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

Get Evkeeza (Evinacumab) Covered by UnitedHealthcare in Pennsylvania: Step-by-Step Approval Guide

Quick Answer: Getting Evkeeza Covered in Pennsylvania

To get Evkeeza (evinacumab) approved by UnitedHealthcare in Pennsylvania, you need: confirmed HoFH diagnosis with LDL-C >400 mg/dL, documented failures of maximum-tolerated statins/ezetimibe/PCSK9 inhibitors, and prior authorization through the UnitedHealthcare Provider Portal. If denied, Pennsylvania's new external review process has a 53% overturn rate. Start by gathering genetic testing results, recent lipid panels, and prior therapy records. Call myRARE Patient Support at 1-877-385-3392 for copay assistance up to $25,000 annually.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step Approval Process
  3. Common Denial Reasons & Solutions
  4. Pennsylvania Appeals Process
  5. Patient Assistance Programs
  6. Clinician Documentation Tips
  7. When to Escalate
  8. FAQ

Coverage Requirements at a Glance

Requirement What UnitedHealthcare Needs Where to Find It Source
Prior Authorization Required for all plans UnitedHealthcare Provider Portal UHC PA Requirements
HoFH Diagnosis Genetic confirmation + LDL-C >400 mg/dL Genetic testing report Quest Diagnostics FH Guide
Step Therapy Documented failures of statins, ezetimibe, PCSK9 inhibitors Medical records OptumRx Formulary
Site of Care Specialty pharmacy required Prescription routing UHC Specialty Drugs

Step-by-Step Approval Process

1. Confirm HoFH Diagnosis

Who: Clinician
Document needed: Genetic testing showing two pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1
Timeline: 2-4 weeks for results

Order comprehensive familial hypercholesterolemia genetic panel if not already done. UnitedHealthcare typically covers genetic testing when LDL-C is >400 mg/dL untreated with family history of early cardiovascular disease.

2. Document Background Therapy Failures

Who: Clinician
Document needed: Medical records showing maximum-tolerated doses and outcomes
Timeline: Ongoing documentation

Record specific medications, doses, duration, and reasons for discontinuation (inefficacy, intolerance, contraindications). Include:

  • High-intensity statins (atorvastatin 40-80mg, rosuvastatin 20-40mg)
  • Ezetimibe 10mg daily
  • PCSK9 inhibitors (evolocumab, alirocumab) if accessible
  • LDL apheresis consideration if available

3. Gather Required Labs

Who: Clinician
Document needed: Recent lipid panel (within 3 months)
Timeline: Same day to 1 week

Obtain fasting lipid panel showing current LDL-C levels despite maximum background therapy. Include historical values demonstrating persistent elevation.

4. Submit Prior Authorization

Who: Clinician or staff
Document needed: PA request with supporting documentation
How to submit: UnitedHealthcare Provider Portal or call 888-397-8129
Timeline: 5-15 business days for decision

Submit through the provider portal with all supporting documents. Include diagnosis codes (E78.01 for familial hypercholesterolemia), medication details (NDC, dosing), and clinical justification.

5. Review Decision

Who: Clinician and patient
Document needed: PA determination letter
Timeline: Immediate upon receipt

If approved, coordinate with specialty pharmacy for delivery. If denied, review specific reasons cited and prepare appeal within 24 hours for peer-to-peer review opportunity.

Tip: Pennsylvania patients have strong appeal rights. The state's new external review process overturns 53% of denials, so don't give up after an initial "no."

Common Denial Reasons & Solutions

Denial Reason Solution Required Documents
"Not medically necessary" Peer-to-peer review emphasizing HoFH severity Genetic testing, family history, CV risk assessment
"Step therapy not completed" Document contraindications or failures Detailed medication history with outcomes
"Quantity limits exceeded" Request exception based on weight-based dosing Patient weight, BSA calculation, dosing rationale
"Non-formulary status" Medical exception request Comparative effectiveness data, formulary alternatives tried

Pennsylvania Appeals Process

Pennsylvania launched its Independent External Review Program in January 2024, giving patients powerful new appeal rights.

Internal Appeals (First Step)

  • Timeline: Must request within timeframes specified in denial letter
  • How to file: UnitedHealthcare member portal or written request
  • Decision deadline: 30 days for standard, 72 hours for urgent
  • Success rate: Variable, but required before external review

External Review (Pennsylvania-Specific)

  • Eligibility: Must complete internal appeals first
  • Timeline: Request within 4 months of final denial
  • How to file: Pennsylvania Insurance Department portal
  • Decision timeline: 45 days standard, 72 hours expedited
  • Success rate: 53% overturn rate in first year
  • Cost: Free to patients

The external review process is particularly valuable for expensive specialty drugs like Evkeeza, where independent medical reviewers often find in favor of patients with proper documentation.

