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

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

Answer Box: Fastest Path to Evkeeza Coverage

Humana requires prior authorization for Evkeeza (evinacumab-dgnb) as a Tier 5 specialty medication. To get approved in California: 1) Gather HoFH diagnosis documentation (genetic testing showing pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes, plus LDL-C >400 mg/dL untreated), 2) Document failure/intolerance to maximally tolerated background therapies (statins, ezetimibe, PCSK9 inhibitors), and 3) Submit PA via Humana provider portal with specialist prescription. If denied, you have 65 days to appeal and can request California's Independent Medical Review (IMR) through DMHC for binding external review.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana Medicare Advantage and Part D plans Humana provider portal 2026 Medicare Prior Authorization List
Formulary Status Tier 5 specialty medication Plan formulary documents Humana Drug List
HoFH Diagnosis Genetic confirmation or clinical criteria Genetic testing report FDA Evkeeza Label
Age Requirement ≥5 years old Prescriber documentation FDA approval criteria
Specialist Prescriber Lipidologist, cardiologist, or endocrinologist Provider credentials Humana coverage policy
Background Therapy Maximum tolerated statins, ezetimibe, PCSK9 inhibitor Treatment history records Clinical documentation

Step-by-Step: Fastest Path to Approval

1. Confirm HoFH Diagnosis (Patient/Clinic)

What you need: Genetic testing showing two pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes, OR clinical criteria (untreated LDL-C >400 mg/dL plus family history/xanthomas). Timeline: 2-4 weeks for genetic testing results Submit to: Include in PA submission package

2. Document Prior Therapy Failures (Clinic)

What you need: Records showing ≥3 months of two different statins, ≥8 weeks statin + ezetimibe, and ≥3 months PCSK9 inhibitor with dates, doses, and reasons for discontinuation. Timeline: Gather from patient records Submit to: Humana PA review team

3. Obtain Current Labs (Patient/Clinic)

What you need: LDL-C levels within 90 days showing >250 mg/dL on therapy or >400 mg/dL untreated. Timeline: 1-2 days for lab results Submit to: Include with PA documentation

4. Submit Prior Authorization (Specialist)

What you need: Complete PA form via Humana provider portal with all supporting documentation. Timeline: 1 business day for electronic submission, 30 days for standard decision Submit to: Humana Provider Portal or call 1-800-555-2546

5. Monitor PA Status (Clinic Staff)

What you need: Check portal every 2-3 days, respond to information requests promptly. Timeline: Ongoing during review period Submit to: Respond via same portal

6. If Denied, File Internal Appeal (Patient/Clinic)

What you need: Denial letter, updated medical necessity letter, additional clinical evidence. Timeline: Submit within 65 days of denial notice Submit to: Humana appeals department via portal, phone, or mail

7. Request California IMR if Needed (Patient)

What you need: Complete internal appeal first, then file IMR application with DMHC. Timeline: Within 6 months of denial, 45 days for standard IMR decision Submit to: DMHC HealthHelp.ca.gov

Understanding Your Denial Letter

When Humana denies your Evkeeza prior authorization, the denial letter will include specific reason codes. Here's how to decode the most common ones:

Medical Necessity Denial: Humana determined the medication isn't medically necessary based on their coverage criteria. This often means missing documentation of HoFH diagnosis or inadequate prior therapy trials.

Non-Formulary Status: While Evkeeza is on Humana's formulary as Tier 5, specific plan variations may require formulary exceptions.

Step Therapy Requirements: You must try and fail other cholesterol medications before Evkeeza is covered, unless contraindicated.

Quantity Limits: Humana limits Evkeeza to one 15 mg/kg dose every 4 weeks based on FDA dosing guidelines.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Incomplete HoFH diagnosis Submit genetic testing results or detailed clinical criteria documentation Pathogenic variant report, untreated LDL-C >400 mg/dL, family history
Insufficient prior therapy Provide complete treatment history with dates, doses, and outcomes Pharmacy records, provider notes, adverse event documentation
Missing current labs Submit recent LDL-C levels within 90 days Lab reports showing persistent elevation despite therapy
Non-specialist prescriber Have lipidologist, cardiologist, or endocrinologist submit PA Provider credentials, specialist consultation notes
Incomplete submission Ensure all required fields and supporting documents are included Complete PA form, medical records, FDA labeling references
From our advocates: We've seen many Evkeeza denials overturned when families worked closely with their specialist to document the complete treatment journey. One key tip: organize prior therapy records chronologically with clear start/stop dates and specific reasons for discontinuation. This creates a compelling narrative that reviewers can easily follow and helps establish medical necessity more effectively.

Appeals Playbook for Humana in California

Internal Appeals (Level 1)

Deadline: 65 days from denial notice date Timeline: 30 days for standard decision, 72 hours for expedited How to file:

  • Online: Humana member portal
  • Phone: 1-800-HUMANA (1-800-486-2621)
  • Mail: Humana Grievances and Appeals, P.O. Box 14546, Lexington, KY 40512-4546

Required documents:

  • Original denial letter
  • Updated medical necessity letter addressing specific denial reasons
  • Additional clinical evidence (new labs, specialist notes, treatment failures)
  • Patient identification (Humana member ID, name, DOB)

Peer-to-Peer Review

If your written appeal is denied, request a peer-to-peer review where your prescribing physician speaks directly with a Humana medical director. Include this request in your appeal: "I request review by a physician adviser not involved in the original decision."

