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

Work With Your Doctor to Get Evkeeza (evinacumab-dgnb) Approved by UnitedHealthcare in New York: Complete Prior Authorization Guide

Answer Box: Getting Evkeeza Covered by UnitedHealthcare in New York

Evkeeza (evinacumab-dgnb) requires prior authorization from UnitedHealthcare for homozygous familial hypercholesterolemia (HoFH) patients ≥5 years old. Fastest path: Work with your specialist to submit a complete PA request including genetic confirmation of HoFH, documented failure of maximally tolerated therapy (statin + ezetimibe + PCSK9 inhibitor), and current LDL-C levels. If denied, file internal appeal within 180 days, then request external review through New York State Department of Financial Services within 4 months. Start today: Schedule appointment with your cardiologist or lipidologist to review your case and gather required documentation.

Table of Contents

  1. Set Your Goal: Understanding UnitedHealthcare's Requirements
  2. Visit Preparation: What to Bring to Your Appointment
  3. Building Your Evidence Kit
  4. Medical Necessity Letter Structure
  5. Supporting Your Doctor During Peer-to-Peer Review
  6. After-Visit Documentation
  7. Respectful Persistence: Following Up Effectively
  8. New York Appeals Process
  9. Common Denial Reasons & Solutions
  10. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all UHC plans UHC Provider Portal UHC Policy
Indication HoFH in patients ≥5 years FDA label, genetic testing UHC Policy
Prior Therapy Maximally tolerated statin + ezetimibe + PCSK9 inhibitor Medical records, pharmacy history UHC Policy
Prescriber Specialist (cardiologist, lipidologist, endocrinologist) Provider credentials UHC Policy
Appeal Deadline 180 days internal, 4 months external Denial letter, NY DFS NY DFS

Set Your Goal: Understanding UnitedHealthcare's Requirements

Getting Evkeeza approved by UnitedHealthcare requires a collaborative approach with your healthcare provider. Your role is to gather the right documentation and advocate for yourself, while your doctor provides the clinical expertise and medical necessity justification.

What UnitedHealthcare Looks For:

  • Confirmed diagnosis of homozygous familial hypercholesterolemia (HoFH)
  • Evidence of inadequate response to maximally tolerated lipid-lowering therapy
  • Specialist prescriber with expertise in lipid disorders
  • Clear documentation of medical necessity

The key is working as a team with your provider to present a complete, well-documented case that meets UnitedHealthcare's specific criteria for Evkeeza coverage.

Visit Preparation: What to Bring to Your Appointment

Before meeting with your cardiologist or lipidologist, gather these essential items:

Medical History Documentation

  • Genetic testing results showing pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Complete lipid panel history including:
    • Untreated or baseline LDL-C levels (ideally >400 mg/dL)
    • LDL-C levels on each medication regimen with dates
    • Most recent lipid panels showing persistent elevation
  • Family history details including relatives with early heart disease or familial hypercholesterolemia

Treatment Timeline

Create a chronological list of all lipid-lowering medications you've tried:

  • Drug names, doses, and duration of treatment
  • Reasons for discontinuation (ineffective, side effects, intolerance)
  • LDL-C response to each therapy
  • Current medications and adherence

Symptom and Impact Notes

Document how HoFH affects your daily life:

  • Physical symptoms (chest pain, shortness of breath)
  • Functional limitations
  • Quality of life impact
  • Concerns about cardiovascular risk
Tip: Write down your questions before the appointment. Include specific concerns about Evkeeza, such as infusion scheduling and expected outcomes.

Building Your Evidence Kit

Work with your healthcare team to compile comprehensive documentation that supports your Evkeeza request.

Clinical Evidence Checklist

  • ✅ Genetic confirmation: Bi-allelic pathogenic variants or clinical phenotype meeting HoFH criteria
  • ✅ Lipid panels: Serial LDL-C measurements showing inadequate control
  • ✅ Medication history: Documented trials of statin, ezetimibe, and PCSK9 inhibitor
  • ✅ Specialist evaluation: Assessment by cardiologist, lipidologist, or endocrinologist
  • ✅ Imaging studies: Cardiac catheterization, CT angiography, or carotid ultrasound if available

Published Guidelines to Reference

Your doctor may cite these in the medical necessity letter:

Supporting Laboratory Values

Ensure your doctor has access to:

  • Baseline LDL-C: Ideally >400 mg/dL untreated or >300 mg/dL on therapy
  • Current LDL-C: Despite maximally tolerated therapy
  • Additional markers: Total cholesterol, HDL-C, triglycerides, Lp(a) if available

Medical Necessity Letter Structure

The medical necessity letter is the cornerstone of your prior authorization request. Here's what your doctor should include:

Essential Components

1. Patient Demographics and Diagnosis

  • Clear statement: "Patient has homozygous familial hypercholesterolemia (HoFH)"
  • ICD-10 code: E78.010 (effective October 1, 2025)
  • Genetic confirmation or clinical criteria met

2. Clinical Rationale

  • Mechanism of action: Evkeeza works independently of LDL receptor function
  • FDA approval for HoFH as adjunctive therapy
  • Expected LDL-C reduction of approximately 47-50%

3. Prior Therapy Documentation

  • High-intensity statin trial with specific drug, dose, duration, and response
  • Ezetimibe trial with outcomes
  • PCSK9 inhibitor trial (≥8 weeks) with response or contraindication
  • Any other therapies attempted (lomitapide, apheresis)

4. Current Clinical Status

  • Most recent LDL-C level and date
  • Cardiovascular risk assessment
  • Functional status and quality of life impact

5. Treatment Plan

  • Evkeeza dosing: 15 mg/kg IV every 4 weeks
  • Continuation of background therapy
  • Monitoring plan and follow-up schedule
From Our Advocates: We've seen the strongest approvals when providers include a one-page summary table showing the patient's LDL-C journey—baseline levels, each medication tried with dates and responses, and current status. This visual timeline helps medical reviewers quickly understand why Evkeeza is necessary.

