By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (odevixibat) Covered by Aetna (CVS Health) in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Bylvay (odevixibat) Covered by Aetna (CVS Health) in New York

Bylvay (odevixibat) requires prior authorization from Aetna (CVS Health) and is typically non-formulary, requiring a medical exception. The fastest path: Have a pediatric hepatologist or gastroenterologist submit a complete PA packet through Aetna's provider portal with genetic testing, failed prior therapies, and clinical severity documentation. Standard decisions take 1-5 days; expedited reviews are completed within 24 hours. If denied, New York residents can file an external appeal through the Department of Financial Services within 4 months, with decisions binding on Aetna.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Prior Authorization Documentation Checklist
  4. Common Denial Reasons & How to Fix Them
  5. New York Appeals Process for Aetna Denials
  6. Costs and Patient Support Options
  7. Frequently Asked Questions
  8. When to Contact New York Regulators

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Aetna plans Aetna Provider Portal
Formulary Status Non-formulary/medical exception needed Aetna drug formulary guide
Prescriber Pediatric hepatologist/gastroenterologist Medical necessity letter required
Age Requirements PFIC: ≥3 months; Alagille: ≥12 months FDA prescribing information
Genetic Testing Required for diagnosis confirmation Lab report with mutation analysis
Prior Therapies Failed ursodiol + ≥1 antipruritic agent Clinical documentation with dates/outcomes
Appeal Deadline 4 months for NY external review NY Department of Financial Services

Step-by-Step: Fastest Path to Approval

1. Confirm Your Aetna Plan Type

Who does it: Patient/family
What you need: Insurance card, member portal access
Timeline: 15 minutes

Log into your Aetna member portal to verify if you have a New York-regulated plan (individual, small group, or Medicaid managed care). Self-funded employer plans may have different appeal rights.

2. Schedule with a Pediatric Specialist

Who does it: Patient/family
What you need: Referral (if required), insurance verification
Timeline: 1-4 weeks for appointment

Bylvay requires a pediatric hepatologist or gastroenterologist to prescribe. Primary care physicians typically cannot submit successful prior authorizations for this specialty medication.

3. Gather Required Documentation

Who does it: Medical team + family
What you need: See checklist below
Timeline: 1-2 weeks

Collect genetic testing results, prior therapy records, recent labs (bile acids, liver function tests), and growth charts before the PA submission.

4. Submit Complete Prior Authorization

Who does it: Prescriber's office
How to submit: Aetna provider portal or fax
Timeline: Standard 1-5 days; expedited 24 hours

The specialist submits through Aetna's electronic portal with all supporting documentation attached. Request expedited review if severe pruritus is causing sleep disruption or functional impairment.

5. Monitor Decision and Prepare for Appeals

Who does it: Patient + prescriber
What you need: Denial letter (if denied)
Timeline: Ongoing

If approved, coordinate with CVS Specialty Pharmacy for fulfillment. If denied, immediately begin internal appeal preparation.

Prior Authorization Documentation Checklist

Clinician Corner: A complete PA packet significantly increases first-pass approval rates. Include all items below to avoid delays.

Required Clinical Documentation

  • Genetic testing report confirming PFIC (ATP8B1, ABCB11) or Alagille syndrome (JAG1, NOTCH2)
  • Medical necessity letter from pediatric hepatologist/gastroenterologist
  • Recent laboratory results (within 3-6 months):
    • Serum bile acids (elevated)
    • Liver function tests (AST, ALT, GGT, bilirubin, alkaline phosphatase)
    • Fat-soluble vitamin levels (A, D, E, K)
  • Prior therapy documentation with specific details:
    • Ursodeoxycholic acid (dose, duration, response)
    • At least one antipruritic agent (rifampin, cholestyramine, naltrexone, antihistamines)
    • Dates started/stopped and reasons for discontinuation
  • Clinical severity documentation:
    • Pruritus severity scores or clinical notes
    • Sleep disturbance documentation
    • Growth charts showing impact
    • Photos of skin excoriations (if applicable)

Medical Necessity Letter Key Elements

Your specialist's letter should include:

  • Confirmed diagnosis with ICD-10 codes
  • Age verification meeting FDA indications
  • Detailed prior treatment failures
  • Current symptom severity and functional impact
  • Weight-based dosing justification
  • Monitoring plan

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Lack of specialist involvement Ensure pediatric hepatologist/GI submits request Specialist credentials and consultation notes
Insufficient prior therapy records Document specific drugs, doses, durations, outcomes Pharmacy records, clinical notes with dates
Age below FDA threshold Verify patient age meets requirements Birth certificate, medical records
Non-formulary status Request medical exception with clinical justification Comparative effectiveness data, specialist letter
Experimental/investigational Emphasize FDA approval for PFIC/Alagille FDA prescribing information, clinical guidelines
Dosing outside guidelines Provide weight-based calculation rationale Growth charts, dosing calculations, specialist justification

New York Appeals Process for Aetna Denials

New York provides robust appeal rights through the Department of Financial Services (DFS) external review program.

