By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (Odevixibat) Covered by Humana in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Bylvay (Odevixibat) Covered by Humana in Michigan

Humana requires prior authorization for Bylvay (odevixibat) to treat pruritus in PFIC (≥3 months) or Alagille syndrome (≥12 months). Submit PA via Humana's provider portal with specialist documentation, diagnosis confirmation, pruritus severity scores, and prior treatment failures. If denied, file a redetermination request within 65 days using Humana's Medicare Part D appeal form. Michigan residents can escalate to external review through DIFS within 127 days of final denial.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Coverage Criteria
  5. Costs and Financial Support
  6. Denials and Appeals
  7. Renewals and Reauthorization
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Bylvay (Odevixibat) Covered by Humana?

Yes, Humana Medicare Advantage and Part D plans cover Bylvay (odevixibat) with prior authorization. Humana's pharmacy policies for Bylvay were last updated in 2025 and remain effective through at least January 1, 2026.

Which Humana Plans Include Coverage?

  • Medicare Advantage (Part C) plans with prescription drug coverage
  • Medicare Part D standalone prescription drug plans
  • Coverage varies by specific plan formulary tier and may include quantity limits
Note: Verify your specific plan's formulary status by calling Humana at 1-800-451-4651 or checking your member portal.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician (typically a hepatologist or gastroenterologist) must submit the prior authorization request. Patients cannot submit PA requests directly to Humana.

Step-by-Step: Fastest Path to Approval

  1. Prescriber gathers documentation (diagnosis, labs, prior treatments) - 1-2 days
  2. Submit PA via Humana provider portal - same day
  3. Humana reviews request - up to 7 days for standard, 72 hours for expedited
  4. Approval notification sent to prescriber and pharmacy - same day as decision
  5. Specialty pharmacy dispenses medication - 1-3 business days
  6. Patient receives medication - varies by shipping method
  7. Follow up for renewals - typically required annually

Required Documentation Checklist

  • ✅ FDA-approved diagnosis (PFIC or Alagille syndrome with cholestatic pruritus)
  • ✅ Age verification (≥3 months for PFIC, ≥12 months for Alagille syndrome)
  • ✅ Specialist confirmation (hepatologist or gastroenterologist)
  • ✅ Pruritus severity assessment and scoring
  • ✅ Documentation of prior treatment failures or contraindications
  • ✅ Current lab results (serum bile acids, liver function tests)
  • ✅ Weight-based dosing calculation (40-120 mcg/kg/day)

Timing and Urgency

Standard Review Timeline

Humana processes standard prior authorization requests within 7 calendar days of receiving complete documentation. Incomplete requests may take longer and require additional information.

Expedited Review Process

For urgent cases where waiting 7 days could seriously harm the patient's health, prescribers can request expedited review by calling 1-800-451-4651. Expedited requests are decided within 72 hours and require:

  • Prescriber attestation that delay would cause serious health consequences
  • Clinical justification for urgency
  • Complete medical documentation

Coverage Criteria

Medical Necessity Requirements

Requirement PFIC Patients Alagille Syndrome Patients
Minimum Age ≥3 months ≥12 months
Diagnosis Progressive familial intrahepatic cholestasis Alagille syndrome
Symptom Cholestatic pruritus Cholestatic pruritus
Severity Moderate to severe Moderate to severe
Prior Therapy Failure/intolerance of ≥2 systemic treatments Failure/intolerance of ≥2 systemic treatments
Prescriber Hepatologist or gastroenterologist Hepatologist or gastroenterologist

Weight-Based Dosing Requirements

PFIC Dosing:

  • Start: 40 mcg/kg/day
  • Titrate: Increase by 40 mcg/kg every 3 months if no improvement
  • Maximum: 120 mcg/kg/day or 6 mg/day (whichever is lower)

Alagille Syndrome Dosing:

  • Standard: 120 mcg/kg/day
  • If tolerability issues: Reduce to 40 mcg/kg/day, then re-escalate
  • Maximum: 7.2 mg/day

Source: FDA prescribing information

Costs and Financial Support

Medicare Part D Cost Sharing

With the 2026 Medicare changes, your annual out-of-pocket costs for prescription drugs are capped at $2,100. Bylvay's high cost means most patients will reach this cap, after which Medicare covers 100% of costs.

Patient Assistance Programs

IPSEN CARES Program:

Medicare Extra Help:

From our advocates: "We've seen families save thousands by applying for both manufacturer assistance and Medicare Extra Help simultaneously. Even if you think your income is too high, it's worth checking eligibility—the income limits are higher than many people expect, especially for larger households."