From our advocates: We've seen several Pennsylvania patients successfully overturn Evkeeza denials through the state's external review process. The key was submitting comprehensive genetic testing results and detailed documentation of prior therapy failures within the 15-day window after IRO assignment. While outcomes vary, having an independent medical reviewer evaluate the case often leads to approval when the clinical need is clear.

Patient Assistance Programs

myRARE Patient Support Program

Regeneron offers comprehensive support for Evkeeza patients:

  • Commercial copay assistance: Up to $25,000 annually, potentially reducing copay to $0
  • Patient Assistance Program: Up to 12 months free for uninsured/underinsured patients with household income ≤$100,000 or 500% Federal Poverty Level
  • Bridge therapy: Free medication during insurance approval delays
  • Contact: 1-877-EVKEEZA (1-877-385-3392)

Enrollment Process

Complete the myRARE Start Form with your healthcare provider. A Patient Navigator will conduct benefits verification and determine eligibility for all available programs. UnitedHealthcare patients with approved coverage typically qualify for copay assistance.

Counterforce Health helps patients navigate these complex approval processes by turning insurance denials into targeted, evidence-backed appeals. The platform identifies specific denial reasons and drafts point-by-point rebuttals aligned to each payer's requirements, significantly improving approval odds for specialty medications like Evkeeza.

Clinician Documentation Tips

Medical Necessity Letter Checklist

Your letter to UnitedHealthcare should include:

Patient Background:

  • Confirmed HoFH diagnosis with genetic testing results
  • Family history of premature cardiovascular disease
  • Current cardiovascular risk stratification

Treatment History:

  • Specific medications tried, doses, duration
  • Reasons for discontinuation (side effects, contraindications, inadequate response)
  • Current LDL-C levels despite maximum background therapy

Clinical Rationale:

  • Why Evkeeza is medically necessary for this patient
  • Expected outcomes and monitoring plan
  • Reference to FDA labeling and clinical guidelines

Supporting Evidence: Include citations from:

Peer-to-Peer Review Strategy

If your initial PA is denied, request a peer-to-peer review within 24 hours. Prepare by:

  • Reviewing UnitedHealthcare's specific denial reasons
  • Gathering additional supporting literature
  • Preparing to discuss alternative therapy contraindications
  • Having patient's complete medical history readily available

Schedule through the UnitedHealthcare Provider Portal and provide multiple available time slots for flexibility.

When to Escalate

Contact the Pennsylvania Insurance Department if:

  • UnitedHealthcare fails to meet decision deadlines
  • You encounter procedural barriers in the appeals process
  • You need guidance on external review submission

Pennsylvania Insurance Department Consumer Services:

FAQ

How long does UnitedHealthcare prior authorization take in Pennsylvania? Standard PA decisions are issued within 5-15 business days. Urgent requests requiring expedited review are decided within 72 hours.

What if Evkeeza is non-formulary on my UnitedHealthcare plan? Request a medical exception by documenting that formulary alternatives are contraindicated, ineffective, or inappropriate for HoFH treatment.

Can I get expedited appeals in Pennsylvania? Yes, for urgent medical situations where delays could seriously jeopardize health. Both UnitedHealthcare internal appeals and Pennsylvania external reviews offer expedited timelines.

Does step therapy apply if I tried medications outside Pennsylvania? Yes, documented treatment history from any state counts toward step therapy requirements. Ensure your new Pennsylvania provider has complete medical records.

What happens if my external review is successful? UnitedHealthcare must immediately provide coverage, including retroactive payment if you paid out-of-pocket during the appeal process.

How much does Evkeeza cost without insurance? The average wholesale acquisition cost is approximately $450,000 annually based on weight-based dosing. Patient assistance programs can significantly reduce or eliminate out-of-pocket costs.

Can specialty pharmacies help with prior authorization? Many specialty pharmacies offer prior authorization support services and can coordinate with Counterforce Health or similar platforms to improve approval success rates.

What if I'm on Medicare Advantage with UnitedHealthcare? The same PA requirements apply, but you may have additional appeal rights under Medicare regulations. The 2025 Medicare Part D redesign includes a $2,000 out-of-pocket maximum for specialty drugs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan terms. Always consult with your healthcare provider and insurance company for personalized guidance. For additional support with insurance appeals, consider consulting with patient advocacy services or healthcare coverage specialists.

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