By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (odevixibat) Covered by UnitedHealthcare in New York: Prior Authorization, Appeals, and Alternative Paths

Answer Box: Getting Bylvay Covered by UnitedHealthcare in New York

Bylvay (odevixibat) requires prior authorization from UnitedHealthcare in New York. Most plans use either a Notification policy (lighter requirements) or Medical Necessity policy (requires failure of 2+ conventional cholestatic treatments first). If denied, New York offers strong external appeal protections through the Department of Financial Services with 4-month filing windows and binding decisions. First step today: Have your pediatric GI/hepatologist check your exact UnitedHealthcare plan policy on the provider portal and gather documentation of PFIC/Alagille diagnosis plus any prior treatment failures.

Table of Contents

Coverage Requirements Overview

UnitedHealthcare covers Bylvay for PFIC and Alagille syndrome cholestatic pruritus, but requirements vary significantly by plan type. Understanding which policy track applies to your specific plan is crucial for success.

Coverage at a Glance

Requirement Notification Policy Medical Necessity Policy Source
Prior Authorization Required Required UHC PA Portal
Step Therapy None explicitly stated 2+ conventional treatments UHC Policy Documents
Specialist Required GI/Hepatology recommended Pediatric GI/Hepatologist required UHC Provider Criteria
Age Limits ≥3 months (PFIC), ≥12 months (Alagille) Same FDA Label Requirements
Approval Term 12 months typically 12 months with renewal criteria UHC Standard Practice
Formulary Status Tier 3 with PA + Specialty Pharmacy Tier 3 with PA + Specialty Pharmacy UHC Formulary
Note: Your prescriber must check the UnitedHealthcare Provider Portal to determine which policy applies to your specific plan, as this varies by product type (commercial, exchange, Medicare).

When Alternatives Make Sense

Before pursuing a Bylvay exception or appeal, it's worth understanding when formulary alternatives might be appropriate—and when they're not suitable for your situation.

Alternatives may be reasonable when:

  • Your child hasn't tried conventional cholestatic pruritus treatments yet
  • Bylvay is non-formulary and you need coverage while appealing
  • You're waiting for PA approval and need immediate symptom management
  • Cost considerations are significant (alternatives are typically much less expensive)

Skip alternatives and go straight to Bylvay exception when:

  • Multiple conventional treatments have already failed or caused intolerable side effects
  • Your child has contraindications to standard therapies (e.g., severe liver dysfunction for rifampin)
  • Previous Bylvay response was excellent and you're switching plans
  • Disease progression is rapid and delay could be harmful

Typical Formulary Alternatives

UnitedHealthcare's step therapy requirements typically expect trial of these conventional cholestatic pruritus treatments before approving Bylvay:

First-Line Options

Ursodeoxycholic Acid (UDCA)

  • Mechanism: Improves bile flow and has modest antipruritic effects
  • Typical dosing: 10-20 mg/kg/day divided twice daily
  • UHC coverage: Usually covered without PA on most formularies
  • Response rate: Studies show ~67% achieve ≥50% itch reduction

Cholestyramine

  • Mechanism: Bile acid sequestrant that reduces circulating bile acids
  • Typical dosing: 4-16 g/day divided (start low, titrate up)
  • UHC coverage: Generic typically covered without restrictions
  • Response rate: ~55-64% VAS reduction in small studies

Second-Line Options

Rifampin

  • Mechanism: Induces hepatic enzymes, reduces bile acid synthesis
  • Typical dosing: 5-10 mg/kg twice daily (max 300 mg twice daily)
  • UHC coverage: Usually covered, may require PA for cholestatic indications
  • Response rate: ~55% itch reduction vs. placebo in pediatric cholestasis

Naltrexone

  • Mechanism: Opioid receptor antagonist
  • Typical dosing: 0.5-1 mg/kg/day (off-label in children)
  • UHC coverage: May require PA for cholestatic pruritus indication
  • Response rate: 70-90% of patients show marked improvement

Pros and Cons of Each Option

Treatment Pros Cons Key Considerations
UDCA • Well-tolerated
• May improve liver function
• Covered without PA		 • Limited antipruritic effect alone
• May be insufficient in severe cases		 Best as combination therapy
Cholestyramine • Rapid onset (7-10 days)
• Inexpensive
• Long track record		 • Poor palatability
• Can worsen malabsorption
• Drug interactions		 Separate from other meds by 4+ hours
Rifampin • Effective for pruritus
• Relatively fast onset		 • Hepatotoxicity risk
• Contraindicated if bilirubin >2.5
• Multiple drug interactions		 Requires frequent lab monitoring
Naltrexone • Highly effective
• Fast onset (24-48h)		 • Risk of opioid withdrawal
• Neuropsychiatric effects
• Off-label in children		 Screen for opioid use history

Exception Strategy for Bylvay

When conventional alternatives aren't appropriate, a strong exception request can often succeed with UnitedHealthcare, especially in New York where external appeal protections are robust.

