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

How to Get Evkeeza (Evinacumab) Approved by Aetna CVS Health in Pennsylvania: Prior Authorization Guide with Appeals Process

Answer Box: Getting Evkeeza Covered by Aetna in Pennsylvania

To get Evkeeza (evinacumab-dgnb) approved by Aetna CVS Health in Pennsylvania for homozygous familial hypercholesterolemia (HoFH):

  1. Confirm HoFH diagnosis with genetic testing or clinical criteria (untreated LDL-C >400 mg/dL plus family history/xanthomas)
  2. Document step therapy failures with maximally tolerated statins, ezetimibe, and PCSK9 inhibitors
  3. Submit Aetna's Evkeeza Precertification Request form via fax (1-888-267-3277) or phone (1-866-752-7021)

First step today: Download the Evkeeza precertification form and gather recent LDL-C lab results. If denied, Pennsylvania's external review process has a 50% overturn rate for specialty drug appeals.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather What You Need
  4. Step-by-Step: Submit Your Request
  5. Follow-Up and Timelines
  6. If You're Asked for More Information
  7. If Your Request is Denied
  8. Pennsylvania External Review Process
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This guide helps patients with homozygous familial hypercholesterolemia (HoFH) and their healthcare providers navigate Aetna CVS Health's prior authorization process for Evkeeza (evinacumab-dgnb) in Pennsylvania.

Evkeeza is an expensive specialty medication—around $450,000 annually—that requires careful documentation and often faces initial denials. However, with proper preparation and Pennsylvania's strengthened external review process, many patients successfully obtain coverage.

Who this helps:

  • Patients with HoFH needing Evkeeza coverage
  • Clinicians submitting prior authorizations
  • Caregivers navigating insurance appeals

Before You Start: Verify Your Coverage

Check Your Plan Type

Commercial Plans: Most Aetna commercial plans in Pennsylvania require prior authorization for Evkeeza. The drug typically appears on Tier 5 or 6 (specialty tiers) with higher cost-sharing.

Medicare Plans: Aetna Medicare Advantage plans may have different formulary placement. Check your specific plan's formulary.

Medicaid Plans: Aetna Better Health Pennsylvania follows state Medicaid guidelines with additional prior authorization requirements.

Confirm Formulary Status

Evkeeza requires prior authorization across all Aetna plan types. It's not available as a preferred drug, meaning you'll need to complete the full medical necessity review process.

Note: Self-funded employer plans may have different requirements. Check with your HR department if you're unsure about your plan type.

Gather What You Need

Essential Documentation

HoFH Diagnosis Confirmation:

  • Genetic testing results showing LDLR, APOB, PCSK9, or LDLRAP1 variants, OR
  • Clinical diagnosis with untreated LDL-C >400 mg/dL plus family history or xanthomas before age 10

Laboratory Results:

  • Most recent lipid panel with LDL-C levels
  • Historical LDL-C values showing treatment response
  • Date of each lab draw

Prior Therapy Documentation:

  • Statin trials: Maximum tolerated doses of high-intensity statins (atorvastatin 80mg, rosuvastatin 40mg)
  • Ezetimibe trial: Unless contraindicated
  • PCSK9 inhibitor trial: Evolocumab (Repatha) or alirocumab (Praluent) with documented inadequate response or intolerance

Patient Information:

  • Current height and weight (for dosing calculation)
  • ICD-10 diagnosis code (E78.01 for HoFH)
  • Allergies and contraindications
  • Prescriber NPI and contact information

Required Forms

Download the Evkeeza Medication Precertification Request form from Aetna's website. This form must be completed in full—incomplete submissions cause delays.

Step-by-Step: Submit Your Request

Step 1: Complete the Precertification Form

Fill out every section of Aetna's Evkeeza precertification form:

  • Patient demographics and insurance information
  • Diagnosis with ICD-10 code (E78.01)
  • Requested dose: 15 mg/kg IV every 4 weeks
  • Current LDL-C level and date obtained
  • Prior therapy attempts and outcomes

Step 2: Attach Supporting Documentation

Include:

  • Recent clinic notes documenting HoFH diagnosis
  • Laboratory reports with LDL-C values
  • Records of prior statin, ezetimibe, and PCSK9 inhibitor trials
  • Any genetic testing results

Step 3: Submit Via Preferred Method

Fax: 1-888-267-3277 (most reliable) Phone: 1-866-752-7021 for urgent requests Online: Through Aetna's provider portal if available

Tip: Submit at least two weeks before the intended start date to allow for processing time.

Step 4: Coordinate Site of Care

Aetna requires Evkeeza infusions at approved sites. Common options include:

  • Hospital outpatient infusion centers
  • Specialty clinics with infusion capabilities
  • CVS Specialty-contracted locations

The prescriber may need to specify the intended site of care on the authorization request.

Follow-Up and Timelines

Expected Processing Times

Standard Requests: 14 days for non-urgent cases Expedited Requests: 72 hours for urgent medical situations

When to Follow Up

Call Aetna at 1-888-632-3862 (commercial plans) if you haven't received a response within:

  • 7 days for expedited requests
  • 14 days for standard requests

Sample Follow-Up Script: "I'm calling to check the status of a prior authorization request for Evkeeza submitted on [date]. The patient name is [name] and member ID is [number]. Can you provide an update on the review status?"

Document all reference numbers and representative names for your records.

