer: Getting Evkeeza Covered by Humana in Michigan

Evkeeza (evinacumab-dgnb) requires prior authorization from Humana and is covered under your medical benefit, not pharmacy benefit, since it's given by IV infusion. Your fastest path to approval: 1) Confirm HoFH diagnosis with genetic testing or clinical criteria, 2) Document maximally tolerated background therapy (statin, ezetimibe, PCSK9 inhibitor unless contraindicated), and 3) Submit Humana's preauthorization form with recent LDL-C levels. If denied, you have 65 days to appeal and can request expedited review (72-hour decision) for urgent cases. Michigan residents also have external review rights through DIFS within 127 days of final denial.

Table of Contents

What This Guide Covers

This step-by-step guide helps Michigan patients with homozygous familial hypercholesterolemia (HoFH) navigate Humana's prior authorization process for Evkeeza (evinacumab-dgnb). Whether you're newly diagnosed or switching from another treatment, we'll walk you through gathering documentation, submitting your request, and appealing denials if necessary.

Evkeeza is a specialized ANGPTL3 inhibitor given by IV infusion every 4 weeks, typically costing around $450,000 annually. Given this cost and complexity, every major insurer including Humana requires prior authorization. The good news? With proper documentation, approval rates are generally favorable for patients who meet clinical criteria.

From our advocates: We've seen patients get Evkeeza approved on the first try when their clinic includes genetic testing results, documents all prior lipid-lowering therapies with specific start/stop dates and LDL-C responses, and submits a detailed letter explaining why standard treatments haven't achieved target levels. The key is thoroughness upfront rather than rushing the initial submission.

Before You Start: Verify Your Coverage

Confirm Your Plan Type and Benefits

Check if you have Humana Medicare Advantage (most common in Michigan) or commercial Humana coverage. This affects which forms you'll use and your appeal rights. Call the number on your insurance card or log into your Humana member portal to verify.

Medical vs. Pharmacy Benefit

Evkeeza is covered under your medical benefit, not pharmacy benefit, because it requires IV infusion by healthcare professionals. This means:

  • Your doctor's office or infusion center will handle the prior authorization
  • The drug will be billed like other infused medications (chemotherapy, biologics)
  • You won't pick this up at a retail or specialty pharmacy

Network Status

Verify that your planned infusion site (hospital outpatient department, infusion center, or clinic) is in-network with Humana. Out-of-network administration could result in much higher out-of-pocket costs even if the drug itself is covered.

Gather What You Need

Essential Documentation

Diagnosis Confirmation:

  • Genetic testing results showing two pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • OR clinical diagnosis with LDL-C >400 mg/dL plus family history and/or xanthomas
  • ICD-10 code E78.01 (Familial hypercholesterolemia) documented in medical records

Treatment History:

  • Complete record of maximally tolerated statin therapy (drug, dose, duration, LDL-C response, reason for discontinuation if applicable)
  • Ezetimibe trial documentation (dose, duration, LDL-C response)
  • PCSK9 inhibitor trial for at least 8 weeks at maximum dose (evolocumab or alirocumab) with post-treatment LDL-C ≥70 mg/dL
  • Note: Children ages 5-9 may not require PCSK9 inhibitor trial per some policies

Recent Lab Results:

  • Most recent lipid panel showing LDL-C levels
  • Any other relevant cardiovascular risk markers

Forms and Contact Information

Humana Prior Authorization:

  • Download the preauthorization form from Humana's provider portal
  • Submission fax: 502-508-9300
  • Phone: 866-421-5663 (Monday-Friday, 7 AM-7 PM Central)

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Complete Humana's PA Form Your healthcare provider should fill out all required fields, including:

  • Patient demographics and insurance information
  • HoFH diagnosis with ICD-10 code E78.01
  • Detailed treatment history
  • Current LDL-C levels and treatment goals
  • Requested dosing: 15 mg/kg IV every 4 weeks

2. Attach Supporting Documentation

  • Copy of insurance card
  • Genetic testing results or clinical diagnosis documentation
  • Treatment history with specific dates, doses, and outcomes
  • Recent lab results
  • Letter of medical necessity (recommended)

3. Submit Complete Package

  • Fax: 502-508-9300 (verify this number with current Humana materials)
  • Phone: 866-421-5663 for urgent cases
  • Include NDC code on all submissions for proper processing

Medical Necessity Letter Tips

Your doctor's letter should address:

  • Confirmed HoFH diagnosis and severity (genetic or clinical criteria)
  • Failure to achieve LDL-C goals despite maximally tolerated conventional therapy
  • Specific contraindications or intolerances to standard treatments
  • Expected clinical benefit from Evkeeza based on clinical trial data
  • Plan for monitoring and follow-up

Follow-Up and Timeline Expectations

Standard Processing Times

Humana typically processes prior authorizations within:

  • Standard requests: 15 business days for medical benefit drugs
  • Expedited requests: 72 hours when health urgency is documented
  • Complex cases may take up to 30 days

When and How to Follow Up

Call Humana at 866-421-5663 if:

  • No response after 10 business days
  • You need to provide additional information
  • Your doctor recommends expedited review due to urgent medical need

Sample Follow-Up Script: "Hi, I'm calling to check on the status of a prior authorization request for Evkeeza for [patient name], member ID [number]. The request was submitted on [date] via fax. Can you tell me the current status and if any additional information is needed?"

