By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (Lomitapide) Covered by UnitedHealthcare in California: Appeals, REMS Requirements, and Step Therapy Overrides

Answer Box: Getting Juxtapid Covered by UnitedHealthcare in California

Eligibility: Juxtapid requires prior authorization from UnitedHealthcare for confirmed homozygous familial hypercholesterolemia (HoFH) with genetic testing or LDL-C ≥400 mg/dL, baseline liver function tests, and documented failure/intolerance of other lipid-lowering therapies.

Fastest path: Submit prior authorization with HoFH genetic testing results, baseline LFTs, REMS program enrollment, and documentation of failed statins/PCSK9 inhibitors. If denied, file internal appeal within 180 days, then California Independent Medical Review (IMR) with 68% success rate for specialty drug appeals.

First step today: Contact your prescribing specialist to confirm REMS certification and gather genetic testing results, then call UnitedHealthcare at the number on your insurance card to initiate prior authorization.

Table of Contents

  1. UnitedHealthcare's Policy Overview
  2. Indication Requirements for Juxtapid
  3. Step Therapy and Medical Exceptions
  4. REMS Program and Monitoring Requirements
  5. Required Diagnostics and Documentation
  6. Specialty Pharmacy and Site of Care
  7. Evidence to Support Medical Necessity
  8. Appeals Process in California
  9. Common Denial Reasons and Solutions
  10. Cost Assistance Options
  11. FAQ

UnitedHealthcare's Policy Overview

UnitedHealthcare requires prior authorization for Juxtapid (lomitapide) across all plan types—commercial HMO/PPO, Medicare Advantage, and Medicaid managed care plans in California. The drug is typically placed on specialty tiers with higher cost-sharing, and coverage decisions are managed through OptumRx, UnitedHealthcare's pharmacy benefit manager.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all plan types UnitedHealthcare Provider Portal
Formulary Tier Specialty tier 4-5 Member formulary document
Step Therapy Must try preferred agents first PA policy document
REMS Certification Prescriber and pharmacy must be certified Juxtapid REMS Program
Baseline LFTs Required before starting FDA prescribing information
Appeals Deadline 180 days from denial Member handbook

Indication Requirements for Juxtapid

Juxtapid is FDA-approved as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce LDL cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). UnitedHealthcare requires documentation of confirmed HoFH diagnosis through:

Genetic Testing Confirmation

  • Pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Genetic testing report must be submitted with prior authorization request

Clinical Criteria (if genetic testing unavailable)

  • Untreated LDL-C >500 mg/dL OR treated LDL-C ≥300 mg/dL
  • Presence of xanthomas before age 10
  • Family history of premature cardiovascular disease
Note: UnitedHealthcare does not cover Juxtapid for non-HoFH hypercholesterolemia or off-label uses.

Step Therapy and Medical Exceptions

UnitedHealthcare requires patients to try and fail or demonstrate contraindications to preferred therapies before approving Juxtapid:

Required Prior Therapies

  1. High-intensity statins (atorvastatin 40-80mg or rosuvastatin 20-40mg)
  2. Ezetimibe (cholesterol absorption inhibitor)
  3. PCSK9 inhibitors (evolocumab/Repatha or alirocumab/Praluent)

Medical Exception Pathways

  • Contraindication: Document specific medical reasons (e.g., statin-induced myopathy, liver disease)
  • Intolerance: Provide records of adverse effects requiring discontinuation
  • Inadequate response: LDL-C levels remain >100 mg/dL despite maximum tolerated doses

REMS Program and Monitoring Requirements

Juxtapid has a Risk Evaluation and Mitigation Strategy (REMS) program due to hepatotoxicity risk. Both prescribers and pharmacies must be certified before dispensing.

Prescriber Certification Steps

  1. Complete Prescriber Training Module
  2. Submit signed JUXTAPID REMS Program Prescriber Enrollment Form
  3. Complete JUXTAPID REMS Program Prescription Authorization Form for each patient

Liver Function Monitoring

  • Baseline: Complete liver function tests before starting treatment
  • Ongoing: Periodic monitoring per prescribing information
  • Documentation: Submit baseline LFT results with prior authorization
Tip: Include your REMS certification confirmation in the prior authorization submission to avoid delays.