If You're Asked for More Information

Aetna may request additional clinical information, commonly:

Missing HoFH Documentation: Provide genetic testing results or detailed family history with untreated LDL-C levels Incomplete Step Therapy: Submit records showing adequate trials and failures of required medications Dosing Justification: Include current weight and confirm 15 mg/kg calculation

Respond promptly to information requests—delays can reset the review timeline.

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason Solution
Incomplete step therapy Provide documentation of statin, ezetimibe, and PCSK9 inhibitor trials
Missing HoFH confirmation Submit genetic testing or clinical criteria documentation
Non-formulary status Request formulary exception with medical necessity justification
Quantity limits exceeded Confirm appropriate weight-based dosing calculation

Internal Appeal Process

You have 180 days to file an internal appeal with Aetna. Submit:

  • Written appeal letter explaining medical necessity
  • Additional clinical documentation
  • Peer-reviewed literature supporting Evkeeza use in HoFH
  • Updated LDL-C levels if available

Appeal Submission:

  • Online through member portal
  • Mail to address on denial letter
  • Fax to number provided in denial notice

Pennsylvania External Review Process

If Aetna denies your internal appeal, Pennsylvania offers a robust external review process with strong patient outcomes.

Key Statistics

Pennsylvania's external review program has achieved a 50% overturn rate for specialty drug denials in 2024, meaning half of all appeals result in coverage approval.

Eligibility and Process

Who Can Use It: Commercial plan members (not self-funded ERISA plans) When to Apply: Within 4 months of receiving Aetna's final denial letter Cost: Free to patients

Timeline:

  1. File Request: Submit online at pa.gov external review portal
  2. Eligibility Review: Pennsylvania Insurance Department responds within 5 business days
  3. Submit Evidence: 15 days to provide additional documentation once IRO is assigned
  4. Decision: Independent Review Organization issues binding decision within 45 days

Expedited Reviews: Available for urgent cases with 72-hour decision timeline

Required Documentation

  • Aetna's final denial letter
  • All medical records supporting Evkeeza necessity
  • Clinical literature demonstrating effectiveness for HoFH
  • Prescriber's detailed medical necessity letter
Success Story: Pennsylvania's program helped over 250 patients in 2024 obtain coverage for previously denied treatments, including expensive specialty medications like Evkeeza.

Renewal and Re-Authorization

Evkeeza typically requires re-authorization every 6-12 months. Plan ahead by:

90 Days Before Expiration:

  • Schedule lipid panel to document ongoing need
  • Gather updated clinical notes
  • Confirm continued HoFH diagnosis

30 Days Before Expiration:

  • Submit renewal request with updated LDL-C levels
  • Include treatment response documentation
  • Note any dosing adjustments

Quick Reference Checklist

Before Submitting:

  • HoFH diagnosis confirmed (genetic or clinical criteria)
  • Recent LDL-C lab results obtained
  • Step therapy documentation complete (statin, ezetimibe, PCSK9 inhibitor)
  • Evkeeza precertification form fully completed
  • Site of care identified and approved
  • Supporting clinical notes attached

After Submission:

  • Reference number documented
  • Follow-up call scheduled for 7-14 days
  • Denial appeal timeline noted (180 days)
  • Pennsylvania external review option confirmed (4 months)

FAQ

How long does Aetna prior authorization take for Evkeeza in Pennsylvania? Standard requests take up to 14 days; expedited requests are processed within 72 hours for urgent medical situations.

What if Evkeeza is non-formulary on my Aetna plan? Request a formulary exception by demonstrating medical necessity and providing clinical documentation supporting HoFH diagnosis and prior therapy failures.

Can I request an expedited appeal if Aetna denies Evkeeza? Yes, if the delay could seriously jeopardize your health, both Aetna's internal process and Pennsylvania's external review offer expedited timelines.

Does step therapy apply if I've tried these medications outside Pennsylvania? Yes, Aetna accepts documentation of prior therapy trials from any location, as long as the records clearly show adequate trials and outcomes.

What's the success rate for Evkeeza appeals in Pennsylvania? Pennsylvania's external review program has a 50% overturn rate for specialty drug denials, providing a meaningful opportunity for coverage approval.

How much does Evkeeza cost without insurance? The average wholesale acquisition cost is approximately $450,000 annually, making insurance coverage essential for most patients.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed requests. The platform analyzes denial letters and plan policies, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For complex cases like Evkeeza prior authorizations, having expert support can significantly improve approval odds and reduce the time spent navigating insurance requirements.

From our advocates: We've seen cases where initial Evkeeza denials were overturned after providing comprehensive genetic testing documentation and detailed records of PCSK9 inhibitor trials. The key is often demonstrating that conventional therapies have been genuinely attempted at appropriate doses and durations, not just prescribed. This composite example reflects common patterns in successful appeals, though individual outcomes vary.

When facing an Evkeeza denial from Aetna in Pennsylvania, remember that you have multiple levels of appeal available, including the state's external review process with its encouraging 50% success rate. The combination of thorough clinical documentation, understanding of Aetna's specific requirements, and Pennsylvania's patient-friendly appeal system provides a strong foundation for obtaining coverage.

For additional support navigating complex prior authorizations and appeals, Counterforce Health offers specialized assistance in turning insurance denials into approvals through evidence-based appeal strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for specific coverage questions. For assistance with Pennsylvania insurance issues, contact the Pennsylvania Insurance Department at 1-877-881-6388.

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