By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (lomitapide) Covered by Aetna (CVS Health) in Virginia: Prior Authorization Forms, Appeal Timeline & REMS Requirements

Quick Answer: Fastest Path to Approval

Getting Juxtapid (lomitapide) covered by Aetna (CVS Health) in Virginia requires three critical steps: 1) Confirm homozygous familial hypercholesterolemia (HoFH) diagnosis with genetic testing or clinical criteria, 2) Document failure of high-intensity statin + ezetimibe + PCSK9 inhibitor therapy with LDL-C still ≥100 mg/dL, and 3) Complete REMS enrollment and submit baseline liver function tests with your prior authorization. Most approvals take 30-45 days, but you can request expedited review within 24 hours for urgent cases. Start today by gathering your genetic test results and recent lipid panels.

Table of Contents

  1. Understanding Aetna's Coverage Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. REMS Program & Hepatotoxicity Monitoring
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in Virginia
  6. Costs & Patient Assistance Programs
  7. FAQ

Understanding Aetna's Coverage Requirements

Aetna (CVS Health) covers Juxtapid (lomitapide) exclusively for homozygous familial hypercholesterolemia (HoFH) under their Specialty Pharmacy Clinical Policy 2071-A. The medication requires strict prior authorization and functions essentially as step therapy—you must try and fail specific treatments first.

Coverage at a Glance

Requirement What it means Documentation needed Source
Diagnosis Confirmed HoFH only Genetic testing or clinical criteria Aetna Policy
Step Therapy High-intensity statin + ezetimibe + PCSK9 inhibitor Treatment records with dates, doses, LDL-C results Aetna Policy
LDL-C Threshold ≥100 mg/dL (or ≥70 mg/dL with ASCVD) on therapy Recent lipid panel Aetna Policy
REMS Enrollment Certified prescriber and patient enrollment REMS documentation FDA REMS
Liver Monitoring Baseline LFTs and monitoring plan Lab results and protocol FDA REMS

HoFH Diagnosis Requirements

Aetna accepts HoFH diagnosis confirmed by any one of these criteria:

  • Genetic confirmation: Two mutated alleles at LDLR, APOB, PCSK9, or LDLRAP1 genes
  • Clinical criteria: Xanthomas before age 10 + untreated LDL-C typically >500 mg/dL
  • Family history: Untreated LDL-C ≥190 mg/dL in both parents
Tip: If you have LDL-receptor negative mutations in both alleles, you may be exempt from the step therapy requirement since statins and PCSK9 inhibitors aren't expected to work effectively.

Step-by-Step: Fastest Path to Approval

1. Verify Your Aetna Coverage (1-2 days)

Who does it: Patient or clinic staff
Documents needed: Insurance card, member ID
How to submit: Call member services or check online portal
Timeline: Same day

Contact Aetna at the number on your insurance card to confirm:

  • Your plan covers specialty medications
  • Juxtapid is on your formulary (it should be with PA)
  • Your current pharmacy benefits

2. Complete REMS Enrollment (3-5 days)

Who does it: Prescriber and patient
Documents needed: REMS Prescription Authorization Form
How to submit: Online through Juxtapid REMS website
Timeline: 3-5 business days for certification

Your doctor must enroll in the Juxtapid REMS program and you must complete patient enrollment. This is mandatory—no exceptions.

3. Gather Clinical Documentation (1-3 days)

Who does it: Clinic staff
Documents needed: Genetic test results, lipid panels, treatment history
Timeline: 1-3 days depending on records availability

Collect:

  • HoFH confirmation (genetic report or clinical evidence)
  • Baseline LDL-C (untreated or minimally treated)
  • Current LDL-C on maximally tolerated therapy
  • Treatment history with dates, doses, and outcomes for:
    • High-intensity statin therapy
    • Ezetimibe
    • PCSK9 inhibitor (evolocumab/Repatha or alirocumab/Praluent)

4. Complete Baseline Safety Labs (1-2 days)

Who does it: Patient
Documents needed: Lab requisition
Timeline: 1-2 days for results

Obtain baseline liver function tests:

  • AST (SGOT)
  • ALT (SGPT)
  • Total bilirubin
  • Alkaline phosphatase

5. Submit Prior Authorization (Same day)

Who does it: Prescriber or clinic staff
Documents needed: PA form, clinical documentation, REMS confirmation
How to submit: Aetna provider portal or fax
Timeline: 30-45 days for standard review, 24 hours for expedited

Submit via Aetna's provider portal or fax with complete documentation package.

6. Follow Up and Track Status (Ongoing)

Who does it: Clinic staff or patient
Timeline: Check status after 5-7 business days

Contact Aetna to check PA status and provide additional information if requested.

REMS Program & Hepatotoxicity Monitoring

Juxtapid carries a boxed warning for hepatotoxicity and requires enrollment in the FDA-mandated REMS program. This isn't optional—it's a federal requirement.

REMS Requirements for Prior Authorization

Prescriber certification: Your doctor must complete online REMS training and certification through the Juxtapid REMS website.

Patient enrollment: You must complete patient REMS enrollment and education materials.

Prescription Authorization Form (PAF): Each prescription requires a completed REMS PAF documenting safe-use conditions.