Preparation checklist for prescribers:

  • Complete medical file review
  • Key talking points on Evkeeza necessity
  • Reference to FDA labeling and clinical guidelines
  • Documentation of HoFH severity and treatment failures
  • Alternative treatment considerations and contraindications

External Review: California IMR

California's Department of Managed Health Care (DMHC) provides Independent Medical Review (IMR) for Humana Medicare Advantage plans when medical necessity is disputed.

Eligibility: Must complete internal appeal with Humana first Deadline: 6 months from final internal denial Timeline: 45 days for standard IMR, 7 days for expedited Cost: Free to patients Success rates: 55-69% of medical necessity denials overturned based on available DMHC data

How to file:

  • Online: HealthHelp.ca.gov
  • Phone: DMHC Help Center at 1-888-466-2219
  • Mail: Submit IMR application with supporting documents

Required documents:

  • Humana's final denial letter
  • Complete medical records
  • Physician support letter emphasizing medical necessity
  • Alternative treatment plan if applicable

At Counterforce Health, we specialize in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create compelling appeals that align with each payer's specific criteria.

Medical Necessity Letter Checklist

When appealing an Evkeeza denial, your medical necessity letter should include:

Patient Problem:

  • Confirmed HoFH diagnosis with genetic testing results
  • Current LDL-C levels despite maximum therapy
  • Cardiovascular risk assessment and prognosis

Prior Treatments and Outcomes:

  • Complete chronology of lipid-lowering therapies tried
  • Specific medications, doses, duration, and reasons for discontinuation
  • Documentation of adverse events or contraindications
  • Response to previous treatments (lab values before/after)

Clinical Rationale:

  • Why Evkeeza is medically necessary for this specific patient
  • Expected clinical benefits (LDL-C reduction goals)
  • Risks of not treating or delaying treatment
  • Why alternative treatments are inappropriate

Guideline Citations:

Dosing and Monitoring:

  • Proposed dosing schedule (15 mg/kg IV every 4 weeks)
  • Monitoring plan for efficacy and safety
  • Treatment goals and success metrics

Costs & Patient Support Options

Manufacturer Support: Regeneron offers the EVKEEZA Co-pay Program for eligible patients with commercial insurance. Visit Evkeeza.com for enrollment information and eligibility requirements.

Foundation Assistance:

  • Patient Advocate Foundation: Financial assistance for chronic disease treatments
  • National Lipid Association Patient Support: Resources for familial hypercholesterolemia
  • HealthWell Foundation: May provide copayment assistance for qualifying patients

California-Specific Programs:

  • Medi-Cal coverage for eligible low-income patients
  • California Department of Insurance consumer assistance hotline: 1-800-927-4357

Frequently Asked Questions

How long does Humana prior authorization take for Evkeeza in California? Standard PA decisions are made within 30 days of complete submission. Expedited reviews for urgent medical situations are completed within 72 hours. Electronic submissions through the provider portal typically receive faster processing.

What if Evkeeza is non-formulary on my specific Humana plan? Even if not on your plan's formulary, you can request a formulary exception based on medical necessity. Submit the same documentation required for PA along with a formulary exception request explaining why covered alternatives are inappropriate.

Can I request an expedited appeal if I'm already on Evkeeza? Yes, if discontinuing treatment would jeopardize your health or life, you can request an expedited appeal. Your prescriber must document the urgency and potential medical consequences of treatment interruption.

Does step therapy apply if I failed therapies outside California? Prior therapy failures from any state count toward meeting Humana's step therapy requirements. Ensure you have documentation of the treatments tried, including dates, doses, and reasons for discontinuation.

What happens if California IMR upholds Humana's denial? IMR decisions are binding on health plans. If the IMR upholds the denial, you may explore alternative treatments, seek a second opinion, or consider changing insurance plans during the next open enrollment period.

How do I track my appeal status? Use Humana's online member portal or call the customer service number on your insurance card. Keep detailed records of all communications, including dates, representative names, and reference numbers.

Can my doctor bill for the peer-to-peer review call? Peer-to-peer reviews are not separately billable and are considered part of the appeals process. However, the time spent preparing for and conducting the call may be factored into overall case management.

What if I need Evkeeza while my appeal is pending? For urgent situations, request an expedited appeal and ask your prescriber to document the medical urgency. You may also explore temporary coverage options through manufacturer patient assistance programs or discuss alternative treatments with your specialist.

For complex cases requiring detailed appeal preparation, Counterforce Health offers specialized support in developing evidence-backed appeals that align with payer-specific requirements and procedural timelines.

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 plan for specific coverage decisions. Coverage policies and procedures may change. Verify current requirements with Humana and California regulatory agencies before taking action.

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