By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (lomitapide) Covered by Humana in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Juxtapid (lomitapide) Covered by Humana in Washington

Fastest path to approval: Submit prior authorization through Humana's electronic PA portal with genetic confirmation of HoFH, documented failure of maximally tolerated standard lipid-lowering therapy, and baseline liver function tests. If denied, file internal appeal within 65 days, then request external review through Washington's Independent Review Organization (IRO) system.

First step today: Check your specific plan's formulary using Humana's Drug List tool and confirm Juxtapid's tier status and PA requirements.

Table of Contents

  1. Humana's Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity Limits and Renewal Criteria
  5. Required Diagnostics and Lab Values
  6. Specialty Pharmacy Network Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process in Washington
  10. Common Denial Reasons and Solutions

Policy Overview

Humana Medicare Advantage and commercial plans typically classify Juxtapid (lomitapide) as a specialty tier medication requiring prior authorization. The drug is processed through Humana Clinical Pharmacy Review (HCPR) for all coverage decisions.

Plan Types and Coverage Variations

  • Medicare Advantage: Standard PA timelines of 72 hours for routine requests
  • Commercial HMO/PPO: May have stricter step therapy requirements
  • Medicare Part D: Subject to formulary exception processes if non-formulary
Note: Prior authorization is not required for Humana Private Fee-for-Service (PFFS) plans, but notification is still requested.

Medical Necessity Requirements

FDA-Approved Indication

Juxtapid is FDA-approved as an adjunct to lipid-lowering therapies for homozygous familial hypercholesterolemia (HoFH) in adults. Humana's criteria typically require:

Diagnostic Documentation:

  • Confirmed HoFH diagnosis through genetic testing showing two pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1
  • OR clinical phenotype meeting HoFH criteria: untreated LDL-C ≥400-500 mg/dL with characteristic family history and physical findings

Age Requirements:

  • FDA labeling covers adults ≥18 years; some updated policies may allow younger patients per recent label expansions

Step Therapy and Exception Pathways

Required Prior Therapies

Before approving Juxtapid, Humana typically requires documentation of inadequate response or intolerance to:

  1. High-intensity statin at maximum tolerated dose
  2. Ezetimibe (unless contraindicated)
  3. PCSK9 inhibitor (evolocumab or alirocumab)
  4. Consider trial of evinacumab (Evkeeza) for HoFH if formulary-preferred

Medical Exception Criteria

Step therapy can be bypassed if you document:

  • Contraindications: Drug interactions (especially strong CYP3A4 inhibitors), liver disease, pregnancy
  • Prior intolerance: Documented adverse effects with specific symptoms and dates
  • Clinical urgency: Recent cardiovascular events, extremely high LDL-C levels

Quantity Limits and Renewal Criteria

Initial Authorization Limits

  • Quantity: Typically limited to FDA maximum daily dose (60 mg/day)
  • Duration: Initial approval often 6 months
  • Titration: Must follow FDA-labeled dose escalation schedule

Renewal Requirements

For continued coverage, document:

  • LDL-C response: Typically ≥30-40% reduction from baseline or achievement of treatment goals
  • Tolerability: No clinically significant liver injury (ALT/AST elevations)
  • Adherence: Consistent with prescribed regimen and monitoring requirements

Required Diagnostics and Lab Values

Baseline Requirements

Liver Function Tests (within 30 days of request):

  • ALT and AST
  • Total bilirubin
  • Alkaline phosphatase

Lipid Panel (fasting, within 3-6 months):

  • LDL-C levels (baseline and on current therapy)
  • Total cholesterol, HDL-C, triglycerides

Ongoing Monitoring Plan

Document commitment to FDA-required monitoring:

  • Monthly LFTs for first 12 months
  • After each dose increase
  • Every 3 months thereafter

Specialty Pharmacy Network Requirements

Humana typically requires Juxtapid to be dispensed through contracted specialty pharmacies. The drug is also subject to the Juxtapid REMS program, requiring:

  • Certified prescriber enrollment in REMS
  • REMS-certified pharmacy for dispensing
  • Patient acknowledgment of risks and monitoring requirements

Network Exception Requests

If the designated specialty pharmacy cannot serve your patient, request an exception documenting:

  • Geographic access barriers
  • Special handling or language service needs
  • Continuity of care concerns

Evidence to Support Medical Necessity

Clinical Guidelines

Reference these authoritative sources in your medical necessity letter:

  • FDA prescribing information for lomitapide
  • ACC/EAS guidelines on familial hypercholesterolemia management
  • European Atherosclerosis Society (EAS) 2023 consensus on HoFH treatment

Peer-Reviewed Evidence

Include citations supporting:

