By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (Lomitapide) Covered by UnitedHealthcare in Michigan: Prior Authorization Guide and Appeal Scripts

Answer Box: Getting Juxtapid Covered by UnitedHealthcare in Michigan

UnitedHealthcare requires prior authorization for Juxtapid (lomitapide) with strict step therapy requirements. You must first fail or be unable to tolerate both Repatha (evolocumab) and Evkeeza (evinacumab) before approval. Your first step today: Have your cardiologist, endocrinologist, or lipid specialist submit genetic testing results confirming homozygous familial hypercholesterolemia (HoFH) along with documentation of failed prior therapies through UnitedHealthcare's provider portal. If denied, Michigan gives you 127 days to file an external appeal with DIFS—longer than most states.

Table of Contents

  1. UnitedHealthcare's Coverage Policy for Juxtapid
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. REMS Program and Monitoring Requirements
  5. Required Documentation Checklist
  6. Specialty Pharmacy Requirements
  7. Medical Necessity Letter Template
  8. Common Denial Reasons and Solutions
  9. Michigan Appeals Process
  10. Cost Assistance Programs
  11. FAQ

UnitedHealthcare's Coverage Policy for Juxtapid

UnitedHealthcare covers Juxtapid (lomitapide) as a specialty medication requiring prior authorization across all plan types—commercial, Medicare Advantage, and Medicaid managed care plans in Michigan. The drug requires approval through OptumRx, UnitedHealthcare's pharmacy benefit manager.

Key Policy Details:

  • Prior authorization required: Yes, for all strengths (5mg, 10mg, 20mg, 30mg, 40mg, 60mg capsules)
  • Formulary status: Specialty tier with quantity limits
  • Step therapy: Required (must fail Repatha and Evkeeza first)
  • Initial approval period: 12 months
  • Renewal requirements: Documentation of continued response and compliance
Note: Coverage terms can vary by specific plan. Always verify your individual benefits through the UnitedHealthcare member portal or by calling the number on your insurance card.

Medical Necessity Requirements

FDA-Approved Indication: Juxtapid is approved as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce LDL cholesterol in adults with homozygous familial hypercholesterolemia (HoFH).

UnitedHealthcare's Coverage Criteria:

Requirement Documentation Needed Source
HoFH Diagnosis Genetic testing showing bi-allelic mutations in LDLR, APOB, PCSK9, or LDLRAP1 genes OR Clinical criteria: LDL-C >400 mg/dL untreated with xanthomas before age 10 or family history UHC PA Form
Prescriber Must be prescribed by cardiologist, endocrinologist, or lipid specialist UHC Policy
Age 18 years or older FDA Label
Diet Compliance Patient on low-fat diet with nutritional supplements REMS Requirements
Baseline Therapy Currently receiving other lipid-lowering therapy (statin, ezetimibe, or LDL apheresis) UHC Criteria

Step Therapy and Exception Pathways

Required Prior Therapies: Before Juxtapid approval, patients must demonstrate failure, intolerance, or contraindication to:

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

Medical Exception Criteria:

  • Contraindication: Document specific medical reasons why the patient cannot use required step therapy drugs
  • Previous failure: Must show inadequate LDL-C reduction after appropriate trial duration
  • Intolerance: Document adverse effects that prevent continued use
Tip: Keep detailed records of all prior therapy attempts, including dates, dosages, duration, LDL-C levels before and after treatment, and specific reasons for discontinuation.

Exception Documentation Must Include:

  • Medication name, strength, and duration of trial
  • Pre- and post-treatment LDL-C levels
  • Specific adverse effects or contraindications
  • Clinical notes from prescribing physician

REMS Program and Monitoring Requirements

Juxtapid requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program due to hepatotoxicity risk. Both patient and prescriber must complete REMS certification before UnitedHealthcare will approve coverage.

Liver Function Monitoring Schedule:

Timeline Testing Frequency Required Tests
Before starting Baseline ALT, AST, alkaline phosphatase, total bilirubin
First year Monthly or before dose increases ALT, AST (minimum)
After first year Every 3 months and before dose increases ALT, AST, additional tests as needed

REMS Documentation for Insurance:

  • Signed Patient-Prescriber Acknowledgment Form
  • Baseline liver function tests within normal limits
  • Monitoring plan documentation
  • REMS-certified pharmacy enrollment
Important: Any ALT or AST ≥5x upper limit of normal requires immediate drug discontinuation and investigation. UnitedHealthcare may request ongoing lab results for coverage continuation.

Required Documentation Checklist

Before submitting your prior authorization request, gather these essential documents:

Clinical Documentation:

  • Genetic testing results confirming HoFH diagnosis
  • Current and historical LDL-C levels
  • Documentation of maximally tolerated statin therapy
  • Records of failed trials with Repatha and Evkeeza
  • Baseline liver function tests (within 30 days)
  • REMS enrollment confirmation
  • Specialist consultation notes

Insurance Information:

  • UnitedHealthcare member ID and group number
  • Current formulary tier for Juxtapid
  • Prior authorization form (completed by prescriber)
  • Any previous denial letters

Specialty Pharmacy Requirements

Juxtapid must be dispensed through a REMS-certified specialty pharmacy. UnitedHealthcare typically routes specialty medications through OptumRx specialty pharmacy network.

