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

UnitedHealthcare's Coverage Criteria for Evkeeza in Texas: What Counts as "Medically Necessary"?

Answer Box: Getting Evkeeza Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Evkeeza (evinacumab-dgnb) with strict medical necessity criteria. You'll need documented homozygous familial hypercholesterolemia (HoFH), genetic testing or LDL-C ≥300 mg/dL on maximally tolerated therapy, and evidence of failed standard treatments. First step: Have your doctor submit a prior authorization request through the UnitedHealthcare Provider Portal with complete clinical documentation. If denied, you have 180 days to appeal in Texas, with expedited review available within 72 hours for urgent cases.

Table of Contents

Policy Overview

UnitedHealthcare covers Evkeeza under their specialty drug policy across all plan types in Texas—HMO, PPO, and Medicare Advantage. The drug requires prior authorization regardless of your plan structure, with OptumRx managing specialty pharmacy benefits for most members.

Key policy points:

  • Prior authorization mandatory before first dose
  • Step therapy requirements apply (must try other treatments first)
  • In-network specialty pharmacy required for dispensing
  • Site of care restrictions favor outpatient infusion centers over hospitals
  • Renewal authorization needed every 6-12 months with documented response

Find your specific plan's formulary and coverage details through your member portal or by calling the number on your insurance card.

Indication Requirements

Evkeeza is FDA-approved specifically for homozygous familial hypercholesterolemia (HoFH) in patients aged 5 and older. UnitedHealthcare follows this narrow indication strictly—off-label use for other cholesterol conditions typically isn't covered.

Diagnosis documentation must include:

  • ICD-10 code E78.01 (familial hypercholesterolemia)
  • Clear statement of "homozygous familial hypercholesterolemia" in clinical notes
  • Specialist confirmation (cardiologist, lipidologist, or endocrinologist preferred)

The diagnosis can be established through genetic testing or clinical criteria, but genetic confirmation strengthens your case significantly.

Step Therapy & Exceptions

UnitedHealthcare requires patients to try and fail standard lipid-lowering treatments before approving Evkeeza. This "step therapy" protocol includes:

Required prior treatments:

  1. Statin therapy at maximally tolerated dose for ≥8 weeks
  2. Ezetimibe (Zetia) for ≥8 weeks
  3. PCSK9 inhibitor (evolocumab/alirocumab) for ≥8 weeks (ages 10+)

Medical exceptions available if:

  • Previous treatments caused serious side effects
  • Medical contraindications exist (documented allergies, drug interactions)
  • Patient has two LDL-receptor negative alleles (genetic testing required)
Tip: For pediatric patients ages 5-9, PCSK9 inhibitor trials aren't required, making approval potentially faster.

Document each failed treatment with specific dates, doses, duration, and reason for discontinuation (lack of efficacy vs. intolerance).

Required Diagnostics

UnitedHealthcare expects comprehensive lab work and genetic testing to support medical necessity. Here's what your doctor needs to document:

Laboratory requirements:

  • Baseline LDL-C (untreated, if available)
  • Current LDL-C on maximally tolerated therapy (must remain elevated)
  • Complete lipid panel within 30 days of request
  • Liver function tests (baseline safety)

Genetic testing criteria:

  • Preferred: Confirmed pathogenic mutations in LDLR, PCSK9, APOB, or LDLRAP1 genes
  • Alternative: LDL-C ≥300 mg/dL despite maximal therapy in absence of secondary causes

Additional documentation:

  • Patient weight (for dosing calculations)
  • Blood pressure and cardiovascular risk assessment
  • Evidence of xanthomas or premature cardiovascular disease

Keep lab results current—UnitedHealthcare may request updated values during the review process.

Site of Care Requirements

UnitedHealthcare implements strict site-of-care management to control costs. Evkeeza must be administered in approved locations:

Preferred sites:

  • Physician office infusion suites
  • Standalone infusion centers
  • Specialty clinics with IV capabilities

Restricted sites:

  • Hospital outpatient departments (requires special justification)
  • Emergency departments
  • Inpatient settings (unless medically necessary)

Specialty pharmacy requirements:

  • Must use UnitedHealthcare's in-network specialty pharmacy
  • Drug shipped directly to infusion site
  • Buy-and-bill model through medical benefit
  • Out-of-network pharmacies generally not covered

Coordinate with your infusion center to ensure they're contracted with UnitedHealthcare's preferred specialty pharmacy network before scheduling treatment.

Evidence to Support Necessity

Strong clinical evidence significantly improves approval chances. Include these key references in your medical necessity letter:

Primary evidence sources:

  • FDA prescribing information for Evkeeza
  • 2018 AHA/ACC Cholesterol Guidelines recommending aggressive treatment for HoFH
  • European Atherosclerosis Society consensus statements on HoFH management

Clinical rationale to emphasize:

  • Extremely high cardiovascular risk without treatment
  • Unique mechanism of action (ANGPTL3 inhibition) for LDLR-independent LDL-C reduction
  • Limited alternative therapies for true HoFH patients
  • Progressive atherosclerotic disease despite maximal conventional therapy
Note: Counterforce Health helps clinicians identify the most compelling evidence for each patient's specific situation, turning insurance denials into targeted, evidence-backed appeals.