  • Efficacy of lomitapide in reducing LDL-C in HoFH patients
  • Safety profile with appropriate monitoring
  • Reduced cardiovascular events in severe hypercholesterolemia

Sample Medical Necessity Letter

Template Structure

Patient: [Name], DOB [date], Humana ID [number]
Diagnosis: Genetically confirmed homozygous familial hypercholesterolemia (ICD-10: E78.01)
Requested Medication: Juxtapid (lomitapide) 5mg capsules, #30, 30-day supply

Clinical Justification:

This 32-year-old patient has genetically confirmed HoFH with compound heterozygous mutations in LDLR [specific variants]. Despite maximally tolerated combination therapy including atorvastatin 80mg daily, ezetimibe 10mg daily, and evolocumab 140mg every two weeks, LDL-C remains markedly elevated at 285 mg/dL (baseline untreated: 520 mg/dL).

The patient has developed tendon xanthomas and has a strong family history of premature CAD. All formulary alternatives have been tried with either inadequate efficacy or intolerance [specify details]. Lomitapide represents the appropriate next step per ACC/EAS guidelines for refractory HoFH.

Baseline liver function tests are normal (ALT 28 U/L, AST 32 U/L), and I am committed to monthly monitoring per FDA requirements. I am REMS-certified for lomitapide prescribing.

Supporting Documentation: Genetic testing report, lipid trends, prior therapy documentation, baseline LFTs attached.

Appeals Process in Washington

Internal Appeals with Humana

Timeline: 65 days from denial notice
Method: Submit through Humana's exceptions and appeals portal
Required: Address each denial reason with additional clinical evidence

Washington External Review Process

If internal appeals fail, Washington residents can request Independent Review Organization (IRO) external review:

Filing Window: 180 days from final internal denial
Process: Submit request to your health plan, which forwards to Washington Office of Insurance Commissioner
Timeline: 30 days for standard review, 72 hours for expedited
Authority: RCW 48.43.535

Expedited Review Criteria

Request expedited review if delay would:

  • Seriously jeopardize life or health
  • Risk permanent impairment of bodily function
  • Cause severe pain that cannot be adequately managed

Washington Consumer Resources

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
"Not medically necessary" Emphasize HoFH severity, CV risk Genetic testing, lipid trends, family history
"Formulary alternatives available" Document specific failures/intolerances Detailed trial history with dates and outcomes
"Insufficient prior therapy" Show maximally tolerated standard care Prescription records, dose escalation attempts
"Missing genetic confirmation" Provide molecular diagnosis Laboratory report with pathogenic variants
"Inadequate monitoring plan" Detail LFT schedule and safety measures REMS certification, monitoring protocol
"Non-formulary drug" Request formulary exception Medical necessity letter per exception criteria

From Our Advocates

We've seen many Washington patients successfully overturn Juxtapid denials by focusing on the genetic confirmation and documenting specific reasons why each formulary alternative failed. The key is often providing detailed trial histories with exact dates and adverse effects, rather than general statements about "intolerance." Washington's external review process has been particularly effective for rare disease medications when the clinical evidence is strong.

Getting Expert Help

When insurance denials become complex, specialized support can make the difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements, including the clinical evidence and procedural details needed for successful appeals.

For Juxtapid appeals specifically, having expert assistance with medical necessity documentation and Counterforce Health's payer-specific workflows can significantly improve approval odds while reducing the administrative burden on your clinical team.

FAQ

Q: How long does Humana prior authorization take in Washington?
A: Standard PA decisions are made within 72 hours for Medicare plans. Commercial plans may have slightly different timelines but typically decide within 2-5 business days.

Q: What if Juxtapid is non-formulary on my plan?
A: You can request a formulary exception through Humana's standard process. You'll need strong medical justification showing why formulary alternatives are inappropriate.

Q: Can I request an expedited appeal if denied?
A: Yes, if you or your doctor believe waiting could seriously jeopardize your health. Both Humana internal appeals and Washington external reviews offer expedited tracks.

Q: Does step therapy apply if I tried medications outside Washington?
A: Yes, prior therapy documentation from any location is typically accepted. Ensure you have complete records with dates, doses, and outcomes.

Q: What's the success rate for external review in Washington?
A: While drug-specific statistics aren't published, Washington's IRO system is designed to provide independent medical review and has overturned many insurer denials when clinical evidence supports medical necessity.

Q: How much does Juxtapid cost without insurance?
A: Juxtapid is a high-cost specialty medication, typically in the mid-five figures annually. Check with Chiesi Total Care for patient assistance programs.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and review your specific insurance policy. For assistance with insurance appeals or questions about Washington's consumer protections, contact the Washington Office of Insurance Commissioner at 1-800-562-6900.

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