Approved Specialty Pharmacies:

  • OptumRx Specialty Pharmacy (UnitedHealthcare's preferred)
  • Limited network of REMS-certified retail specialty pharmacies

Important: Verify your specialty pharmacy is both UnitedHealthcare-contracted and REMS-certified before filling your prescription.

Medical Necessity Letter Template

Key Elements Your Doctor Should Include:

Patient Demographics & Diagnosis:

  • "Patient is an [age]-year-old [male/female] with genetically confirmed homozygous familial hypercholesterolemia (ICD-10: E78.01)"
  • "Genetic testing reveals [specific mutations] confirming HoFH diagnosis"

Treatment History:

  • "Patient has failed adequate trials of the following therapies: [list medications, doses, durations, and reasons for discontinuation]"
  • "Specifically tried and failed/could not tolerate Repatha (evolocumab) due to [reason] and Evkeeza (evinacumab) due to [reason]"

Current Clinical Status:

  • "Current LDL-C level is [X] mg/dL on maximally tolerated therapy"
  • "Patient is adherent to low-fat diet and receives appropriate nutritional supplementation"

Safety Monitoring:

  • "Baseline liver function tests are within normal limits (ALT: [X], AST: [X])"
  • "Patient and prescriber enrolled in Juxtapid REMS program"
  • "Comprehensive monitoring plan in place per REMS requirements"

Clinical Rationale:

  • "Juxtapid is medically necessary as patient has exhausted other HoFH treatment options"
  • "FDA-approved indication for HoFH with documented genetic confirmation"

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing genetic testing Submit HoFH genetic confirmation Lab report showing bi-allelic mutations
Inadequate step therapy Document failed trials of Repatha and Evkeeza Clinical notes with specific failure reasons
Missing REMS enrollment Complete REMS certification Signed acknowledgment forms
Baseline labs missing Submit current liver function tests Lab results within 30 days
Non-specialist prescriber Transfer care to required specialist Referral to cardiologist/endocrinologist
From our advocates: "We've seen many Juxtapid denials overturned simply by providing complete genetic testing documentation and detailed records of prior therapy failures. The key is demonstrating you've truly exhausted other options and have proper safety monitoring in place."

Michigan Appeals Process

If UnitedHealthcare denies your Juxtapid prior authorization, Michigan offers robust appeal rights under the Patient's Right to Independent Review Act.

Internal Appeals (First Step):

  1. Timeline: File within 180 days of denial
  2. How to file: Through UnitedHealthcare member portal or by mail
  3. Decision timeframe: Standard (30 days) or expedited (72 hours for urgent cases)

External Review (After Internal Appeal):

  1. Timeline: File within 127 days of final internal denial (longer than most states!)
  2. How to file: Michigan DIFS External Review Form
  3. Decision timeframe: 60 days standard, 72 hours expedited
  4. Cost: Free to patients
  5. Binding decision: UnitedHealthcare must comply if overturned

Contact Information:

  • DIFS Consumer Services: 877-999-6442
  • Online filing: Available through DIFS website
  • Expedited review: Requires physician letter stating health risk if delayed

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify the specific denial basis and draft point-by-point rebuttals aligned to UnitedHealthcare's own coverage rules, potentially saving months in the appeals process.

Cost Assistance Programs

Manufacturer Support:

  • Chiesi Patient Access Program: May provide copay assistance or free drug for eligible patients
  • Contact: Visit Juxtapid.com for current programs

Foundation Assistance:

  • Patient Advocate Foundation
  • National Organization for Rare Disorders (NORD)
  • HealthWell Foundation (when funds available)

State Programs:

FAQ

How long does UnitedHealthcare prior authorization take for Juxtapid in Michigan? Standard PA decisions are made within 72 hours for commercial plans and 14 days for Medicare Advantage. Urgent requests receive decisions within 24 hours.

What if Juxtapid isn't on my UnitedHealthcare formulary? Even non-formulary drugs can be covered with proper medical necessity documentation. Your doctor can request a formulary exception along with the PA.

Can I request an expedited appeal if my Juxtapid is denied? Yes, if your physician documents that a delay would seriously jeopardize your health. Both UnitedHealthcare internal appeals and Michigan external reviews offer expedited options.

Does step therapy apply if I failed these drugs with a different insurer? UnitedHealthcare typically accepts documented failures from other insurers, but you'll need complete medical records showing the previous trials and outcomes.

What happens if I move from Michigan to another state? Appeal rights and timelines vary by state. Your UnitedHealthcare coverage terms generally remain the same, but external review processes differ.

Sources & Further Reading

For additional support with complex insurance appeals, Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies may change, and individual plan terms may vary.

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