By Counterforce Health Team in Juxtapid (lomitapide) —

How to Get Juxtapid (Lomitapide) Covered by Florida Blue Cross Blue Shield: PA Forms, Appeals & Success Tips

Answer Box: Getting Juxtapid Covered by Florida Blue

Juxtapid (lomitapide) requires prior authorization from Florida Blue and is typically placed on Tier 6 (Non-Preferred Specialty). To get approval: 1) Your doctor must submit genetic testing confirming homozygous familial hypercholesterolemia (HoFH) with bi-allelic pathogenic variants, 2) Document failed trials of PCSK9 inhibitors like Repatha, and 3) Use Florida Blue's specialty pharmacy network (CVS/Caremark or Accredo). If denied, you have 180 days to appeal internally, then 4 months for external review. Start by contacting Florida Blue at 1-877-719-2583 for the current PA form.

Table of Contents

Florida Blue Plan Types & Coverage Implications

Florida Blue offers several plan types that affect how Juxtapid coverage works:

Commercial Plans (HMO, PPO, EPO):

  • HMO plans may require referrals to specialists for genetic testing and HoFH management
  • PPO and EPO plans typically allow direct access to cardiologists and lipid specialists
  • All plans require prior authorization for specialty medications like Juxtapid

Medicare Advantage:

  • Subject to additional step therapy requirements for higher-cost Part B medications
  • Medical necessity definitions are stricter under Medicare guidelines
  • May have different specialty pharmacy networks than commercial plans
Note: Your specific plan documents override general policies. Always verify requirements through your member portal or by calling the customer service number on your insurance card.

Juxtapid Formulary Status & Tier Placement

Current Formulary Status (2024):

  • Tier 6 (Non-Preferred Specialty) - the highest specialty tier
  • Prior Authorization Required - no exceptions
  • Quantity Limits Apply - typically aligned with FDA-approved dosing
  • Limited Distribution - specialty pharmacy network only

Alternative Agents Florida Blue May Prefer:

  • Repatha (evolocumab) - PCSK9 inhibitor, lower tier placement
  • Evkeeza (evinacumab) - newer HoFH treatment, similar tier
  • LDL apheresis - covered as medical benefit in select cases

The tier placement means you'll pay the highest specialty copayment or coinsurance percentage. For most Florida Blue commercial plans, this ranges from $150-500+ per month depending on your specific benefit design.

Prior Authorization Requirements & Documentation

Genetic Testing Documentation Required

Florida Blue typically requires genetic confirmation of bi-allelic pathogenic/likely pathogenic variants in one of these genes:

  • Low-density lipoprotein receptor (LDLR)
  • Apolipoprotein B (APOB)
  • Proprotein convertase subtilisin kexin type 9 (PCSK9)
  • Low-density lipoprotein receptor adaptor protein 1 (LDLRAP1)

Alternative Clinical Criteria

If genetic testing is unavailable, clinical diagnosis requires both:

  • Untreated LDL-C greater than 400 mg/dL
  • Plus xanthoma before age 10 OR evidence of familial hypercholesterolemia in at least one parent

Additional Requirements

  • Specialist prescription (cardiologist, endocrinologist, or lipid specialist)
  • Low-fat diet compliance documentation
  • Concurrent lipid-lowering therapy (statins, ezetimibe, or LDL apheresis)
  • Prior failure or contraindication to PCSK9 inhibitors
Tip: Contact Florida Blue at 1-877-719-2583 to request the current Juxtapid prior authorization form, as requirements may be updated periodically.

Specialty Pharmacy Network Requirements

REMS Program Compliance: Juxtapid is subject to FDA Risk Evaluation and Mitigation Strategy (REMS) requirements due to liver toxicity risks. This means:

  • Only certified prescribers can order Juxtapid
  • Only certified specialty pharmacies can dispense it
  • Patients must complete enrollment and consent forms

Florida Blue Specialty Pharmacy Partners:

  • CVS/Caremark Specialty Pharmacy
  • Accredo Specialty Pharmacy

Important Restrictions:

  • No mail-order coverage through regular pharmacy benefits
  • No coverage at retail pharmacies - even if they're in-network for other medications
  • Prescriptions cannot be transferred between pharmacies without a new prescription

REMS Enrollment Steps

  1. Prescriber enrolls in Juxtapid REMS program
  2. Patient completes enrollment and informed consent
  3. Specialty pharmacy verifies all REMS requirements before dispensing
  4. Baseline liver function tests must be documented

Cost-Share Dynamics & Financial Considerations

Typical Florida Blue Specialty Cost-Sharing:

  • Tier 6 copayment: $150-500+ per month (plan-dependent)
  • Coinsurance plans: 30-50% of drug cost after deductible
  • Deductible: May apply before copayment kicks in

Manufacturer Support Options:

  • Chiesi Patient Assistance Program - income-based eligibility
  • Commercial insurance copay assistance - may reduce out-of-pocket costs
  • Foundation grants - available for qualifying rare disease patients
Note: This information is educational only. Consult your specific plan documents or benefits summary for exact cost-sharing amounts.

