By Counterforce Health Team in Bylvay (odevixibat) —

Bylvay (Odevixibat) Approval with Humana in New York: Complete Guide to Prior Authorization, Appeals, and Coverage Requirements

Answer Box: How to Get Bylvay (Odevixibat) Covered by Humana in New York

Bylvay (odevixibat) requires prior authorization from Humana for both PFIC and Alagille syndrome. Your hepatologist or gastroenterologist must submit documentation including genetic confirmation, pruritus severity, and prior treatment failures. Three steps to start today: (1) Confirm your diagnosis meets Humana's coverage criteria, (2) Have your specialist gather required documentation, and (3) Submit the PA request through Humana's provider portal or CenterWell Specialty Pharmacy. If denied, you have 65 days to appeal internally, then 4 months for New York's external review through DFS.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Medical Necessity Criteria
  5. Understanding Costs
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Process
  9. Common Issues and Solutions
  10. Frequently Asked Questions

Coverage Basics

Is Bylvay Covered by Humana?

Yes, Bylvay (odevixibat) is covered under Humana Medicare Advantage plans with prior authorization. The medication has an active coverage policy effective March 19, 2025, confirming ongoing formulary inclusion. Coverage applies to both Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille syndrome when specific criteria are met.

Which Humana Plans Cover Bylvay?

  • Medicare Advantage (Part C): Covered with prior authorization
  • Medicare Part D: Prescription drug coverage with PA requirements
  • Commercial plans: Coverage varies by specific plan design
Note: Medicare patients are not eligible for manufacturer copay assistance through IPSEN CARES due to federal regulations.

Prior Authorization Process

Who Submits the Prior Authorization?

Your hepatologist or gastroenterologist must submit the prior authorization request. Primary care physicians typically cannot approve specialty medications like Bylvay without specialist consultation.

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis (Patient/Family)
    • Obtain genetic testing results for PFIC or Alagille syndrome
    • Document pruritus severity and impact on daily life
    • Timeline: 1-2 weeks for genetic results if not already available
  2. Gather Treatment History (Clinic Staff)
    • Compile records of prior therapies tried and failed
    • Include ursodeoxycholic acid, antihistamines, rifampin, or other treatments
    • Document: Submit via Humana provider portal
  3. Submit Prior Authorization (Prescriber)
    • Complete Humana's PA form
    • Include all required clinical documentation
    • Timeline: Submit electronically for faster processing
  4. Await Initial Decision (Patient)
    • Standard decisions: Up to 14 days for medical PA
    • Part D drug decisions: 7 days standard, 72 hours expedited
    • Track status: Via MyHumana member portal
  5. Specialty Pharmacy Setup (If Approved)
    • Bylvay requires dispensing through CenterWell Specialty Pharmacy
    • Pharmacy will contact patient for delivery coordination
    • Timeline: 3-5 business days for first shipment

Timeline and Urgency

Standard Processing Times

Request Type Standard Timeline Expedited Timeline
Part D Drug PA 7 calendar days 72 hours
Part B Medical PA 14 calendar days 72 hours
Internal Appeal 30-60 days 72 hours
External Review (NY) 45 days 72 hours (24 hours for urgent drugs)

When to Request Expedited Review

Request expedited processing if:

  • Patient has severe, intractable pruritus affecting quality of life
  • Delay could worsen liver function or lead to complications
  • Current treatments have failed and patient needs immediate alternative

Medical Necessity Criteria

For Progressive Familial Intrahepatic Cholestasis (PFIC)

Required Documentation:

  • Genetic confirmation of PFIC types 1, 2, or 3
  • Patient age ≥3 months
  • Documentation of moderate to severe pruritus
  • Evidence of failure or intolerance to ≥2 conventional treatments
  • Prescription by hepatologist or gastroenterologist

For Alagille Syndrome

Required Documentation:

  • JAG1 or NOTCH2 genetic mutation confirmation
  • Patient age ≥12 months (some plans accept ≥3 months)
  • Evidence of cholestasis (elevated bile acids, bilirubin, or GGT)
  • Moderate to severe pruritus documentation
  • Prior treatment failures with conventional therapies
Clinician Corner: Your medical necessity letter should include specific pruritus scoring (if available), impact on sleep and daily activities, previous medication trials with dates and outcomes, and current liver function status. Reference the FDA prescribing information for approved indications.

