By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (odevixibat) Covered by Humana in New Jersey: Complete Prior Authorization & Appeals Guide

Quick Answer: Getting Bylvay (odevixibat) Covered by Humana in New Jersey

Bylvay (odevixibat) requires prior authorization from Humana and must be filled through specialty pharmacy. Your fastest path to approval: (1) Confirm your diagnosis meets FDA criteria (PFIC ≥3 months or Alagille syndrome ≥12 months), (2) Submit Humana's Medicare Prescription Drug Coverage Determination Request form with genetic testing results and failed therapy documentation to 1-877-486-2621, and (3) Follow up within 7 days. If denied, you have 65 days to appeal internally and can pursue New Jersey's IHCAP external review within 4 months of final denial.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather What You Need
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Typical Timelines in New Jersey
  7. If You're Asked for More Information
  8. If You're Denied: Appeals Process
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. FAQ

What This Guide Covers

This guide helps patients with Progressive Familial Intrahepatic Cholestasis (PFIC) or Alagille syndrome—and their healthcare teams—navigate Humana's prior authorization process for Bylvay (odevixibat) in New Jersey.

Bylvay is a specialty medication that costs between $14,152–$44,562 per month, with annual costs potentially reaching $106,000. Because of this high cost, Humana requires extensive documentation before approving coverage. However, with the right preparation, most medically appropriate requests are approved.

Who this helps:

  • Patients with confirmed PFIC or Alagille syndrome diagnoses
  • Parents and caregivers managing pediatric cases
  • Healthcare providers submitting prior authorizations
  • Anyone facing a Bylvay denial from Humana

Before You Start: Verify Your Coverage

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before first fill Humana PA search tool Humana Provider Portal
Formulary Tier Tier 4/5 specialty drug Humana drug lists Humana Formulary
Specialty Pharmacy Must use in-network specialty pharmacy Contact Humana member services Plan documents
Age Requirements ≥3 months (PFIC), ≥12 months (Alagille) FDA prescribing information FDA Label

Plan Type Verification

If you have Humana Medicare Advantage: Your appeals follow both Medicare and New Jersey state rules, giving you additional protection through New Jersey's IHCAP program.

If you have commercial Humana: You're covered under New Jersey's comprehensive external review process after completing internal appeals.

Tip: Call the number on your insurance card to confirm your specific plan type and verify that Bylvay requires prior authorization under your current formulary.

Gather What You Need

Essential Documentation Checklist

Medical Records:

  • Genetic testing results confirming PFIC or Alagille syndrome diagnosis
  • ICD-10 codes: Q44.7 (PFIC/Alagille syndrome) or K74.4 (secondary biliary cirrhosis)
  • Baseline liver function tests and fat-soluble vitamin levels
  • Documentation of moderate to severe pruritus
  • Serum bile acid levels (above normal range)

Prior Therapy Documentation:

  • Trial and failure/intolerance of ursodeoxycholic acid (Ursodiol)
  • At least one additional pruritus treatment attempted:
    • Bile acid sequestrants (cholestyramine)
    • Rifampin
    • Antihistamines
    • Naltrexone (for Alagille syndrome)
    • Sertraline (for Alagille syndrome)

Specialist Requirements:

  • Prescription from or consultation with hepatologist or gastroenterologist
  • Specialist attestation letter explaining medical necessity

Weight-Based Dosing (Pediatric Patients):

  • Current weight documentation
  • Dosing calculation: Starting dose 40 mcg/kg once daily
  • Justification if requesting dose escalation (up to 120 mcg/kg daily, max 6 mg)

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Download the Correct Form

2. Prepare Your Clinical Package Include a comprehensive medical necessity letter addressing:

  • Confirmed genetic diagnosis
  • Severity of pruritus and impact on quality of life
  • Failed conventional therapies with dates and reasons for discontinuation
  • Specialist recommendation and monitoring plan
  • Weight-based dosing rationale for pediatric patients

3. Submit via Fax

  • Fax number: 1-877-486-2621 (for Medicare requests)
  • Include: Completed PA form, medical necessity letter, genetic testing, lab results, prior therapy documentation
  • Confirmation: Request fax confirmation receipt

4. Specialty Pharmacy Coordination Ensure your prescription will be filled through Humana's designated specialty pharmacy network. Your prescriber should coordinate this routing to avoid delays.

Note: Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed submissions that align with each payer's specific requirements. Their platform can help ensure your initial request includes all necessary documentation to avoid common denial reasons.

Follow-Up and Tracking

When and How to Follow Up

Timeline for Follow-Up:

  • Day 3: Call to confirm receipt of fax
  • Day 7: Check status if no response received
  • Day 14: Escalate if still pending

What to Ask:

  • "Can you confirm receipt of the prior authorization request for Bylvay submitted on [date]?"
  • "What is the reference number for tracking?"
  • "What is the expected decision timeline?"
  • "Are any additional documents needed?"

Contact Numbers:

  • Provider line: 1-866-488-5995
  • Member services: Number on your insurance card

Sample Call Script: "Hi, I'm calling to check on a prior authorization request for Bylvay (odevixibat) for patient [name], member ID [number], submitted on [date]. Can you provide the status and reference number for tracking?"