Required Diagnostics and Documentation

For successful prior authorization approval, submit comprehensive documentation:

Essential Documents Checklist

  • HoFH genetic testing results or clinical criteria documentation
  • Baseline liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
  • Records of prior lipid-lowering therapy trials and outcomes
  • Current lipid panel showing LDL-C levels
  • ICD-10 code E78.01 (familial hypercholesterolemia)
  • REMS program enrollment confirmation
  • Specialist prescription (cardiologist, endocrinologist, or lipid specialist)

Timing Requirements

  • Lab values must be within 90 days of submission
  • Prior therapy trials should show adequate duration (typically 6-8 weeks at maximum tolerated dose)

Specialty Pharmacy and Site of Care

UnitedHealthcare typically requires Juxtapid to be dispensed through their preferred specialty pharmacy network:

Dispensing Requirements

  • Must use OptumRx specialty pharmacy or approved network pharmacy
  • REMS-certified pharmacy required
  • 30-day supply limits initially, with potential for 90-day fills after stable dosing

Administration

  • Oral medication taken at home
  • No infusion or injection site requirements
  • Patient must follow low-fat diet (<20% of calories from fat)

Supporting Evidence for Medical Necessity

When submitting appeals or peer-to-peer reviews, reference these evidence sources:

Clinical Guidelines

  • FDA prescribing information for lomitapide
  • American Heart Association/American College of Cardiology cholesterol guidelines
  • National Lipid Association recommendations for HoFH management

Key Studies

  • Phase 3 clinical trials demonstrating LDL-C reduction in HoFH patients
  • Real-world evidence of cardiovascular outcomes improvement
  • Safety data supporting risk-benefit profile with proper monitoring

Appeals Process in California

California offers robust appeal rights through a dual regulatory system. Most UnitedHealthcare plans fall under Department of Managed Health Care (DMHC) oversight.

Step-by-Step Appeals Process

  1. Internal Appeal (First Level)
    • Timeline: File within 180 days of denial
    • Response: UnitedHealthcare has 30 days to respond (72 hours for urgent cases)
    • Submit: Member/provider portal or written request
  2. Internal Appeal (Second Level, if available)
    • Timeline: 30 days from first-level denial
    • Response: 30 days for standard, 72 hours for urgent
  3. Independent Medical Review (IMR)
    • Eligibility: After exhausting internal appeals
    • Timeline: 45 days for decision (7 days for expedited)
    • Success Rate: 68% for specialty drug appeals against UnitedHealthcare
    • Cost: Free to patients
    • Submit: DMHC website or call 888-466-2219
California Advantage: IMR decisions are binding on insurers, and California has one of the highest appeal success rates in the nation.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Insufficient HoFH documentation Submit genetic testing results Pathogenic variant confirmation
Missing step therapy Document prior therapy failures Prescription records, lab results
Inadequate liver monitoring plan Include REMS compliance strategy Baseline LFTs, monitoring schedule
Non-formulary status Request formulary exception Medical necessity letter
Drug interactions Confirm no contraindicated meds Current medication list review

Sample Medical Necessity Language "Patient has genetically confirmed HoFH with pathogenic LDLR variant, baseline LDL-C of 450 mg/dL despite maximum statin therapy, documented intolerance to PCSK9 inhibitors (muscle pain requiring discontinuation), and established baseline liver function monitoring plan per REMS requirements."

Cost Assistance Options

Manufacturer Support

  • Chiesi Total Care patient assistance program
  • Copay assistance for commercially insured patients
  • Free drug program for uninsured patients meeting income criteria

Foundation Grants

  • National Organization for Rare Disorders (NORD)
  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)

FAQ

How long does UnitedHealthcare prior authorization take in California? Standard requests: 72 hours for commercial plans, 14 days for Medicare Advantage. Urgent requests: 24 hours. If no response within the timeline, the request is automatically approved.

What if Juxtapid isn't on my formulary? You can request a formulary exception with medical necessity documentation. If denied, this decision can be appealed through the same process as prior authorization denials.

Can I get expedited review for Juxtapid appeals? Yes, if your doctor certifies that delays could seriously jeopardize your health. Expedited appeals receive decisions within 72 hours internally and 7 days for IMR.

Does step therapy apply if I tried therapies outside California? Yes, UnitedHealthcare will accept documentation of prior therapy trials from any state, as long as records clearly show adequate trial duration and outcomes.

What happens if my prescriber isn't REMS-certified? The prescription cannot be filled until your prescriber completes REMS certification. This process typically takes 1-2 business days and can be completed online at Juxtapid REMS.

How often do I need reauthorization? UnitedHealthcare typically requires annual reauthorization for Juxtapid, with documentation of continued medical necessity and ongoing liver function monitoring.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer requirements. For complex cases like Juxtapid approvals, we help identify the exact documentation needed and draft point-by-point rebuttals aligned to UnitedHealthcare's own coverage rules, significantly improving approval rates for rare disease medications.

When facing a Juxtapid denial, Counterforce Health can help you gather the right clinical evidence—from FDA labeling to peer-reviewed studies—and weave them into appeals that meet California's procedural requirements while tracking deadlines and required attachments.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact UnitedHealthcare directly for the most current coverage policies. For assistance with appeals in California, contact the DMHC Help Center at 888-466-2219.

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