Step-by-Step Exception Process

  1. Verify Plan Policy
    • Have prescriber log into UHC Provider Portal
    • Download exact Bylvay PA criteria for your plan
    • Note whether Notification or Medical Necessity track applies
  2. Gather Documentation
    • Confirmed PFIC or Alagille syndrome diagnosis (genetic testing if available)
    • Detailed pruritus assessment (severity scales, sleep disruption, skin damage)
    • Complete treatment history table with dates, doses, responses, and adverse effects
    • Current liver function tests and bile acid levels
    • Growth charts showing any failure to thrive
  3. Submit Strong Initial PA
    • Use UHC's electronic PA tool when possible for faster processing
    • Include specialist letter addressing each PA criteria point
    • Attach supporting literature on Bylvay's FDA-approved indications
    • Request expedited review if child's condition is deteriorating
  4. If Denied, Appeal Immediately
    • File Level 1 internal appeal within 180 days
    • Request peer-to-peer review between your specialist and UHC medical director
    • Emphasize rarity of condition and lack of reasonable alternatives
From our advocates: We've seen families succeed with Bylvay appeals by focusing on the progressive nature of PFIC and Alagille syndrome. One effective approach is documenting how conventional treatments either failed or caused concerning side effects, then emphasizing that Bylvay targets the underlying bile acid transport mechanism rather than just managing symptoms. This mechanistic difference often resonates with medical reviewers.

Switching Logistics

If you need to try alternatives while appealing for Bylvay, coordination between your specialist and pharmacy is essential.

Provider Coordination

  • Hepatology oversight: All cholestatic pruritus treatments should be managed by pediatric GI/hepatology
  • Monitoring schedule: Weekly labs initially, then biweekly for rifampin; monthly for others
  • Documentation: Keep detailed symptom diaries and objective measures (sleep quality, scratch marks, growth)
  • Timeline: Allow 2-4 weeks per treatment trial before declaring failure

Pharmacy Considerations

  • Drug interactions: Cholestyramine can bind other medications—timing is crucial
  • Specialty pharmacy: Some alternatives may also require specialty dispensing
  • Insurance coordination: Ensure prior authorizations are in place before switching
  • Supply management: Don't stop current therapy until new treatment is confirmed available

Re-trying for Bylvay Later

If you try alternatives first (whether by choice or requirement), building a strong case for Bylvay becomes easier with documented treatment failures.

What to Document During Alternative Trials

Objective Measures

  • Pre/post treatment lab values (bilirubin, bile acids, liver enzymes)
  • Standardized pruritus scores (5D itch scale or visual analog scale)
  • Sleep quality assessments and growth measurements
  • Photographic documentation of skin changes

Treatment Response Documentation

  • Exact medications tried, with specific doses and duration
  • Reasons for discontinuation (lack of efficacy vs. adverse effects)
  • Any temporary improvements that weren't sustained
  • Impact on quality of life and daily functioning

Safety Concerns

  • Laboratory abnormalities that developed during treatment
  • Adverse effects that limited dosing or required discontinuation
  • Contraindications that emerged (e.g., rising bilirubin with rifampin)

This documentation becomes powerful evidence for medical necessity when you resubmit for Bylvay approval.

New York Appeals Process

New York offers some of the strongest patient protections in the nation for insurance appeals, with binding external review through the Department of Financial Services.

Internal Appeals (Required First Step)

  • Timeline: Must file within 180 days of denial
  • Expedited option: 24-48 hour decisions for urgent cases
  • Documentation: Submit all new evidence and specialist letters
  • Peer-to-peer: Request direct physician-to-physician discussion

External Appeals Through DFS

  • Filing window: 4 months after final internal denial (extended from 60 days in 2025)
  • Cost: Maximum $25 fee (waived for Medicaid or financial hardship)
  • Timeline: 72 hours for urgent cases, standard timeframes for non-urgent
  • Decision: Binding on UnitedHealthcare if overturned
  • Success rate: Approximately 57% overturn rate for complex specialty drug appeals

How to File External Appeal

  1. Contact DFS: Call 1-800-NYS-APPEAL or use online portal
  2. Free assistance: Community Health Advocates at 888-614-5400
  3. Required documents: Denial letters, medical records, specialist support
  4. Mark urgent: If delay could seriously jeopardize health

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the exact denial basis and draft point-by-point rebuttals. For complex cases like Bylvay in rare cholestatic diseases, having expert support can significantly improve your chances of approval through both internal appeals and New York's external review process.

FAQ

How long does UnitedHealthcare prior authorization take for Bylvay in New York? Standard PA decisions are typically made within 72 hours for Medicare plans and 15 days for commercial plans. Expedited reviews (when delay could harm health) must be decided within 24 hours.

What if Bylvay isn't on my UnitedHealthcare formulary? You can request a formulary exception along with the PA. Document why covered alternatives are inappropriate for your child's specific PFIC or Alagille syndrome presentation.

Can I request an expedited appeal if my child's condition is worsening? Yes. Both UnitedHealthcare internal appeals and New York external appeals offer expedited timelines (24-72 hours) when delay could seriously jeopardize health.

Does step therapy apply if my child tried treatments in another state? Treatment history from other states should count toward step therapy requirements. Include detailed documentation of all prior therapies regardless of where they were tried.

What counts as "medical necessity" for Bylvay? FDA-approved indications (PFIC or Alagille syndrome cholestatic pruritus), appropriate age, specialist prescribing, and documented failure/intolerance of conventional alternatives where required by your specific plan.

How much does Bylvay cost without insurance? Annual costs can reach $106,000+ depending on dosing. Ipsen offers patient assistance programs—check eligibility at their official patient support website.

Can I appeal to New York state if UnitedHealthcare denies coverage? Yes. After exhausting internal appeals, you have 4 months to file an external appeal with the New York Department of Financial Services, which can make binding coverage decisions.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Insurance coverage decisions depend on individual circumstances and specific plan terms. Always consult with your healthcare provider about treatment decisions and verify current coverage requirements with your insurer. For personalized help with appeals, consider contacting Counterforce Health or New York's free consumer assistance programs.

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