By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (Lomitapide) Covered by UnitedHealthcare in Washington: Complete Coverage Guide with Forms and Appeals

Answer Box: UnitedHealthcare requires prior authorization for Juxtapid (lomitapide) in Washington with strict criteria: confirmed HoFH diagnosis (genetic testing or untreated LDL-C >400 mg/dL plus clinical markers), documented failure of both Repatha and Evkeeza, REMS-certified specialist prescriber, and baseline liver function tests. Submit via OptumRx portal with genetic results, lipid panels, and specialist documentation. If denied, you have 180 days for internal appeals, then external review through Washington's IRO system. Start today: Contact a REMS-certified cardiologist or lipid specialist and gather genetic testing or LDL-C records >400 mg/dL.

Table of Contents

UnitedHealthcare Policy Overview

UnitedHealthcare covers Juxtapid (lomitapide) through OptumRx pharmacy benefits for members with confirmed homozygous familial hypercholesterolemia (HoFH). The drug requires prior authorization across all plan types—commercial HMO/PPO, Medicare Advantage, and Medicaid Community Plan—due to its specialty status and hepatotoxicity risk.

In Washington, UnitedHealthcare follows updated criteria effective February 2025 that streamlined genetic testing requirements while maintaining strict step therapy protocols. The policy applies to both initial authorizations (12-month approvals) and reauthorizations.

Note: Self-funded employer plans may have different criteria. Check your Summary Plan Description or contact member services to confirm coverage rules.

Medical Necessity Requirements

HoFH Diagnosis Confirmation

UnitedHealthcare accepts HoFH diagnosis through either genetic or clinical criteria:

Genetic Confirmation (Preferred):

  • Bi-allelic pathogenic or likely pathogenic variants on different chromosomes at LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Submit genetic test results with medical records and chart notes

Clinical Criteria (Both Required):

  • Untreated LDL cholesterol >400 mg/dL
  • Plus either:
    • Xanthoma before age 10
    • Evidence of familial hypercholesterolemia in at least one parent

Prescriber Requirements

Juxtapid must be prescribed by a specialist certified in the FDA REMS program:

  • Cardiologist
  • Endocrinologist
  • Lipid specialist

The prescriber must complete Juxtapid REMS certification including online training and enrollment before prescribing.

Step Therapy and Exceptions

UnitedHealthcare requires documented failure, intolerance, or contraindication to both:

  1. Repatha (evolocumab) - PCSK9 inhibitor
  2. Evkeeza (evinacumab) - ANGPTL3 inhibitor

Medical Exception Pathways

You can bypass step therapy if you document:

  • Contraindications: Allergic reactions, drug interactions
  • Prior failures: Inadequate LDL reduction after appropriate trial periods
  • Intolerance: Side effects preventing continued use
  • Already established: Currently taking Juxtapid with good response
Important: Juxtapid cannot be combined with PCSK9 inhibitors or Evkeeza due to safety concerns.

Required Diagnostics and Documentation

Essential Lab Values

  • Baseline liver function tests: ALT, AST, total bilirubin
  • Lipid panel: Total cholesterol, LDL-C, HDL-C, triglycerides
  • Genetic testing results (if using genetic criteria)

Clinical Documentation

Submit comprehensive medical records including:

  • HoFH diagnosis confirmation
  • Prior therapy trials and outcomes
  • Current lipid-lowering medications
  • Low-fat diet counseling documentation
  • Baseline and monitoring lab plans

REMS Program Requirements

Juxtapid is only available through the FDA-mandated REMS program due to hepatotoxicity risk. This requires:

For Prescribers

For Patients

  • Receive counseling on hepatotoxicity risks
  • Agree to liver function test monitoring schedule
  • Understand dietary restrictions and drug interactions

Monitoring Schedule

  • Monthly LFTs for the first year
  • Quarterly LFTs thereafter
  • More frequent monitoring if abnormalities occur

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans OptumRx PA forms UHC Policy
HoFH Diagnosis Genetic or clinical criteria Test results or LDL-C >400 mg/dL UHC Policy
Step Therapy Repatha AND Evkeeza failure Trial documentation UHC Policy
REMS Compliance Certified prescriber required REMS enrollment proof FDA REMS
Baseline Labs LFTs before starting ALT, AST, bilirubin results UHC Policy
Appeal Deadline 180 days from denial Written appeal submission WA Insurance Commissioner

Fastest Path to Approval

Step 1: Confirm HoFH Diagnosis (1-2 weeks)

Who: Patient with specialist Action: Schedule with REMS-certified cardiologist or lipid specialist Documents: Genetic test results or lipid panel showing LDL-C >400 mg/dL Timeline: Allow 1-2 weeks for genetic results if needed

Step 2: Document Step Therapy Failures (Same visit)

Who: Specialist reviews records Action: Gather documentation of Repatha and Evkeeza trials/contraindications Documents: Prior therapy records, allergy documentation, or contraindication notes Timeline: Can be completed during initial consultation