Typical Timelines in New Jersey

Standard Processing Times

Appeal Level Humana Timeline New Jersey Rights Decision Method
Initial PA 7 days (Part D) State oversight applies Internal review
Expedited PA 72 hours Available for urgent cases Internal review
Internal Appeal 7 days (Part D) 65 days to file Internal review
External Review (IHCAP) 45 days 4 months to file Independent reviewer
Expedited External 48 hours - 5 days Available for urgent cases Independent reviewer

What Speeds Decisions:

  • Complete documentation submitted upfront
  • Clear specialist attestation
  • Genetic testing results included
  • Failed therapy timeline well-documented

What Slows Decisions:

  • Missing genetic confirmation
  • Incomplete prior therapy documentation
  • Non-specialist prescriber without consultation notes
  • Dosing that exceeds FDA-approved ranges without justification

If You're Asked for More Information

Common Information Requests

Medical Necessity Questions:

  • Provide additional clinical notes documenting pruritus severity
  • Include quality of life impact assessments
  • Submit recent liver function test results

Prior Therapy Clarification:

  • Detailed timeline of medications tried
  • Specific reasons for discontinuation (side effects, lack of efficacy)
  • Documentation of contraindications if applicable

Dosing Justification (Pediatric):

  • Current weight and growth charts
  • Rationale for dose escalation beyond 40 mcg/kg
  • Monitoring plan for higher doses
Tip: When submitting additional information, reference your original PA request number and restate the key medical necessity points to keep your case context clear.

If You're Denied: Appeals Process

Common Denial Reasons & Solutions

Denial Reason How to Address Required Documentation
"Not FDA-approved indication" Confirm diagnosis meets FDA criteria Genetic testing, specialist confirmation
"Insufficient prior therapy" Document all failed treatments Pharmacy records, clinic notes with dates
"Age below threshold" Verify patient meets minimum age Birth certificate, current medical records
"Non-formulary" Request formulary exception Medical necessity letter, no alternatives

Internal Appeals Process

Filing Deadline: 65 days from denial notice

Required Elements:

  • Written appeal letter explaining why coverage should be approved
  • All original documentation plus any new supporting evidence
  • Specific response to Humana's denial reasons

Submit to: Same fax number (1-877-486-2621) with "APPEAL" clearly marked

New Jersey External Review (IHCAP)

If Humana's internal appeal is denied, New Jersey residents have additional rights through the Independent Health Care Appeals Program.

Key Details:

  • Administrator: Maximus Federal Services (contracted by NJ DOBI)
  • Filing deadline: 4 months after final internal denial
  • Cost: Free to patients
  • Decision authority: Independent medical reviewers can overturn Humana's denial

How to File:

  1. Complete NJ IHCAP application
  2. Include all denial letters and medical records
  3. Submit directly to Maximus per instructions
  4. Request expedited review if medically urgent

Contact for Help:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467

The platform offered by Counterforce Health can be particularly valuable at this stage, as it analyzes denial letters and creates point-by-point rebuttals that align with New Jersey's external review standards and medical necessity criteria.

Renewal and Re-Authorization

When to Start Renewal Process

Timeline: Begin renewal process 30-60 days before current authorization expires

Required Documentation for Renewal:

  • Updated clinical response assessment
  • Current liver function tests
  • Documentation of continued pruritus or disease progression
  • Any dose adjustments and rationale
  • Specialist's continued recommendation

Evidence of Clinical Benefit:

  • Improvement in pruritus scores
  • Reduced serum bile acids
  • Better quality of life measures
  • Growth improvement (pediatric patients)
From our advocates: "We've seen that proactive renewal submissions with clear documentation of clinical benefit have much higher approval rates than last-minute requests. Start gathering updated lab results and clinical notes at least 6 weeks before your authorization expires."

Quick Reference Checklist

Before Submitting PA Request:

  • Confirm genetic diagnosis with lab report
  • Document failed conventional therapies
  • Obtain specialist consultation/prescription
  • Calculate appropriate weight-based dosing
  • Verify specialty pharmacy routing

During Review Process:

  • Follow up within 3-7 days of submission
  • Document all reference numbers and contact dates
  • Respond promptly to requests for additional information
  • Consider expedited review if medically urgent

If Denied:

  • File internal appeal within 65 days
  • Address specific denial reasons in appeal letter
  • Consider peer-to-peer review request
  • File IHCAP external review within 4 months if needed

FAQ

Q: How long does Humana take to approve Bylvay prior authorization in New Jersey? A: Standard timeline is 7 days for Part D prescription drug requests. Expedited reviews are completed within 72 hours if medically urgent.

Q: What if Bylvay is non-formulary on my Humana plan? A: You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate for your condition.

Q: Can I request an expedited appeal if my child's condition is worsening? A: Yes, both Humana internal appeals and New Jersey IHCAP external reviews offer expedited processing for urgent medical situations.

Q: Does step therapy apply if I tried treatments outside of New Jersey? A: Prior therapy documentation from any location is typically accepted as long as it's properly documented by licensed healthcare providers.

Q: What happens if I start Bylvay before getting prior authorization? A: You may be responsible for the full cost ($14,000+ per month). Always wait for approval unless it's a true medical emergency.

Q: Can my doctor request a peer-to-peer review with Humana? A: Yes, prescribers can request to speak directly with Humana's medical director to discuss the case. This often helps resolve complex denials.

Q: Are there financial assistance programs for Bylvay? A: Ipsen (the manufacturer) offers patient assistance programs. Check their website or speak with your specialty pharmacy about available support.

Q: What if Humana approves a lower dose than prescribed? A: You can appeal the quantity limitation by providing clinical justification for the higher dose, including weight-based calculations and specialist recommendations.

Disclaimer

This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance representative. Coverage policies and procedures may change. Always verify current requirements with Humana and consult official New Jersey Department of Banking and Insurance resources for the most up-to-date appeals information.

For personalized assistance with prior authorization submissions and appeals, consider consulting with healthcare advocacy services that specialize in insurance coverage for rare disease medications.

Sources & Further Reading:

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