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Age below threshold Confirm patient meets minimum age requirements Birth certificate, medical records
Lack of specialist diagnosis Obtain hepatologist/gastroenterologist evaluation Specialist consultation notes
Insufficient prior therapy Document failure/intolerance of ≥2 treatments Treatment history with dates, doses, outcomes
Missing pruritus severity Provide validated pruritus scoring Pruritus assessment tools, patient-reported outcomes
Off-label use Demonstrate FDA-approved indication Diagnosis confirmation, ICD-10 codes

Appeals Process for Humana in Michigan

Level 1: Redetermination (Internal Appeal)

Level 2: Independent Review (External Appeal)

  • Deadline: 60 days from redetermination denial
  • Timeline: 30 days standard, 72 hours expedited
  • Entity: Independent Review Organization contracted by Medicare

Michigan External Review (State Level)

  • Deadline: 127 days from final internal denial
  • Timeline: 60 days standard, 72 hours expedited
  • How to file: DIFS External Review Request online or by mail
  • Phone: 877-999-6442

Medical Necessity Letter Template

When appealing, your prescriber should include:

  1. Patient's specific diagnosis with ICD-10 codes
  2. Severity of cholestatic pruritus with objective measures
  3. Prior treatment failures with specific medications, doses, durations, and reasons for discontinuation
  4. Clinical rationale for Bylvay based on FDA labeling and medical literature
  5. Weight-based dosing justification per prescribing information
  6. Treatment goals and expected outcomes
  7. Monitoring plan for efficacy and safety

Renewals and Reauthorization

When to Reauthorize

Most Humana plans require annual reauthorization for Bylvay. Start the renewal process 30-60 days before your current authorization expires to avoid treatment interruptions.

Renewal Documentation

  • Updated clinical assessment of pruritus improvement
  • Current lab results (bile acids, liver function)
  • Confirmation of continued medical necessity
  • Assessment for disease progression or complications
  • Weight-based dose adjustments if needed

Specialty Pharmacy Requirements

Why Specialty Pharmacy?

Bylvay is typically dispensed through specialty pharmacies due to:

  • High cost and complex handling requirements
  • Need for patient education and monitoring
  • Coordination with prescriber for dose adjustments
  • Prior authorization management

Common Specialty Pharmacy Partners

Humana works with several specialty pharmacy networks. Your medication may be transferred to:

  • Express Scripts Specialty Pharmacy
  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Other contracted specialty pharmacies
Tip: Ask your prescriber to specify a preferred specialty pharmacy when submitting the prior authorization to avoid delays.

Troubleshooting Common Issues

Portal Access Problems

If you can't access Humana's online portal:

  • Clear browser cache and cookies
  • Try a different browser
  • Call Humana member services at 1-800-451-4651
  • Use alternative submission methods (fax, mail)

Missing Forms or Documents

  • Download current forms from Humana's documents page
  • Verify form version dates match current requirements
  • Contact your prescriber's office for clinical documentation
  • Request copies of denial letters from Humana if needed

Delayed Responses

If Humana hasn't responded within standard timeframes:

  • Call member services to check status
  • Request expedited review if medically urgent
  • Document all communication attempts
  • Consider filing a complaint with Michigan DIFS if delays persist

Frequently Asked Questions

Q: How long does Humana prior authorization take for Bylvay in Michigan? A: Standard requests take up to 7 calendar days. Expedited requests are processed within 72 hours when medical urgency is documented by the prescriber.

Q: What if Bylvay is not on Humana's formulary? A: You can request a formulary exception through the same prior authorization process. Your prescriber must demonstrate medical necessity and why formulary alternatives are inappropriate.

Q: Can I request an expedited appeal if my child needs Bylvay urgently? A: Yes, if your prescriber can document that waiting for standard review would seriously harm your child's health. Call 1-800-451-4651 to request expedited processing.

Q: Does step therapy apply to Bylvay? A: While not explicitly listed in Humana's 2024 step therapy requirements, you may need to document failure of conventional treatments like ursodiol before Bylvay approval.

Q: What happens if I can't afford the copay? A: Apply for the IPSEN CARES program for potential $0 copay assistance. Also check eligibility for Medicare Extra Help to reduce overall prescription costs.

Q: How do I know if my appeal was successful? A: Humana will send written notification to both you and your prescriber. You can also check status through your member portal or by calling member services.

Q: What if Humana denies my appeal? A: You can escalate to an Independent Review Organization (Medicare level) or file an external review with Michigan DIFS within 127 days of the final denial.

Q: Can I get Bylvay while my appeal is pending? A: Generally no, unless you pay out-of-pocket. However, if it's an expedited appeal for urgent medical need, ask your prescriber about emergency supplies or alternative arrangements.

Getting Help with Complex Cases

When standard approaches aren't working, specialized support can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's own rules.

For medications like Bylvay, Counterforce Health pulls the right evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with all the required clinical facts, from diagnosis codes to weight-based dosing justifications. This systematic approach has helped many families navigate complex prior authorization and appeals processes when traditional methods fall short.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may vary by specific plan and change over time. Always verify current requirements with Humana directly and consult with your healthcare provider about treatment decisions. For questions about Michigan insurance regulations or to file complaints, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

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