How to Get Bylvay (odevixibat) Covered by Humana in Washington: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Bylvay (Odevixibat) Covered by Humana in Washington
Bylvay requires prior authorization from Humana for PFIC (≥3 months) or Alagille syndrome (≥12 months). Submit genetic testing results, specialist diagnosis, and prior therapy documentation to Humana's specialty pharmacy team. First step: Enroll in IPSEN CARES for $0 copay assistance and PA support. If denied, use Washington's Independent Review Organization (IRO) process through the Office of the Insurance Commissioner within 180 days. Standard PA decisions: 7 days; expedited: 72 hours.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Prior Authorization Documentation
- Common Denial Reasons & Solutions
- Appeals Process in Washington
- Cost Reduction Strategies
- Specialty Pharmacy Requirements
- When to Contact Washington Regulators
- Frequently Asked Questions
Coverage Requirements at a Glance
| Requirement | Details | Where to Verify | Source |
|---|---|---|---|
| Prior Authorization | Required before first fill | Humana provider portal | Humana Policy |
| Age Limits | PFIC: ≥3 months; Alagille: ≥12 months | FDA prescribing information | FDA Label |
| Specialty Pharmacy | CenterWell or approved network only | Humana specialty pharmacy finder | Humana Network |
| Genetic Testing | Required for diagnosis confirmation | Medical records | Clinical Standard |
| Appeals Deadline | 65 days from denial (Medicare) | Member handbook | CMS Guidelines |
| External Review | 180 days from final denial | Washington OIC | RCW 48.43.535 |
Step-by-Step: Fastest Path to Approval
1. Enroll in Patient Support (Day 1)
Who: Patient or caregiver
Action: Complete IPSEN CARES enrollment for benefits verification and PA assistance
Timeline: 2-3 business days for verification
2. Gather Required Documentation (Days 1-3)
Who: Healthcare provider
Documents needed:
- Genetic testing confirming PFIC or Alagille syndrome
- Specialist diagnosis with ICD-10 codes
- Prior therapy trials and outcomes
- Weight-based dosing rationale
- Lab results showing cholestasis severity
3. Submit Prior Authorization (Day 4)
Who: Prescriber or IPSEN CARES team
Method: Fax to 877-486-2621 with confirmation receipt
Timeline: 7 days standard; 72 hours expedited
4. Follow Up on Decision (Day 7-10)
Who: Patient or clinic staff
Action: Call Humana member services to confirm receipt and track status
Contact: Number on insurance card
5. If Denied: Request Internal Appeal (Within 65 days)
Who: Patient, prescriber, or authorized representative
Method: Humana appeals portal or fax
Timeline: 7 days for Part D appeals
6. If Still Denied: File External Review (Within 180 days)
Who: Patient or representative
Method: Contact Washington Office of Insurance Commissioner at 1-800-562-6900
Timeline: 30 days for standard; 72 hours for expedited
Clinician Corner: Medical Necessity Letter Checklist
Your medical necessity letter should address:
✓ Confirmed diagnosis with genetic testing results and ICD-10 codes
✓ Symptom severity including pruritus impact on quality of life
✓ Prior therapies tried with specific dates, dosages, and reasons for discontinuation
✓ Clinical rationale for Bylvay based on FDA-approved indications
✓ Weight-based dosing calculation and monitoring plan
✓ Treatment goals and expected outcomes
Key Citations to Include:
- FDA prescribing information for Bylvay
- Relevant clinical guidelines for PFIC or Alagille syndrome management
- Published studies supporting efficacy in pediatric cholestatic conditions
Common Denial Reasons & Solutions
| Denial Reason | Solution Strategy | Required Documentation |
|---|---|---|
| Age below threshold | Provide birth certificate and current weight | Medical records showing exact age |
| Lack of specialist diagnosis | Obtain referral to pediatric hepatologist | Specialist consultation notes |
| Insufficient prior therapy | Document failed conventional treatments | Pharmacy records, provider notes |
| Off-label use | Confirm FDA-approved indication | Genetic testing, diagnosis confirmation |
| Quantity limits exceeded | Justify weight-based dosing | Growth charts, dosing calculations |
Appeals Process in Washington
Internal Appeals (Humana)
Timeline: 65 days from denial notice
Standard Review: 7 days for Part D prescription drugs
Expedited Review: 72 hours if health at risk
Submission: Humana member portal or fax 877-486-2621
External Review (Washington State)
Washington's Independent Review Organization (IRO) process provides an impartial review when Humana's internal appeals are unsuccessful.