Internal Appeal with Aetna

  • Deadline: 180 days from denial
  • Timeline: 30 days standard; 72 hours expedited
  • How to file: Aetna member portal or written request
  • Required: Original denial letter, new supporting evidence

External Appeal through NY DFS

  • Deadline: 4 months after Aetna's final adverse determination
  • Timeline: 30 days standard; 72 hours expedited; 24 hours for urgent non-formulary drugs
  • Cost: $25 maximum (waived for financial hardship/Medicaid)
  • Forms needed:

Submit to:

  • Mail: NY Department of Financial Services, 99 Washington Avenue, Box 177, Albany, NY 12210
  • Fax: (800) 332-2729
  • Expedited: Fax + call 888-990-3991
Note: External appeal decisions are binding on Aetna. New York's program has helped overturn many specialty drug denials when proper documentation is provided.

Free Help Available

Community Health Advocates provides free assistance with appeals at 888-614-5400. They can help New Yorkers file appeals and understand their rights under state law.

Costs and Patient Support Options

IPSEN CARES Program

The manufacturer offers comprehensive support through IPSEN CARES:

  • Benefits verification and prior authorization assistance
  • Copay program reducing out-of-pocket costs to $0 for eligible patients
  • Specialty pharmacy coordination including CVS Specialty
  • Appeals support with dedicated case managers
  • Contact: 866-435-5677 (8am-8pm ET, Monday-Friday)

CVS Specialty Pharmacy Enrollment

Once approved, Bylvay is typically dispensed through CVS Specialty Pharmacy:

  • Complete enrollment form available on CVS website
  • Patient education and adherence support
  • Coordination with IPSEN CARES copay program
  • Refill reminders and clinical monitoring

Alternative Financial Assistance

  • Patient Advocate Foundation: Co-pay relief for qualifying patients
  • HealthWell Foundation: Grants for rare disease medications
  • State pharmaceutical assistance programs: Check with New York Department of Health

When it comes to navigating complex prior authorization requirements for rare disease treatments like Bylvay, having expert support can make all the difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific documentation that addresses each denial reason with targeted clinical and policy arguments.

Frequently Asked Questions

How long does Aetna prior authorization take for Bylvay in New York? Standard prior authorization decisions are typically made within 1-5 days for complete submissions. Expedited reviews (for urgent clinical situations) must be completed within 24 hours per Aetna policy.

What if Bylvay is not on my Aetna formulary? Most Aetna plans list Bylvay as non-formulary, requiring a medical exception. Your specialist can request coverage based on medical necessity, FDA approval, and lack of therapeutic alternatives.

Can I get an expedited appeal if denied? Yes. New York allows expedited external appeals when delay would seriously jeopardize health or when you're currently taking a non-formulary medication. Decisions must be made within 72 hours (24 hours for urgent non-formulary drugs).

Does step therapy apply to Bylvay? Aetna typically requires documentation of failed or inadequate response to ursodeoxycholic acid and at least one antipruritic medication before approving Bylvay.

What if I'm already taking Bylvay and my plan changes? New York law may require Aetna to continue coverage through the plan year for established patients. Contact Community Health Advocates at 888-614-5400 for assistance.

How much does Bylvay cost without insurance? Annual costs can range from approximately $170,000 to $530,000 depending on the patient's weight and required dosing. The IPSEN CARES copay program can reduce out-of-pocket costs to $0 for eligible patients.

Can my pediatrician prescribe Bylvay? While pediatricians can technically prescribe Bylvay, prior authorization success rates are significantly higher when submitted by pediatric hepatologists or gastroenterologists familiar with the clinical evidence and payer requirements.

What happens if the external appeal is denied? External appeal decisions through New York DFS are final and binding. However, you may still pursue other options such as filing complaints with state regulators or seeking legal counsel for potential bad faith denial claims.

When to Contact New York Regulators

Contact the New York Department of Financial Services if:

  • Aetna fails to respond to appeals within required timeframes
  • You believe Aetna is improperly denying medically necessary care
  • You need assistance understanding your appeal rights
  • You want to file a complaint about claims handling practices

DFS Contact Information:

  • Phone: 1-800-342-3736
  • Online: File complaints through the DFS website
  • Mail: Consumer Protection Unit, New York State Department of Financial Services, One State Street, New York, NY 10004
From our advocates: We've seen families successfully overturn Bylvay denials by focusing on three key elements: genetic confirmation of diagnosis, detailed documentation of failed prior therapies with specific dates and outcomes, and clear evidence of functional impact from uncontrolled pruritus. The combination of specialist involvement and comprehensive clinical documentation significantly improves approval odds, especially when families understand their appeal rights under New York law.

For complex cases requiring targeted appeal strategies, Counterforce Health specializes in analyzing denial letters and crafting point-by-point rebuttals that address payer-specific criteria while incorporating the clinical evidence most likely to result in approval.

Sources & Further Reading

Disclaimer: This article provides general information about insurance coverage and appeal processes and should not be considered medical or legal advice. Insurance policies, coverage criteria, and state regulations may change. Always verify current requirements with your specific Aetna plan and consult with healthcare professionals regarding medical decisions. For personalized assistance with appeals, consider contacting the resources mentioned above or consulting with qualified patient advocates.

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