Step 3: Complete REMS Certification (1-3 days)

Who: Prescriber Action: Complete online REMS training if not already certified Documents: REMS certification completion Timeline: 1-3 business days for processing

Step 4: Submit Prior Authorization (Same day)

Who: Provider office Action: Submit via OptumRx provider portal Documents: PA form, medical necessity letter, REMS PAF, lab results Timeline: Submit same day as consultation

Step 5: Monitor for Decision (5-15 days)

Who: Patient and provider Action: Check portal daily for requests or decisions Timeline: Standard PA decisions within 15 days; expedited within 72 hours

Step 6: Appeal if Denied (Within 180 days)

Who: Patient or provider Action: Submit internal appeal with additional documentation Timeline: 180 days from denial date to file appeal

Step 7: External Review if Needed (Within 180 days of final denial)

Who: Patient Action: Request IRO review through Washington Insurance Commissioner Timeline: 30 days for IRO decision

Common Denial Reasons & Solutions

Denial Reason Solution Documents to Submit
HoFH not confirmed Submit genetic testing or clinical criteria Genetic results or LDL-C >400 mg/dL plus xanthoma/family history
Step therapy not met Document Repatha/Evkeeza failures Trial records, allergy notes, contraindication documentation
Non-certified prescriber Switch to REMS-certified specialist New prescription from certified cardiologist/endocrinologist
Missing baseline labs Submit required liver function tests ALT, AST, total bilirubin results
Drug interactions Review contraindicated medications Medication list review, alternative drug plans
From our advocates: We've seen many Juxtapid denials overturned when families work with their specialist to submit comprehensive genetic testing results alongside detailed documentation of prior PCSK9 inhibitor failures. The key is ensuring your lipid specialist understands both the REMS requirements and UnitedHealthcare's specific step therapy criteria before submitting the initial authorization.

Washington Appeals Process

Washington provides robust consumer protections for insurance denials, including external review by independent medical experts.

Internal Appeals (Commercial Plans)

  • Deadline: 180 days from denial
  • Timeline: 30 days for standard; 72 hours for expedited
  • How to file: UnitedHealthcare member portal or written request
  • Required: Medical records, specialist letters, peer-reviewed literature

External Review (After Internal Appeals)

Washington's Independent Review Organization (IRO) process provides binding decisions:

  • Deadline: 180 days from final internal denial
  • Timeline: 30 days for decision; 72 hours if expedited
  • How to file: Contact Washington Insurance Commissioner at 1-800-562-6900
  • Cost: Free to patients
  • Outcome: Binding on UnitedHealthcare

Medicaid Community Plan Appeals

Different process for UnitedHealthcare Community Plan members:

  • Step 1: UHC appeal within 60 days
  • Step 2: State administrative hearing within 120 days
  • Step 3: Independent review within 21 days of hearing decision

Cost Assistance Options

Manufacturer Support

Chiesi Global Rare Diseases offers patient assistance through:

  • Chiesi Total Care: Copay assistance and patient support services
  • Contact: Available through prescriber or Juxtapid website

Foundation Grants

Several organizations provide grants for rare disease medications:

  • Patient Access Network Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)
Tip: Apply for foundation grants early in your treatment journey, as funds are limited and awarded first-come, first-served.

When navigating insurance coverage challenges, platforms like Counterforce Health can help patients and clinicians turn denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

FAQ

How long does UnitedHealthcare prior authorization take in Washington? Standard decisions take up to 15 days; expedited requests (for urgent medical needs) are decided within 72 hours. Monitor your provider portal daily for information requests.

What if Juxtapid is not on my formulary? Non-formulary medications can still be covered through the medical exception process. Submit prior authorization with strong clinical justification and evidence of medical necessity.

Can I request expedited review? Yes, if your condition could seriously deteriorate without prompt treatment. Both prior authorization and appeals can be expedited in urgent situations.

Does step therapy apply if I tried these drugs in another state? Yes, UnitedHealthcare accepts prior therapy documentation from any provider, regardless of location. Ensure you have complete medical records showing trial periods and outcomes.

What happens if my appeal is denied? After exhausting internal appeals, you can request external review through Washington's IRO system. This provides an independent medical expert review with binding decisions.

How much does Juxtapid cost? Costs vary significantly by plan tier and coverage. Specialty medications like Juxtapid typically cost mid-five figures monthly without insurance. Check with your pharmacy benefits manager for specific copay information.

Can my family doctor prescribe Juxtapid? No, only REMS-certified specialists (cardiologists, endocrinologists, or lipid specialists) can prescribe Juxtapid due to FDA safety requirements.

What if I have drug interactions? Juxtapid is contraindicated with moderate or strong CYP3A4 inhibitors. Your specialist will review your medications and may need to adjust other drugs before starting Juxtapid.

This article is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific situation. For questions about Washington insurance regulations, contact the Office of the Insurance Commissioner at 1-800-562-6900.

Sources & Further Reading

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