Eligibility: Available after completing internal appeals
Timeline: 180 days from final internal denial to request
Process: Contact Washington Office of Insurance Commissioner at 1-800-562-6900
Decision Timeline: 30 days standard; 72 hours expedited
Outcome: Binding on Humana if overturned
Note: Washington law (RCW 48.43.535) allows external review for any denial based on medical necessity, even if the insurer's definition differs from standard medical practice.
Cost Reduction Strategies
IPSEN CARES Patient Support
Copay Assistance: Reduces costs to $0 for eligible patients with commercial insurance
Eligibility: U.S. residents with private insurance (Medicare Part D patients ineligible)
Application: IPSEN CARES website
Foundation Support
Alagille Syndrome Alliance: Financial assistance through ALGSAssistance Form
PFIC Network: Support coordination for families worldwide
National Organization for Rare Disorders (NORD): Emergency financial assistance at (800) 411-1222
Washington State Resources
Apple Health (Medicaid): May cover Bylvay for eligible low-income residents
Washington Healthplanfinder: Marketplace plans with potential coverage
Clinical Trials: Seattle Children's Hospital participates in Alagille syndrome research
When to Contact Washington Regulators
Contact the Washington Office of Insurance Commissioner if:
- Humana fails to respond within required timelines
- You need help understanding your appeal rights
- The denial seems inconsistent with medical evidence
- You want to file a complaint about the appeals process
Consumer Advocacy Line: 1-800-562-6900
Services: Appeal guidance, complaint filing, IRO process assistance
Patient Support and Advocacy
Counterforce Health specializes in turning insurance denials into successful appeals through evidence-backed strategies. The platform analyzes denial letters, identifies specific coverage criteria, and generates targeted rebuttals using clinical evidence and payer-specific workflows. For complex cases like Bylvay coverage, this systematic approach can significantly improve approval odds by ensuring all medical necessity requirements are properly addressed.
For patients navigating Humana's prior authorization process, having expert support can make the difference between a quick approval and months of delays. The combination of proper documentation, strategic appeal timing, and Washington's strong external review process creates multiple pathways to coverage.
From our advocates: We've seen families succeed with Bylvay appeals by focusing on three key elements: comprehensive genetic testing documentation, detailed prior therapy records showing conventional treatment failures, and specialist letters that directly address Humana's specific medical necessity criteria. The strongest cases include growth charts for pediatric patients and quality-of-life assessments showing pruritus impact.
Frequently Asked Questions
How long does Humana's prior authorization take for Bylvay in Washington?
Standard decisions: 7 days for Part D prescription drugs. Expedited reviews: 72 hours if medically urgent. Submit through Humana's provider portal or fax 877-486-2621.
What if Bylvay is non-formulary on my Humana plan?
Request a formulary exception through Humana's member portal. Include prescriber documentation showing why formulary alternatives are ineffective or contraindicated.
Can I get expedited review if my child's pruritus is severe?
Yes. If waiting could seriously harm health or function, request expedited review. Call 800-867-6601 or check the expedited box on appeal forms.
Does step therapy apply if we tried treatments outside Washington?
Treatment history from any licensed provider typically counts. Include pharmacy records and provider notes documenting failed therapies, regardless of location.
What happens if Humana denies my external review request?
Washington's IRO process is automatic once you request it. Humana cannot block external review. Contact the Washington OIC at 1-800-562-6900 for assistance.
How much does Bylvay cost without insurance?
$14,152–$44,562 per month depending on strength, with annual costs potentially reaching $106,000. IPSEN CARES offers copay assistance and patient assistance programs.
Sources & Further Reading
- Humana Pharmacy Coverage Policies
- Washington Office of Insurance Commissioner Appeals Process
- IPSEN CARES Patient Support Program
- Humana Member Appeals Portal
- Washington State External Review Law (RCW 48.43.535)
- FDA Bylvay Prescribing Information
- Seattle Children's Hospital Hepatology Program
This article is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals in Washington, contact the Office of Insurance Commissioner at 1-800-562-6900.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.