Step-by-Step: Fastest Path to Approval

Step 1: Confirm HoFH Diagnosis (Patient + Clinician)

Who: Cardiologist, endocrinologist, or lipid specialist
What: Genetic testing or clinical criteria documentation
Timeline: 2-4 weeks for genetic testing results
Submit to: Keep results for PA submission

Step 2: Document Failed Prior Therapies (Clinician)

Who: Prescribing physician
What: Records of Repatha/evolocumab trial and failure or contraindication
Timeline: Compile existing records
Submit to: Include in PA packet

Step 3: Complete REMS Enrollment (Patient + Clinician)

Who: Both patient and prescriber
What: Juxtapid REMS program enrollment and certification
Timeline: 1-2 weeks
Submit to: REMS program directly

Step 4: Submit Prior Authorization (Clinician)

Who: Prescriber or clinic staff
What: Complete PA form with all supporting documentation
How: Florida Blue provider portal or fax
Timeline: Submit before writing prescription

Step 5: Monitor PA Decision (Patient + Clinician)

Who: Clinic staff should track
What: Approval, denial, or request for additional information
Timeline: 15 business days for standard review
Next step: If approved, send prescription to specialty pharmacy

Step 6: Coordinate Specialty Pharmacy (Patient)

Who: Patient with specialty pharmacy support
What: Verify insurance coverage and coordinate first fill
Timeline: 3-5 business days after PA approval
Contact: CVS/Caremark Specialty or Accredo directly

Step 7: Maintain Ongoing Requirements (Patient + Clinician)

Who: Both patient and prescriber
What: Regular liver monitoring, annual PA renewal
Timeline: Ongoing per REMS requirements
Submit to: Keep records for reauthorization

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genetic testing Submit genetic analysis Bi-allelic pathogenic variants report
Inadequate prior trials Document PCSK9 inhibitor failure Treatment records showing inadequate response
REMS non-compliance Complete enrollment REMS certification for prescriber and patient
Wrong specialty pharmacy Resubmit to correct pharmacy New prescription to CVS/Caremark or Accredo
Incomplete clinical criteria Provide full HoFH documentation LDL-C levels, family history, physical findings
Missing liver monitoring plan Submit monitoring protocol Baseline and ongoing LFT schedule

Appeals Process Timeline & External Review

Internal Appeal (First Level)

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for future treatments, 60 days for rendered services
  • How to file: Florida Blue member portal or written request
  • Required: Copy of denial letter, medical records, prescriber letter

External Review (Independent Review)

  • When available: After final internal denial for medical necessity disputes
  • Deadline: 4 months after final adverse determination
  • Timeline: 45 days for standard review, 72 hours for urgent cases
  • Cost: Free to member
  • Success rate: External reviews overturn 30-50% of insurer denials nationally

Expedited Appeals

  • Criteria: Delay would seriously jeopardize life or health
  • Timeline: 72 hours for both internal and external review
  • Required: Physician certification of urgency
Important: Keep detailed records of all communications, including dates, names, and reference numbers.

Clinician Corner: Medical Necessity Letter

When writing a medical necessity letter for Juxtapid, include these key elements:

Patient-Specific Clinical Information:

  • Confirmed HoFH diagnosis with genetic testing results
  • Current LDL-C levels despite maximum tolerated therapy
  • Documentation of cardiovascular risk factors
  • Prior therapy trials and outcomes (especially PCSK9 inhibitors)

Evidence-Based Medical Rationale:

  • FDA approval for HoFH treatment
  • Clinical trial data supporting efficacy
  • Professional guideline recommendations (AHA/ACC, ESC/EAS)
  • Explanation of why alternative therapies are inadequate

Treatment Plan and Monitoring:

  • Proposed dosing regimen
  • Liver function monitoring protocol
  • Expected clinical outcomes and timeline
  • Plan for ongoing assessment

From Our Advocates: In our experience helping patients navigate specialty drug appeals, the strongest approvals include comprehensive genetic testing reports, detailed documentation of prior therapy failures with specific LDL-C responses, and a clear monitoring plan that addresses REMS requirements. These elements together demonstrate both medical necessity and safe prescribing practices.

FAQ: Most Common Questions

How long does Florida Blue prior authorization take? Standard PA reviews take up to 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Juxtapid is non-formulary on my plan? Juxtapid is typically covered as a Tier 6 specialty medication. If it's not on your formulary, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Your physician must certify the urgency in writing.

Does step therapy apply if I've tried therapies outside Florida? Yes, documented trials from other states or providers count toward step therapy requirements. Include complete medical records.

What happens if my appeal is denied? You can request external review by an independent medical expert within 4 months of the final denial.

Are there patient assistance programs for Juxtapid? Yes, Chiesi offers patient assistance programs and copay support for eligible patients. Contact them directly for applications.

Can I use any specialty pharmacy? No, you must use Florida Blue's contracted specialty pharmacies (CVS/Caremark or Accredo) for coverage.

How often do I need prior authorization renewal? Typically annually, but some plans may require more frequent reauthorization. Check your approval letter for specific terms.

When to Escalate to State Regulators

Contact Florida's Division of Consumer Services if:

  • Florida Blue doesn't follow proper appeal procedures
  • You experience unreasonable delays in processing
  • You need help understanding your appeal rights

Florida Insurance Consumer Helpline: 1-877-693-5236
Online complaints: Florida Department of Financial Services

Required documentation for state complaints:

  • Insurance policy information
  • Denial letters and correspondence
  • Medical records supporting your case
  • Timeline of events and communications

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing targeted, evidence-backed strategies. Our platform analyzes denial letters and plan policies to identify the specific approval pathway for each case, saving time and improving outcomes for complex medications like Juxtapid.

For additional support navigating your Juxtapid appeal, Counterforce Health offers specialized expertise in rare disease medication approvals, helping ensure your documentation meets Florida Blue's specific requirements while addressing REMS compliance and specialty pharmacy coordination.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan terms. Always consult your healthcare provider for medical decisions and your insurance company for coverage determinations. Appeals processes and requirements may change; verify current procedures with official sources.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.