By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (odevixibat) Covered by Cigna in New Jersey: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Bylvay (odevixibat) Covered by Cigna in New Jersey

Eligibility: Bylvay requires prior authorization from Cigna for PFIC (≥3 months) or Alagille syndrome (≥12 months) with documented moderate-to-severe pruritus and failed conventional therapies.

Fastest path: Submit complete PA through Express Scripts portal with genetic testing, specialist consultation, and documented treatment failures. If denied, use New Jersey's IHCAP external review (68% success rate for rare disease drugs).

First step today: Contact your hepatologist or pediatric gastroenterologist to gather genetic testing results and treatment history, then request they initiate Cigna's prior authorization process through Accredo Specialty Pharmacy.

Table of Contents

Understanding Cigna's Bylvay Coverage Requirements

Cigna requires prior authorization for Bylvay (odevixibat) through their specialty pharmacy partner, Express Scripts/Accredo. The drug carries a high cost—ranging from $14,152 to $44,562 per 30 capsules depending on strength—making documentation crucial for approval.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Bylvay prescriptions Express Scripts portal Cigna PA Policy
Age Limits PFIC: ≥3 months; ALGS: ≥12 months FDA prescribing information FDA Label
Specialist Required Hepatologist or pediatric gastroenterologist Cigna policy criteria Cigna PA Policy
Genetic Testing PFIC or ALGS confirmation required Clinical documentation Cigna PA Policy
Prior Therapies Must document failures/intolerance Treatment history records Cigna PA Policy

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Family)

Timeline: 1-2 weeks

  • Insurance card (both sides)
  • Genetic testing results confirming PFIC or Alagille syndrome
  • Complete treatment history including failed therapies
  • Recent liver function tests and fat-soluble vitamin levels

2. Specialist Consultation (Clinician)

Timeline: 1-2 appointments Your hepatologist or pediatric gastroenterologist must:

  • Confirm diagnosis with genetic testing
  • Document moderate-to-severe pruritus
  • Record failed conventional therapies (ursodeoxycholic acid plus one symptom-relief medication)
  • Complete weight-based dosing calculations (40-120 mcg/kg daily)

3. Submit Prior Authorization (Clinician)

Timeline: Same day if complete Submit through Express Scripts ExpressPAth portal or fax to Accredo at 888.302.1028. Include:

  • Completed Accredo enrollment form
  • Medical necessity letter
  • Genetic testing results
  • Treatment failure documentation
  • Current lab values

4. Cigna Review Process

Timeline: 5-10 business days Cigna reviews against their published criteria. Missing documentation delays approval.

5. Approval or Denial Notification

Timeline: Within 15 days

  • If approved: Accredo contacts patient for delivery coordination
  • If denied: Proceed to appeals process (see below)
Tip: Using the electronic portal significantly speeds up the process compared to fax submissions.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Age below threshold Confirm patient meets minimum age (PFIC: 3 months; ALGS: 12 months) Birth certificate, medical records
Lack of genetic confirmation Submit genetic testing results Laboratory reports showing PFIC or ALGS mutations
Insufficient prior therapy trials Document specific failed treatments with dates and outcomes Treatment logs, pharmacy records
Non-specialist prescriber Transfer care or obtain consultation Referral to hepatologist/pediatric GI
Inadequate pruritus documentation Provide detailed symptom assessment and impact Validated itch scales, quality of life measures

Appeals Playbook for New Jersey

If Cigna denies your initial request, New Jersey offers strong consumer protections through a structured appeals process.

Internal Appeals with Cigna

Level 1: Standard Internal Appeal

  • Deadline: 180 days from denial
  • Timeline: 30 days for decision (72 hours if expedited)
  • How to file: Cigna member portal or written request
  • Required: Medical necessity letter addressing specific denial reasons

Level 2: Peer-to-Peer Review Request within 24 hours of denial. Your specialist speaks directly with Cigna's medical reviewer to present:

  • Clinical severity and impact on quality of life
  • Evidence supporting Bylvay's unique mechanism for PFIC/ALGS
  • Published guidelines and clinical trial data
From our advocates: "We've seen many Bylvay denials reversed during peer-to-peer calls when the treating specialist emphasized the child's sleep disruption from severe itching and the lack of effective alternatives. Having recent clinical trial data on hand makes a significant difference in these conversations."

