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

How to Get Evkeeza (Evinacumab) Covered by Aetna CVS Health in Michigan: Prior Authorization, Appeals & Cost Guide

Answer Box: Getting Evkeeza Covered in Michigan

Evkeeza (evinacumab) requires prior authorization from Aetna CVS Health for homozygous familial hypercholesterolemia (HoFH). Your fastest path to approval: 1) Confirm HoFH diagnosis with genetic testing or clinical criteria, 2) Document failed trials of maximum-tolerated statins, ezetimibe, and PCSK9 inhibitors, 3) Submit PA request through Aetna's provider portal with complete medical records. If denied, you have 180 days to appeal internally, then 127 days for Michigan's external review through DIFS.

Table of Contents

  1. Plan Types & Network Requirements
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Setup
  5. Cost-Sharing Breakdown
  6. Step-by-Step Approval Process
  7. Appeals Process in Michigan
  8. Common Denial Reasons & Solutions
  9. Patient Assistance Programs
  10. FAQ

Plan Types & Network Requirements

Your Aetna plan type determines referral and network requirements for Evkeeza treatment:

Plan Type Specialist Referral Network Rules Prior Auth Required
HMO Required from PCP HAP network only Yes, through HAP
PPO Not required Michigan in-network only Yes, through Aetna
EPO Not required In-network only Yes, through Aetna
Note: HAP EPO and PPO members in Michigan must use HAP's authorization process, not Aetna's standard system.

For HMO members, you'll need a referral to see a lipidologist or cardiologist who specializes in HoFH. PPO and EPO members can self-refer but must stay in-network for coverage.

Formulary Status & Tier Placement

Evkeeza is typically placed on Tier 5 (preferred specialty) or Tier 6 (non-preferred specialty) in CVS Caremark formularies. This means higher cost-sharing compared to generic medications.

Alternative HoFH treatments that may have different tier placement include:

  • PCSK9 inhibitors (evolocumab, alirocumab)
  • Lomitapide (Juxtapid)
  • Ezetimibe plus high-intensity statins
  • LDL apheresis (covered as a medical benefit)

Your specific formulary tier can be verified through your member portal or by calling CVS Caremark customer service.

Prior Authorization Requirements

All Aetna plans require prior authorization for Evkeeza. The key clinical criteria include:

Medical Necessity Documentation

  • Confirmed HoFH diagnosis via genetic testing or clinical criteria (LDL-C >500 mg/dL untreated, tendon xanthomas, family history)
  • ICD-10 code E78.01 (familial hypercholesterolemia)
  • Prior therapy failures with maximum-tolerated doses of:
    • High-intensity statins (atorvastatin 80mg or rosuvastatin 40mg)
    • Ezetimibe 10mg daily
    • PCSK9 inhibitor (evolocumab or alirocumab)
  • Contraindications or intolerances to alternative therapies
  • Current lipid panel showing inadequate LDL-C reduction
  • Weight-based dosing calculation (15 mg/kg every 4 weeks)

Site of Care Requirements

Evkeeza must be administered at approved infusion centers or specialty clinics. Home infusion may require additional authorization.

Specialty Pharmacy Setup

CVS Specialty Pharmacy typically handles Evkeeza distribution for Aetna members. The setup process includes:

  1. Prescription routing from your prescriber to CVS Specialty
  2. Benefits verification and prior authorization submission
  3. Patient enrollment in CVS specialty services
  4. Infusion site coordination for administration
  5. Ongoing refill management and monitoring

Your prescriber's office will coordinate most of these steps, but you may need to complete patient intake forms and provide insurance information.

Cost-Sharing Breakdown

Specialty tier medications typically have the highest cost-sharing in Aetna plans:

  • Tier 5 (preferred specialty): $250-$350 copay per 30-day supply
  • Tier 6 (non-preferred specialty): Higher copay or 25-40% coinsurance
  • Deductible: May apply before copay/coinsurance kicks in
  • Out-of-pocket maximum: Annual limit that caps your total costs
Important: These are general ranges. Your exact costs depend on your specific plan design. Check your Summary of Benefits and Coverage (SBC) for precise amounts.

Step-by-Step Approval Process

Step 1: Gather Documentation (Patient & Clinic)

Timeline: 1-2 weeks
Documents needed:

  • Complete lipid panels (before and during prior therapies)
  • Genetic testing results (if available)
  • Prior therapy trial records with doses and durations
  • Documentation of side effects or contraindications

Step 2: Submit Prior Authorization (Prescriber)

Timeline: 1-3 business days
How to submit: Aetna provider portal or fax to precertification department
Required forms: Completed PA request with medical necessity letter

Step 3: Aetna Review Process

Timeline: 15-30 business days (standard), 72 hours (expedited)
What happens: Clinical pharmacists and medical directors review against coverage criteria

Step 4: Decision Notification

Timeline: 1-2 business days after decision
Next steps: If approved, proceed to specialty pharmacy setup. If denied, begin appeal process.