Sample Medical Necessity Narrative

Here's a template paragraph structure for your doctor's letter:

"This 32-year-old patient has genetically confirmed homozygous familial hypercholesterolemia with compound heterozygous mutations in the LDLR gene (c.1234A>G and c.5678C>T). Despite maximally tolerated combination therapy including atorvastatin 80mg daily, ezetimibe 10mg daily, and evolocumab 140mg every two weeks for the past six months, LDL cholesterol remains severely elevated at 285 mg/dL (goal <100 mg/dL). The patient has developed tendon xanthomas and has a strong family history of premature coronary artery disease. Evkeeza represents the only remaining therapeutic option to achieve meaningful LDL-C reduction and prevent inevitable cardiovascular events. The requested dosing of 15 mg/kg IV every 4 weeks aligns with FDA-approved labeling for this rare, life-threatening condition."

This structure addresses diagnosis, genetics, prior treatments, current status, clinical urgency, and dosing rationale in a single paragraph.

Pediatric Considerations

UnitedHealthcare covers Evkeeza for children as young as 5 years old, with modified criteria:

Ages 5-9 years:

  • No PCSK9 inhibitor trial required
  • Genetic confirmation strongly preferred
  • Weight-based dosing (15 mg/kg IV every 4 weeks)
  • Goal LDL-C reduction to <115 mg/dL

Ages 10+ years:

  • Standard adult criteria apply
  • PCSK9 inhibitor trial required unless contraindicated
  • Same genetic and laboratory documentation needed

Pediatric-specific documentation:

  • Growth parameters and developmental history
  • Family pedigree showing HoFH inheritance pattern
  • Pediatric cardiology consultation recommended
  • Discussion of long-term cardiovascular risk

Children often have faster approval timelines due to the severity of untreated HoFH and limited alternative therapies.

Appeals Playbook for Texas

When UnitedHealthcare denies your Evkeeza request, Texas law provides strong appeal rights:

Internal Appeals Process

Standard Appeal:

  • Deadline: 180 days from denial notice
  • Timeline: UnitedHealthcare responds within 30 days
  • How to file: Provider Portal or written request
  • Required: Appointment of Representative form if provider appeals for patient

Expedited Appeal:

  • When to use: Delay would seriously jeopardize health
  • Timeline: 72 hours for UnitedHealthcare response
  • How to file: Same methods as standard, mark "URGENT"
  • Documentation: Medical statement of urgency required

External Review (Texas)

If internal appeals fail, Texas offers independent review:

Eligibility: Medical necessity denials for state-regulated plans Deadline: 4 months from final internal denial Process: Texas Department of Insurance contracts Independent Review Organizations Cost: Free to patient (insurer pays) Timeline: 20 days standard, 5 days for urgent cases

Contact for help:

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742
Important: ERISA self-funded employer plans follow federal appeals rules, not Texas state law.

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
"Not FDA-approved indication" Confirm HoFH diagnosis Genetic testing or clinical criteria
"Step therapy not completed" Document prior failures Medication history with dates/outcomes
"Lack of medical necessity" Strengthen clinical rationale Updated labs, specialist letter, guidelines
"Site of care not approved" Switch to preferred location Contract with in-network infusion center
"Non-network pharmacy" Use approved specialty pharmacy Coordinate with UnitedHealthcare's network
"Insufficient genetic evidence" Obtain molecular confirmation LDLR/PCSK9/APOB/LDLRAP1 gene testing

For complex denials, Counterforce Health can help identify the specific denial basis and draft targeted rebuttals using your plan's own coverage criteria.

FAQ

How long does UnitedHealthcare prior authorization take for Evkeeza in Texas? Standard requests take up to 14 days, but complex cases requiring additional documentation can take 30 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Evkeeza isn't on my UnitedHealthcare formulary? Evkeeza requires prior authorization regardless of formulary status. Non-formulary drugs can still be covered with strong medical necessity documentation and completed step therapy.

Can I get an expedited appeal if my initial request is denied? Yes, if waiting for a standard appeal would seriously jeopardize your health. Your doctor must provide written documentation of medical urgency.

Does UnitedHealthcare cover Evkeeza for heterozygous FH? No, coverage is limited to homozygous familial hypercholesterolemia (HoFH) only. Heterozygous FH patients should try PCSK9 inhibitors first.

What happens if I start Evkeeza before getting prior authorization? UnitedHealthcare won't cover services provided before PA approval. You could be responsible for the full cost (approximately $450,000 annually).

How often do I need to renew Evkeeza authorization? Most approvals are for 6-12 months, requiring renewal with documented clinical response (LDL-C reduction, medication adherence >85%, continued medical necessity).

This guide provides educational information only and doesn't constitute medical or legal advice. Always consult your healthcare provider and insurance company for personalized guidance. For additional help with Texas insurance appeals, contact the Texas Department of Insurance at 1-800-252-3439.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify specific coverage criteria, then drafts point-by-point rebuttals using the right medical evidence and clinical documentation.

Sources & Further Reading

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