By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (Lomitapide) Covered by Humana in North Carolina: Prior Authorization Guide & Appeal Process

Quick Answer: Juxtapid (Lomitapide) Coverage by Humana in North Carolina

Yes, Humana covers Juxtapid (lomitapide) in North Carolina with prior authorization for homozygous familial hypercholesterolemia (HoFH). Key requirements: genetic confirmation of HoFH, documented failure of statins/ezetimibe/PCSK9 inhibitors, REMS program enrollment, and specialist involvement (cardiologist/endocrinologist). First step today: Contact your prescribing specialist to initiate REMS enrollment and gather documentation of prior therapy failures. If denied, North Carolina's external review through Smart NC provides binding appeal rights within 120 days.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If You're Likely Eligible: Document Checklist
  4. If You're Possibly Eligible: Next Steps
  5. If You're Not Yet Eligible: Alternatives
  6. If Denied: Appeal Path Chooser
  7. Coverage Requirements at a Glance
  8. Appeals Playbook for North Carolina
  9. Common Denial Reasons & How to Fix Them
  10. FAQ

How to Use This Guide

This decision tree helps you determine your eligibility for Juxtapid (lomitapide) coverage through Humana and provides the fastest path to approval. Juxtapid is a specialty oral medication for homozygous familial hypercholesterolemia (HoFH) that requires strict prior authorization and REMS program enrollment due to hepatotoxicity risks.

Start here: Answer the eligibility questions below to determine your pathway. Each section includes specific documents needed, submission methods, and timelines based on Humana's current prior authorization criteria.

Eligibility Triage: Do You Qualify?

Step 1: Confirmed HoFH Diagnosis?

You need ONE of the following:

  • Genetic testing showing two pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Untreated LDL-C ≥400 mg/dL with one parent having clinically diagnosed FH
  • Untreated LDL-C >500 mg/dL or treated LDL-C ≥300 mg/dL plus childhood xanthomas (before age 10)

Step 2: Age and Specialist Requirements Met?

  • Age 18 or older (Humana requirement)
  • Prescribed by or consulted with cardiologist or endocrinologist

Step 3: Step Therapy Completed?

Required prior treatments (unless contraindicated):

  • Maximum tolerated statin therapy (atorvastatin, rosuvastatin)
  • Ezetimibe trial
  • PCSK9 inhibitor trial (alirocumab/Praluent or evolocumab/Repatha)

Step 4: REMS Program Ready?

  • Prescriber willing to enroll in Juxtapid REMS program
  • Patient able to comply with liver monitoring requirements
  • Access to certified specialty pharmacy for dispensing

If You're Likely Eligible: Document Checklist

Required Documentation for Prior Authorization

Clinical Documentation:

  • Genetic test results confirming HoFH OR clinical criteria documentation
  • Baseline liver function tests (ALT, AST, bilirubin)
  • Current lipid panel with LDL-C levels
  • Documentation of prior therapy trials and outcomes

REMS Requirements:

Specialist Requirements:

  • Prescription from cardiologist or endocrinologist
  • Medical necessity letter detailing HoFH diagnosis and treatment rationale

Submission Process

  1. Submit through Humana Provider Portal or fax prior authorization request
  2. Include all supporting documentation listed above
  3. Expect decision within 15 business days (standard) or 72 hours (expedited)
  4. Coordinate with certified specialty pharmacy for REMS compliance

If You're Possibly Eligible: Next Steps

Missing Documentation to Obtain

If genetic testing incomplete:

If step therapy incomplete:

  • Document trial and failure/intolerance of required medications
  • Obtain specialist consultation if not already involved
  • Consider evinacumab (Evkeeza) trial if required by plan

Timeline to reapply: 4-8 weeks after obtaining missing documentation

If You're Not Yet Eligible: Alternatives

Alternative HoFH Treatments to Discuss

Preferred by insurance plans before Juxtapid:

  • Evinacumab (Evkeeza): ANGPTL3 inhibitor, may be required before Juxtapid
  • LDL apheresis: If available at nearby centers
  • Combination therapy: Maximum statin + ezetimibe + PCSK9 inhibitor

Prepare for exception requests:

  • Document medical necessity for Juxtapid over alternatives
  • Obtain specialist letter supporting first-line use if clinically appropriate
  • Consider Counterforce Health's appeal assistance for complex cases
From our advocates: We've seen cases where patients with severe HoFH (LDL-C >600 mg/dL despite combination therapy) successfully obtained Juxtapid as first-line therapy by documenting the urgency of aggressive LDL reduction and potential delays with sequential step therapy. The key was a detailed specialist letter citing HoFH treatment guidelines and individual patient risk factors.