Appeals Process in Michigan

If your initial PA request is denied, Michigan law provides robust appeal rights:

Internal Appeal (Aetna)

  • Deadline: 180 days from denial notice
  • Timeline: 30-45 days for standard appeals, 72 hours for expedited
  • How to file: Aetna appeals portal or mail to address on denial letter
  • Required: Denial letter, additional medical records, physician letter of support

External Review (Michigan DIFS)

  • Deadline: 127 days after final internal denial
  • Timeline: 60 days (standard), 72 hours (expedited)
  • How to file: DIFS External Review Request form online or by mail
  • Cost: No charge to patient
  • Decision: Binding on Aetna if overturned
Tip: For expedited external appeals, your physician must provide a letter stating that delay would seriously jeopardize your health.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not medically necessary" Submit detailed lipid response data showing inadequate LDL-C reduction with prior therapies
"Step therapy not completed" Document trial and failure of statins, ezetimibe, and PCSK9 inhibitors with specific doses and durations
"Experimental/investigational" Cite FDA approval and include prescribing information
"Non-formulary" Request formulary exception with comparative effectiveness data vs. covered alternatives
"Site of care not approved" Work with Aetna to identify approved infusion centers in your area

Clinician Corner: Medical Necessity Letter Checklist

When drafting your medical necessity letter, include:

✅ HoFH diagnosis confirmation with genetic testing or clinical criteria
✅ Baseline and current lipid panels showing inadequate response
✅ Prior therapy details: specific medications, doses, durations, and outcomes
✅ Contraindications or intolerances to alternative treatments
✅ Treatment goals: target LDL-C levels and cardiovascular risk reduction
✅ Dosing rationale: weight-based calculation for 15 mg/kg q4 weeks
✅ Monitoring plan: lipid panels, infusion reaction assessment
✅ Guideline support: Reference AHA/ACC cholesterol guidelines and FDA labeling

Patient Assistance Programs

Regeneron Patient Assistance Program offers up to $25,000 per calendar year toward out-of-pocket costs including:

  • Copays and coinsurance
  • Deductible amounts
  • Annual out-of-pocket maximums

Eligibility requirements:

  • Commercial insurance coverage (not Medicare/Medicaid)
  • Income limits may apply
  • Must be prescribed Evkeeza for approved indication

How to apply: Complete application at evkeeza.com or call patient support services.

When to Escalate to Michigan Regulators

Contact Michigan Department of Insurance and Financial Services (DIFS) at 877-999-6442 if:

  • Aetna fails to respond within required timeframes
  • You believe the denial violates Michigan insurance law
  • You need help navigating the external review process
  • You want to file a complaint about claims handling

DIFS can investigate insurance practices and help resolve disputes outside the formal appeal process.

Frequently Asked Questions

Q: How long does Aetna prior authorization take for Evkeeza?
A: Standard PA requests take 15-30 business days. Expedited requests (for urgent medical situations) are processed within 72 hours.

Q: What if Evkeeza isn't on my Aetna formulary?
A: You can request a formulary exception by demonstrating medical necessity and failure of covered alternatives. Include comparative effectiveness data in your request.

Q: Can I get expedited appeals in Michigan?
A: Yes, both Aetna internal appeals and Michigan DIFS external reviews offer expedited processes (72 hours) when delay would seriously jeopardize your health.

Q: Does step therapy apply if I tried medications outside Michigan?
A: Yes, documented trials from any provider should count toward step therapy requirements. Ensure your medical records clearly document the medications, doses, durations, and outcomes.

Q: What happens if my appeal is denied?
A: After exhausting Aetna's internal appeals, you can file for external review through Michigan DIFS. Their decision is binding on Aetna if they overturn the denial.

Q: How much will Evkeeza cost me?
A: Costs vary by plan design but typically range from $250-$350+ per infusion for specialty tier coverage. Patient assistance programs can help reduce out-of-pocket expenses.

From Our Advocates

"We've seen the strongest approvals when providers submit comprehensive trial-and-failure documentation upfront rather than waiting for the denial. Include specific medication names, doses, duration of therapy, and quantified LDL-C responses. One case we reviewed had a reversal on appeal simply because the physician added the patient's weight-based dosing calculation and cited the FDA prescribing information directly."

Getting specialized treatments like Evkeeza approved requires persistence and thorough documentation, but Michigan patients have strong appeal rights when denials occur. Counterforce Health helps patients and providers navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify the specific reasons for denial, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements.

For patients facing Evkeeza denials, the key is understanding your plan's specific requirements and building a comprehensive case that addresses each coverage criterion. With proper documentation and strategic appeals, many initially denied specialty medications can ultimately be approved.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult your healthcare provider and insurance plan documents for personalized guidance. For assistance with insurance appeals and coverage issues, Counterforce Health provides specialized support for patients and clinicians navigating prior authorization and appeals processes.

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