By Counterforce Health Team in Bylvay (odevixibat) —

Do You Qualify for Bylvay (odevixibat) Coverage by Blue Cross Blue Shield in Florida? Decision Tree & Next Steps

Answer Box: Quick Qualification Check

Florida Blue requires prior authorization for Bylvay (odevixibat) with strict criteria: age ≥3 months (PFIC) or ≥12 months (Alagille), genetic testing confirmation, documented moderate-to-severe pruritus, and failure of ursodeoxycholic acid plus one alternative (cholestyramine, rifampin, or antihistamine). Submit via Availity.com or call 1-877-719-2583. If denied, you have 180 days to appeal internally, then 4 months for external review through Florida DFS.

First step today: Gather genetic test results, liver function tests, and documentation of failed prior therapies—these are mandatory for approval.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Decision Tree
  3. If "Likely Eligible" - Document Checklist
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet Eligible" - Alternative Options
  6. If Denied - Appeals Path
  7. Florida Blue Coverage Requirements
  8. Common Denial Reasons & Solutions
  9. FAQ
  10. Sources & Further Reading

How to Use This Guide

This guide helps patients and families navigate Bylvay coverage with Florida Blue Cross Blue Shield. We'll walk through eligibility step-by-step, then provide specific action plans based on where you stand.

Before you start: Have your insurance card, recent lab results, and a list of medications you've tried for cholestatic pruritus ready.

Note: This information is current as of 2024 but policies can change. Always verify requirements with your specific Florida Blue plan.

Eligibility Decision Tree

Step 1: Diagnosis Confirmation

Do you have a confirmed diagnosis of PFIC or Alagille syndrome?

  • ✅ Yes, with genetic testing → Continue to Step 2
  • ⚠️ Yes, but no genetic testing → See "Possibly Eligible" section
  • ❌ No confirmed diagnosis → See "Not Yet Eligible" section

Step 2: Age Requirements

Are you the right age for your condition?

  • PFIC with pruritus: ≥3 months old
  • Alagille syndrome with pruritus: ≥12 months old
  • ✅ Yes → Continue to Step 3
  • ❌ No → Wait until age requirement met, discuss with specialist

Step 3: Specialist Involvement

Are you being treated by a pediatric hepatologist or gastroenterologist?

  • ✅ Yes → Continue to Step 4
  • ❌ No → Get specialist referral first

Step 4: Prior Therapy Documentation

Have you tried and failed (or can't tolerate) ursodeoxycholic acid AND at least one of the following?

  • Cholestyramine (Questran)
  • Rifampin
  • Antihistamines
  • ✅ Yes, with documented dates/doses/outcomes → "Likely Eligible"
  • ⚠️ Partial documentation → "Possibly Eligible"
  • ❌ No prior therapies documented → "Not Yet Eligible"

If "Likely Eligible" - Document Checklist

Required Documentation for Prior Authorization

Document Type Specific Requirements Where to Get It
Genetic Testing Confirmation of PFIC or Alagille syndrome mutations Hepatology clinic records
Liver Function Tests Baseline LFTs within past 3 months Lab reports from physician
Fat-Soluble Vitamins Levels of vitamins A, D, E, K Recent lab work
Prior Therapy Records Dates, doses, duration, reasons for failure/intolerance Pharmacy records + clinical notes
Pruritus Documentation Moderate-to-severe scratching/impact on daily life Physician assessment notes
Prescription From pediatric hepatologist/gastroenterologist Specialist office

Submission Path

  1. Primary Route: Availity.com portal (fastest)
  2. Phone: 1-877-719-2583 for PA status/questions
  3. Pharmacy Benefit: Prime Therapeutics at 800-424-947

Timeline: Standard review takes 72 hours to 15 days; expedited review available if urgent.

Tip: Submit all documents at once. Incomplete submissions delay approval and may result in automatic denial.

If "Possibly Eligible" - Tests to Request

Missing Genetic Testing

Request genetic panel for:

  • PFIC: Bile acid transporter variants (excluding PFIC2 with non-functional BSEP-3)
  • Alagille syndrome: JAG1/NOTCH2 mutations

Incomplete Prior Therapy Documentation

Work with your pharmacist and previous doctors to gather:

  • Exact start/stop dates for each medication
  • Dosages prescribed
  • Specific reasons for discontinuation (side effects, lack of efficacy)
  • Any emergency room visits or hospitalizations related to pruritus

Timeline to Re-apply

  • Genetic testing results: 2-4 weeks
  • Medical records requests: 1-2 weeks
  • Complete PA submission: Plan for 3-6 weeks total preparation time

If "Not Yet Eligible" - Alternative Options

Clinical Trial Participation

  • Contact Ipsen clinical trials for ongoing studies
  • May provide access while building documentation for future coverage