Supporting Your Doctor During Peer-to-Peer Review

If your initial prior authorization is denied, UnitedHealthcare may offer a peer-to-peer review with their medical director. Here's how you can help:

Before the Call

  • Provide availability windows when your doctor can take the call
  • Prepare a one-page case summary highlighting:
    • Confirmed HoFH diagnosis
    • Current LDL-C level despite maximal therapy
    • Cardiovascular risk factors
    • Why Evkeeza is uniquely appropriate

Key Talking Points for Your Provider

  • Emphasize that Evkeeza works via ANGPTL3 inhibition, independent of LDL receptor function
  • Reference UnitedHealthcare's own policy stating Evkeeza is "proven and medically necessary" for HoFH
  • Highlight the lack of viable formulary alternatives for HoFH patients

Documentation to Have Ready

  • Member ID and plan details
  • Genetic testing report
  • Complete medication history
  • Recent lipid panels
  • Cardiovascular imaging if available

After-Visit Documentation

After your appointment, ensure proper documentation and follow-up:

What to Save

  • Copy of the medical necessity letter
  • Prior authorization submission confirmation
  • All supporting documentation submitted
  • Provider's notes from your visit

Portal Communication

Use your patient portal to:

  • Message your provider with additional questions
  • Request copies of test results
  • Follow up on prior authorization status
  • Schedule infusion appointments if approved

Timeline Tracking

Keep a log of:

  • Prior authorization submission date
  • Expected decision timeline (typically 15 business days)
  • Follow-up dates and actions taken
  • Appeal deadlines if denied

Respectful Persistence: Following Up Effectively

Effective follow-up requires balance between advocacy and professionalism:

Appropriate Cadence

  • Week 1-2: Allow normal processing time
  • Week 3: Polite status inquiry via portal or phone
  • After denial: Immediate appeal preparation

Escalation Steps

  1. Provider follow-up: Ask your doctor to call UnitedHealthcare directly
  2. Peer-to-peer request: If available after denial
  3. Formal appeal: Within 180 days of denial
  4. External review: Through NY Department of Financial Services

Professional Communication Scripts

  • "I'm following up on the status of my Evkeeza prior authorization submitted on [date]. Can you provide an update?"
  • "My doctor believes this medication is medically necessary for my HoFH. What additional information would help with approval?"

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to craft targeted, evidence-backed responses. Their platform helps patients and providers navigate complex prior authorization requirements and appeal processes more effectively.

New York Appeals Process

New York offers robust patient protections for insurance appeals:

Internal Appeals (UnitedHealthcare)

  • Deadline: 180 days from denial
  • Process: Submit via UHC provider portal, mail, or fax
  • Timeline: Standard review within 30 days; expedited within 72 hours
  • Required documents: Denial letter, medical records, provider attestation

External Review (NY Department of Financial Services)

  • Eligibility: After final adverse determination from UHC
  • Deadline: 4 months from final denial
  • Process: Submit NY External Appeal Application
  • Timeline: 30 days standard; 72 hours expedited
  • Fee: Up to $25 (waived for financial hardship)

Expedited Appeals

Available when:

  • Patient's health is in serious jeopardy
  • Ongoing hospitalization required
  • Emergency follow-up needed
  • Non-formulary drug urgency

Contact: 888-990-3991 for expedited external appeals

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Unconfirmed HoFH Provide genetic testing or clinical criteria Bi-allelic pathogenic variants or LDL-C >400 mg/dL + family history
Insufficient prior therapy Document all medication trials Detailed history of statin, ezetimibe, PCSK9 inhibitor with doses, durations, responses
Non-specialist prescriber Transfer care or obtain consultation Referral to cardiologist, lipidologist, or endocrinologist
Missing medical necessity Strengthen clinical rationale Emphasize ANGPTL3 mechanism, HoFH severity, cardiovascular risk
Step therapy requirements Request exception Document contraindications or failures of preferred alternatives

FAQ

How long does UnitedHealthcare prior authorization take in New York? Standard prior authorization decisions are made within 15 business days. Urgent cases may be expedited to 72 hours with proper clinical justification.

What if Evkeeza is non-formulary on my plan? Request a formulary exception through your provider. Include medical necessity documentation showing why formulary alternatives are inappropriate for HoFH.

Can I request an expedited appeal if denied? Yes, if your health is in serious jeopardy or you need urgent treatment. Contact UnitedHealthcare and NY DFS for expedited review timelines.

Does step therapy apply if I've tried medications outside New York? Medical records from other states are typically accepted. Ensure your provider documents all prior therapies regardless of where they were prescribed.

What are my rights if UnitedHealthcare denies coverage? New York law provides strong appeal rights including internal appeals and external review through the Department of Financial Services. External reviewers' decisions are binding on insurers.

How much does Evkeeza cost without insurance? The average wholesale acquisition cost is approximately $450,000 per year. Manufacturer patient assistance programs may be available for eligible patients.

What support is available for navigating appeals? Community Health Advocates offers free counseling at 888-614-5400. Counterforce Health provides specialized support for complex drug appeals.

Can my provider bill for time spent on prior authorizations? Some administrative time may be billable depending on your plan. Discuss coverage for care coordination services with your provider's billing department.

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage varies by plan and individual circumstances.

Sources & Further Reading

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