Understanding Costs

Medicare Cost Structure

  • Deductible phase: Patient pays full cost until deductible met
  • Coverage gap: Patient may pay 25% of drug cost
  • Catastrophic phase: Reduced patient responsibility
  • Annual costs: Can range from $1,471 to over $50,000 depending on plan and phase

Financial Assistance Limitations

Medicare patients cannot access:

  • IPSEN CARES copay assistance programs
  • Manufacturer discount cards
  • Direct financial support from Ipsen

Available options:

  • Independent charitable foundations for rare liver diseases
  • State pharmaceutical assistance programs (varies by eligibility)
  • Medicare Extra Help/Low Income Subsidy programs

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn
Age below threshold Provide updated birthdate documentation; appeal if clinical need exists
Insufficient prior treatments Submit detailed records of ≥2 failed therapies with dates and outcomes
Non-specialist prescriber Transfer care to hepatologist/gastroenterologist
Missing genetic confirmation Obtain molecular genetic testing results
"Not medically necessary" Submit comprehensive clinical documentation and peer-reviewed literature

New York Appeals Process

Internal Appeal (Required First Step):

  • Deadline: 65 days from denial notice
  • Decision time: 7-14 days for Part D, 30-60 days for Part B
  • Submit to: Humana appeals department

External Appeal (New York DFS):

From our advocates: We've seen successful Bylvay appeals when families included detailed pruritus diaries showing sleep disruption and quality of life impact, along with hepatologist letters explaining why conventional treatments failed. The key is connecting clinical evidence to the plan's own coverage criteria.

Renewal Requirements

Reauthorization Timeline

  • Initial approval: Typically 6 months
  • Renewal period: 12 months after initial approval
  • Submit renewal: 30 days before current authorization expires

Required Documentation for Renewal

  • Evidence of pruritus improvement or bile acid reduction
  • Continued specialist oversight
  • No development of portal hypertension or liver decompensation
  • Confirmation that liver transplant has not occurred

Specialty Pharmacy Process

Why Specialty Pharmacy is Required

Bylvay requires special handling due to:

  • High cost and limited distribution
  • Need for patient education and monitoring
  • Insurance verification and prior authorization coordination
  • Temperature-controlled storage and shipping

CenterWell Specialty Pharmacy Services

Humana's CenterWell Specialty Pharmacy provides:

  • 24/7 pharmacist access
  • Medication delivery coordination
  • Financial assistance navigation
  • Clinical support and monitoring

Common Issues and Solutions

Portal and Technical Problems

Issue: Humana provider portal not accepting PA submission Solution: Contact Humana provider services at 1-800-457-4506 for technical support

Issue: Missing required forms or documentation Solution: Download current forms from Humana's provider resources

Coverage Transitions

Issue: Switching from another insurer to Humana Solution: Request continuity of care coverage while PA is processed; New York law may provide transition protections

Frequently Asked Questions

How long does Humana prior authorization take for Bylvay in New York? Standard processing is 7 days for Part D coverage, 14 days for Part B. Expedited requests are processed within 72 hours when urgency is documented.

What if Bylvay is non-formulary on my Humana plan? Request a formulary exception with your prior authorization. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal in New York? Yes, both Humana and New York DFS offer expedited appeals for urgent medical needs. Decisions are made within 72 hours, or 24 hours for urgent drug denials.

Does step therapy apply if I've tried treatments outside New York? Yes, prior treatment history from any location counts toward step therapy requirements. Ensure all documentation is transferred to your New York providers.

What happens if my appeal is denied by Humana? You can file an external appeal with New York DFS within 4 months. Their decision is binding on Humana and has frequently overturned specialty drug denials.

Who can help me navigate the appeals process? Contact Community Health Advocates at 888-614-5400 for free assistance with insurance appeals and understanding your rights in New York.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific rebuttal letters. Our platform analyzes denial reasons and crafts targeted responses using the right clinical evidence and procedural requirements for each insurer and state.

For more guidance on navigating complex prior authorizations and appeals, visit Counterforce Health to learn how we're helping families access critical medications like Bylvay.

Sources and Further Reading

This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions and insurance coverage options. For the most current forms, deadlines, and coverage policies, verify information directly with Humana and New York state agencies.

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