Document everything: Keep records of confirmation numbers, representative names, and any additional requirements mentioned.

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix It
Incomplete HoFH diagnosis documentation Submit genetic testing results or detailed clinical criteria documentation
Missing background therapy trials Provide complete records of statin, ezetimibe, and PCSK9 inhibitor use with dates and outcomes
Insufficient LDL-C documentation Submit recent lipid panels showing current levels and response to prior treatments
Missing medical necessity justification Include detailed letter explaining why standard treatments are inadequate
Incorrect form or missing information Resubmit with complete Humana-specific PA form and all required attachments

Age-Specific Considerations

For children ages 5-9: Some Humana policies may not require PCSK9 inhibitor trials. Explicitly reference age-appropriate criteria in your submission to avoid unnecessary denials.

If You're Denied: Appeal Process

Internal Appeal (First Level)

Timeline: You have 65 days from your denial notice to file an internal appeal with Humana.

How to Submit:

  • Use the appeal form included with your denial notice
  • Include all original documentation plus any new supporting evidence
  • Request peer-to-peer review if your doctor wants to speak directly with Humana's medical director

Expedited Appeals

When to request: If waiting for standard review would seriously jeopardize your health.

Timeline: Humana must decide within 72 hours for expedited appeals.

Requirements: Include a letter from your doctor stating why delay would be harmful.

Michigan External Review

If Humana upholds their denial after internal appeal, Michigan residents have additional rights:

Timeline: 127 days from final internal denial to request external review through Michigan DIFS.

How to Submit:

Decision Timeline:

  • Standard external review: Up to 60 days
  • Expedited external review: 72 hours with physician urgency letter

Contact DIFS: 877-999-6442 for questions about the external review process.

Renewal and Re-Authorization

When to Resubmit

Most prior authorizations for Evkeeza require renewal every 6-12 months. Calendar a reminder 60 days before your current authorization expires.

What to Include for Renewal

  • Updated LDL-C levels showing continued need
  • Documentation of treatment response and tolerability
  • Any changes in clinical status or other medications
  • Confirmation that alternative treatments remain inappropriate

Patient Support and Cost Assistance

Manufacturer Programs

Regeneron offers patient support through their Evkeeza patient portal (verify current programs):

  • Prior authorization assistance
  • Insurance verification
  • Copay support for eligible patients
  • Care coordination services

Foundation Grants

Several rare disease foundations provide grants for HoFH treatments. Ask your healthcare team about current programs or search the National Organization for Rare Disorders (NORD) database.

FAQ: Common Questions

Q: How long does Humana prior authorization take for Evkeeza? A: Standard processing is typically 15 business days, but complex cases can take up to 30 days. Expedited reviews are completed within 72 hours when medical urgency is documented.

Q: What if Evkeeza isn't on Humana's formulary? A: As a specialty infusion drug covered under the medical benefit, traditional formulary status may not apply. However, you can still request a formulary exception if needed.

Q: Can I get an expedited appeal in Michigan? A: Yes, both Humana internal appeals and Michigan external reviews offer expedited options (72 hours) when your doctor documents that delay would harm your health.

Q: What counts as "maximally tolerated" background therapy? A: This typically means you've tried the highest doses of statin and ezetimibe you can tolerate, plus a PCSK9 inhibitor for at least 8 weeks, unless contraindicated or not tolerated.

Q: Do I need to try apheresis before Evkeeza? A: LDL apheresis is not typically required before Evkeeza, but some policies may prefer it for eligible patients. Check your specific Humana policy or discuss with your doctor.

Q: How much will I pay out-of-pocket? A: This depends on your specific Humana plan's medical benefit structure. Contact Humana member services for a benefits verification and estimated costs.

Quick Reference Checklist

Before Submitting:

  • Confirm HoFH diagnosis (genetic testing or clinical criteria)
  • Document all prior lipid-lowering therapies with dates and outcomes
  • Obtain recent LDL-C levels
  • Verify in-network infusion site
  • Complete Humana PA form
  • Prepare medical necessity letter

Submission Package:

  • Completed PA form with all required fields
  • Copy of insurance card
  • Genetic testing results or clinical diagnosis documentation
  • Complete treatment history records
  • Recent lab results
  • Medical necessity letter
  • NDC code included

After Submission:

  • Document submission date and method
  • Follow up after 10 business days if no response
  • Keep all correspondence and reference numbers
  • Calendar renewal reminder for 60 days before expiration

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed requests aligned to each payer's specific requirements. Our platform streamlines the prior authorization process by identifying denial patterns and crafting point-by-point rebuttals using the right clinical evidence and procedural requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and should not be considered medical or legal advice. Coverage decisions vary by individual circumstances and policy terms. Always consult with your healthcare provider about treatment decisions and contact your insurance company directly for specific coverage questions. For additional help with insurance appeals in Michigan, contact DIFS at 877-999-6442.

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