Clinician Corner: Medical Necessity Letter Checklist

Your specialist's letter should address:

  • Problem: Specific PFIC or ALGS diagnosis with genetic confirmation
  • Prior treatments: Detailed history of ursodeoxycholic acid and symptom-relief medications tried and failed
  • Clinical rationale: Why Bylvay's IBAT inhibition is appropriate for this patient
  • Guideline citations: Reference to FDA prescribing information and published treatment guidelines
  • Dosing: Weight-based calculation (40-120 mcg/kg daily)
  • Monitoring plan: Fat-soluble vitamin surveillance and clinical response assessment

New Jersey IHCAP External Review Process

When internal appeals fail, New Jersey's Independent Health Care Appeals Program (IHCAP) provides an independent medical review with a 68% success rate for rare disease medications.

How IHCAP Works

Administered by: Maximus Federal Services Eligibility: After completing Cigna's internal appeal process Cost: Free to patients Timeline: 45 days for standard review, 48 hours for expedited

Filing Your IHCAP Appeal

  1. Submit within 4 months of final Cigna denial
  2. Use the online portal: https://njihcap.maximus.com
  3. Required documents:
    • Final denial letter from Cigna
    • Completed external appeal form
    • All medical records and specialist letters
    • Genetic testing results

Contact Information:

  • Phone: 888-866-6205
  • Fax: 585-425-5296
  • Email: [email protected]
  • Mail: Maximus Federal-NJ IHCAP, 3750 Monroe Avenue, Suite 705, Pittsford, NY 14534
Note: IHCAP decisions are binding on insurance companies. If they overturn Cigna's denial, coverage must be provided.

Costs and Financial Assistance

Bylvay's annual cost can reach $106,000, making financial assistance crucial for most families.

Available Support Programs

Manufacturer Assistance: Contact Ipsen's patient support program through Bylvay.com

Accredo Patient Support: Automatic screening for copay cards and assistance programs during enrollment (call 877-826-7657)

Foundation Grants: Organizations like the HealthWell Foundation and Patient Access Network Foundation may provide assistance for rare disease medications

New Jersey State Programs: Low-income families may qualify for additional support through NJ FamilyCare

Getting coverage approved by insurance remains the most sustainable long-term solution, which is why Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by identifying denial reasons and crafting point-by-point rebuttals aligned with each payer's specific policies.

FAQ: Bylvay Coverage in New Jersey

How long does Cigna prior authorization take in New Jersey? Standard PA decisions take 5-10 business days if all documentation is complete. Expedited reviews for urgent cases must be completed within 72 hours.

What if Bylvay is non-formulary on my Cigna plan? You can request a formulary exception through the same PA process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal if my child's condition is worsening? Yes. Both Cigna internal appeals and New Jersey IHCAP offer expedited review for urgent medical situations where delays could cause serious harm.

Does step therapy apply if we tried treatments outside New Jersey? Treatment history from any state counts toward meeting step therapy requirements, as long as it's properly documented in medical records.

What happens if IHCAP overturns Cigna's denial? Cigna must provide coverage as directed by the IHCAP decision. This is mandated by New Jersey law (N.J.S.A. 26:2S-11).

How much does the appeals process cost? Internal appeals with Cigna and external review through IHCAP are free to patients. Insurance companies bear all costs of the review process.

Can our doctor file the IHCAP appeal for us? Yes. Healthcare providers can file external appeals on behalf of patients with written consent, which can be helpful for complex rare disease cases.

What if we're on a self-funded employer plan? Self-funded plans follow federal appeal rules rather than New Jersey's IHCAP process. Contact the plan administrator for specific procedures, though Counterforce Health can help navigate these complex appeals as well.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. For personalized guidance on your specific situation, consult with your healthcare provider and insurance company. New Jersey residents can contact the Department of Banking and Insurance Consumer Hotline at 1-800-446-7467 for additional assistance with insurance appeals.

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