Liver Monitoring Protocol

Your PA must include a detailed liver monitoring plan:

Baseline requirements:

  • Recent liver function tests (AST, ALT, bilirubin)
  • Confirmation of no active liver disease
  • Screen for drug interactions (especially strong CYP3A4 inhibitors)

Ongoing monitoring:

  • Follow FDA prescribing information for monitoring frequency
  • Document thresholds for dose adjustment or discontinuation
  • Include monitoring schedule in your PA submission
Note: Counterforce Health helps patients and clinicians navigate complex REMS requirements and compile the documentation needed for specialty drug approvals. Their platform can streamline the prior authorization process by ensuring all REMS and safety monitoring elements are properly documented. Learn more about their services.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing HoFH documentation Submit genetic test results or detailed clinical criteria Genetic report showing two FH mutations OR clinical evidence (early xanthomas, family history, extreme LDL-C)
Inadequate step therapy Document specific therapies tried with dates, doses, and LDL-C results Treatment records showing maximally tolerated statin + ezetimibe + PCSK9 inhibitor
Missing REMS enrollment Complete prescriber and patient REMS certification REMS enrollment confirmation and completed PAF
Insufficient liver monitoring Submit detailed monitoring protocol and baseline labs Recent LFT results and written monitoring plan per FDA labeling
LDL-C not high enough Provide recent lipid panel on current therapy Lab results showing LDL-C ≥100 mg/dL (or ≥70 mg/dL with ASCVD)

Medical Necessity Letter Checklist

When appealing a denial, your clinician should include:

  • Problem statement: Severe HoFH with inadequately controlled LDL-C despite maximal therapy
  • Prior treatments: Specific medications tried, doses, duration, and LDL-C response
  • Clinical rationale: Why Juxtapid is medically necessary for this patient
  • Guideline support: Reference to FDA labeling and clinical guidelines
  • Safety plan: Detailed liver monitoring and REMS compliance plan

Appeals Process in Virginia

If Aetna denies your Juxtapid prior authorization, Virginia provides strong consumer protections through the State Corporation Commission Bureau of Insurance.

Internal Appeals with Aetna

Timeline: File within 180 days of denial
Decision: 30-45 days for standard review, 72 hours for expedited
How to file: Aetna provider portal, member services, or written request

External Review in Virginia

If Aetna upholds the denial after internal appeal, you can request external review through Virginia's independent process.

Timeline to file: Within 120 days of final denial notice
Review timeline: Up to 10 days for IRO decision
Cost: Free to consumers
How to file: Submit Form 216-A to SCC Bureau of Insurance

Contact information:

  • Mail: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
  • Fax: (804) 371-9915
  • Email: [email protected]
  • Phone: (877) 310-6560

Expedited Appeals

For urgent medical situations, request expedited review at each level:

  • Internal expedited: 72 hours
  • External expedited: Promptly (timeline varies by urgency)

Include a statement from your doctor explaining why waiting could seriously jeopardize your health.

Costs & Patient Assistance Programs

Juxtapid is an expensive specialty medication, typically costing mid-five figures per month depending on dose and insurance coverage.

Manufacturer Support

Chiesi Patient Support Program

  • Copay assistance for eligible commercially insured patients
  • Patient assistance program for uninsured/underinsured
  • Contact: Chiesi Total Care

Additional Resources

  • HealthWell Foundation: May provide copay assistance for qualifying patients
  • Patient Advocate Foundation: Offers case management and financial assistance
  • Virginia Free Clinic Association: For uninsured patients needing clinical support
Important: Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Juxtapid. Their evidence-based approach has helped many patients access critical therapies by crafting targeted appeals that address specific payer requirements. Visit their website to learn how they can support your case.

Frequently Asked Questions

Q: How long does Aetna prior authorization take for Juxtapid in Virginia?
A: Standard PA decisions take 30-45 days. You can request expedited review for urgent cases, which typically receive decisions within 24 hours.

Q: What if Juxtapid isn't on my Aetna formulary?
A: Juxtapid should be covered under Aetna's specialty pharmacy benefit with prior authorization. If it appears non-formulary, request a formulary exception with medical necessity documentation.

Q: Can I appeal if I've tried similar therapies outside Virginia?
A: Yes, treatment history from other states counts toward step therapy requirements. Provide complete documentation of prior therapies regardless of where they were tried.

Q: Do I need to use a specific pharmacy for Juxtapid?
A: Yes, Juxtapid is only available through REMS-certified specialty pharmacies. Aetna typically directs patients to CVS Specialty Pharmacy or other approved specialty providers.

Q: What happens if my liver tests become abnormal on Juxtapid?
A: Your doctor will follow FDA prescribing information for dose adjustment or discontinuation. Aetna may require documentation of the monitoring plan and any dose changes.

Q: Can I get help with the appeals process in Virginia?
A: Yes, contact the Virginia Bureau of Insurance at (877) 310-6560 for guidance on external review. The Virginia Poverty Law Center also provides assistance for health insurance appeals.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and is not medical advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult your healthcare provider for medical decisions and verify current policy details with your insurer. For personalized assistance with prior authorizations and appeals, consider consulting with healthcare advocates or legal professionals specializing in insurance matters.

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