Bridge Therapy Options

Work with your hepatologist on:

  • Optimizing current anti-pruritus medications
  • Liver transplant evaluation if appropriate
  • Supportive care measures

Building Your Case for Exception

Florida Blue may approve exceptions with compelling medical necessity. Document:

  • Severity of symptoms affecting quality of life
  • All contraindications to standard therapies
  • Specialist recommendation with detailed rationale

If Denied - Appeals Path

Internal Appeal (First Level)

Deadline: 180 days from denial notice date

Required Documents:

  • Completed Florida Blue appeal form
  • Original denial letter
  • Letter of medical necessity from prescribing physician
  • All supporting clinical records
  • Evidence addressing specific denial reasons

Submission: Via Availity portal, fax, or address on denial letter

Timeline: 72 hours (expedited) or 15-30 days (standard)

Peer-to-Peer Review

Request within 72 hours via 1-877-719-2583. Prepare your specialist with:

  • FDA approval data for PFIC/Alagille syndrome
  • Published efficacy studies
  • Patient-specific factors supporting medical necessity

External Review (Florida DFS)

Eligibility: After internal appeal exhaustion Deadline: 4 months (120 days) from final internal denial Cost: Free to patient Contact: Florida Department of Financial Services at 1-877-693-5236 or myfloridacfo.com

Success rates: Well-documented appeals with strong medical evidence succeed in 70-78% of cases.

Florida Blue Coverage Requirements

Initial Authorization Criteria

All of the following must be met:

  1. Prior approval history OR previously met all indication-specific criteria
  2. Documented beneficial response (clinically meaningful reduction in pruritus)
  3. No liver transplant received
  4. Age requirements: ≥3 months (PFIC) or ≥12 months (Alagille)
  5. Specialist prescriber: Hepatologist or gastroenterologist
  6. Failed prior therapies: Ursodeoxycholic acid plus one alternative

Reauthorization Requirements

  • LFTs and fat-soluble vitamin levels within past 3 months
  • Pruritus improvement documentation OR dosing plan if no benefit
  • Duration: 12 months if criteria met
From our advocates: "We've seen families wait months for genetic testing results, only to have their PA denied for incomplete prior therapy documentation. Start gathering pharmacy records early—some pharmacies only keep records for 2-3 years, and you'll need detailed information about why each medication was stopped."

Common Denial Reasons & Solutions

Denial Reason How to Address Required Evidence
"Off-label use" Cite FDA approval for cholestatic pruritus in PFIC/ALGS FDA labeling, medical necessity letter
"Age below threshold" Verify patient age meets plan criteria Birth certificate, current medical records
"Lack of specialist" Get hepatology/GI consultation Specialist consultation notes
"Insufficient prior therapy" Document specific failed treatments with dates/doses Pharmacy records, physician notes
"Missing genetic testing" Submit genetic confirmation results Lab reports confirming PFIC/ALGS mutations
"Not medically necessary" Provide comprehensive clinical picture Pruritus severity, impact on daily life, specialist assessment

FAQ

How long does Florida Blue prior authorization take? Standard review: 72 hours to 15 days. Expedited review (if urgent): 24-72 hours. Submit via Availity.com for fastest processing.

What if Bylvay is non-formulary on my plan? Florida Blue typically requires prior authorization regardless of formulary status. The same medical necessity criteria apply, but you may face higher copays.

Can I request an expedited appeal if my child is suffering? Yes. If delay in treatment poses health risks, request expedited review through your physician. Decision required within 72 hours.

Does step therapy apply if we tried medications outside Florida? Yes, but you'll need detailed documentation from out-of-state providers showing specific medications, doses, duration, and reasons for discontinuation.

What's the difference between medical and pharmacy benefits? Bylvay is typically covered under medical benefits (not pharmacy). Submit PA through medical prior authorization, not your pharmacy benefit manager.

How much does Bylvay cost without insurance? $14,152–$44,562 per 30 capsules depending on strength, with annual costs potentially exceeding $100,000. Ipsen patient assistance may help with costs.

When facing insurance denials for complex rare disease treatments like Bylvay, having expert support can make the difference between approval and ongoing delays. 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 insurer's specific requirements.

For families navigating Bylvay coverage denials, Counterforce Health's platform pulls the right medical evidence—from FDA labeling to peer-reviewed studies—and weaves them into appeals that meet Florida Blue's procedural requirements while tracking deadlines and required documentation. This systematic approach helps clinicians save time with ready-to-use templates while giving patients clear next steps in plain language.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria can change. Always consult with your healthcare provider and verify current requirements with your specific Florida Blue plan. For assistance with insurance problems, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

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