If Denied: Appeal Path Chooser

Level 1: Internal Appeal with Humana

Timeline: 65 days from denial notice Process: Submit redetermination request with additional clinical documentation Success factors: New clinical evidence, peer-to-peer review, corrected documentation

Level 2: Peer-to-Peer Review

When to request: Initial denial based on medical necessity Process: Prescriber speaks directly with Humana medical director Timeline: Typically scheduled within 1-2 business days

Level 3: External Review (North Carolina)

Timeline: 120 days from final internal denial Process: Smart NC external review through NC Department of Insurance Contact: 1-855-408-1212 Binding decision: 45 days for standard review, 72 hours for expedited

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all Humana plans PA request form, clinical notes Humana Policy
HoFH Diagnosis Genetic or clinical criteria Genetic test or lipid/clinical evidence FDA Labeling
Age Requirement 18+ years Date of birth verification Humana Policy
Specialist Requirement Cardiologist or endocrinologist Prescriber credentials Humana Policy
Step Therapy Statin, ezetimibe, PCSK9 inhibitor Prior therapy documentation Humana Policy
REMS Enrollment Mandatory for prescriber/patient REMS forms, monitoring plan FDA REMS

Appeals Playbook for North Carolina

Internal Appeals (Humana)

Standard Appeal:

  • Deadline: 65 days from denial
  • Submission: Humana member portal or mail
  • Timeline: 30 days for decision
  • Required: Redetermination request form, supporting documentation

Expedited Appeal:

  • When: Urgent medical need
  • Timeline: 72 hours for decision
  • Process: Same as standard but marked "expedited"

External Review (Smart NC)

Eligibility:

  • Final internal denial received
  • State-regulated plan (most individual/small group plans)
  • Medical necessity or experimental treatment denial

Process:

  1. Call Smart NC: 1-855-408-1212 for guidance
  2. Submit request: External review form within 120 days
  3. Provide documentation: Medical records, denial letters, clinical evidence
  4. IRO assignment: Independent review organization assigned
  5. Decision: 45 days standard, 72 hours expedited

Key advantage: Smart NC provides free advocacy and can help gather supporting documentation.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Genetic testing not provided" Submit comprehensive FH genetic panel Lab report showing pathogenic variants
"Step therapy not completed" Document prior therapy trials/failures Pharmacy records, physician attestation
"REMS not enrolled" Complete prescriber/patient REMS enrollment REMS confirmation forms
"Not prescribed by specialist" Obtain specialist consultation/prescription Cardiologist or endocrinologist involvement
"Baseline monitoring absent" Establish liver monitoring plan LFT results, monitoring schedule

FAQ

How long does Humana prior authorization take for Juxtapid in North Carolina? Standard decisions within 15 business days; expedited within 72 hours. REMS enrollment may add 1-2 weeks to the overall process.

What if Juxtapid is non-formulary on my Humana plan? Request a formulary exception with medical necessity documentation. North Carolina external review rights apply if denied.

Can I request an expedited appeal if my LDL-C is extremely high? Yes, if delay could seriously harm your health. Document cardiovascular risk and urgency of treatment initiation.

Does step therapy apply if I failed these medications outside North Carolina? Yes, prior therapy documentation from any state/provider is acceptable. Obtain records from previous prescribers.

What specialty pharmacies can dispense Juxtapid through Humana? Only REMS-certified specialty pharmacies. CenterWell Specialty Pharmacy is commonly used for Humana members.

How much does Juxtapid cost with Humana coverage? Costs vary by plan tier and coverage level. Chiesi Total Care offers copay assistance for eligible patients.

When navigating complex prior authorization requirements for specialty medications like Juxtapid, having expert guidance can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements. Their platform pulls the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with the required clinical facts and operational details that payers expect for buy-and-bill therapies.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Coverage criteria and appeal processes may change; verify current requirements with official sources.

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