By Counterforce Health Team in Bylvay (odevixibat) —

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

Answer Box: Get Bylvay (Odevixibat) Covered by Cigna in California

Cigna requires prior authorization for Bylvay (odevixibat) for PFIC and Alagille syndrome patients. To get approved: (1) Submit PA through your specialist with genetic testing, treatment history, and weight-based dosing documentation via Accredo specialty pharmacy, (2) If denied, file internal appeal within 180 days, then (3) Request California DMHC Independent Medical Review within 6 months for binding decision. Success rates for specialty drug IMRs range 35-60% in California.

Start today: Contact your hepatologist to initiate the prior authorization through Cigna's ExpressPAth portal.

Table of Contents

Cigna's Coverage Policy Overview

Cigna covers Bylvay (odevixibat) across HMO, PPO, and Medicare Advantage plans in California, but prior authorization is always required. The drug is classified as non-preferred specialty with limited distribution, meaning you'll need comprehensive documentation and must use Accredo specialty pharmacy.

Key Policy Details:

  • Formulary Status: Non-preferred, prior authorization required
  • Specialty Pharmacy: Must use Express Scripts/Accredo
  • Review Timeline: 5-10 business days (standard), 24-72 hours (expedited)
  • Appeal Rights: Internal appeals within 180 days, then California IMR
Note: Self-funded employer plans may follow different timelines but typically adopt similar clinical criteria.

FDA Indication Requirements

Bylvay is FDA-approved for two specific conditions with age restrictions:

Progressive Familial Intrahepatic Cholestasis (PFIC):

  • Patients ≥3 months old
  • Treatment of cholestatic pruritus
  • ICD-10: K83.1 (Obstruction of bile duct)

Alagille Syndrome:

  • Patients ≥12 months old
  • Treatment of cholestatic pruritus
  • ICD-10: Q44.7 (Other congenital malformations of liver)

Off-Label Considerations: Cigna may deny coverage for other cholestatic conditions. If prescribing off-label, you'll need compelling evidence that FDA-approved alternatives are inappropriate and that medical literature supports Bylvay's use.

Step Therapy & Medical Exceptions

Cigna typically requires documentation of failure or intolerance to conventional therapies before approving Bylvay:

Required Prior Treatments:

  • Ursodeoxycholic acid (UDCA)
  • Cholestyramine or colesevelam
  • Rifampin (for pruritus management)
  • Antihistamines for symptomatic relief

Medical Exception Pathways:

  • Contraindications: Document why standard therapies are medically inappropriate
  • Previous Intolerance: Provide specific adverse reactions and dates
  • Clinical Urgency: Severe pruritus impacting quality of life despite standard care

Documentation Required:

  • Medication trial dates and durations
  • Specific reasons for discontinuation
  • Current symptom severity scores
  • Physician attestation of medical necessity

Quantity Limits & Weight-Based Dosing

Bylvay dosing is strictly weight-based, and Cigna will verify appropriate dosing before approval:

PFIC Dosing:

  • Starting: 40 mcg/kg once daily
  • Maximum: 120 mcg/kg/day (not exceeding 6 mg/day)
  • Escalation: 40 mcg/kg increments after 3 months if needed

Alagille Syndrome Dosing:

  • Starting: 120 mcg/kg once daily
  • Maximum: 7.2 mg/day
  • Reduction: 40 mcg/kg/day for tolerability issues

Formulation Selection:

  • Oral pellets: Patients <19.5 kg
  • Capsules: Patients ≥19.5 kg

Quantity Limits: Cigna typically approves 30-day supplies with refills based on demonstrated clinical response and adherence to monitoring requirements.

Required Diagnostics & Lab Values

Baseline Requirements:

  • Genetic Testing: Confirmed mutations (PFIC: ATP8B1, ABCB11, TJP2; Alagille: JAG1, NOTCH2)
  • Liver Function Tests: ALT, AST, bilirubin, alkaline phosphatase, GGT
  • Serum Bile Acids: Elevated levels (≥100 µmol/L for PFIC)
  • Fat-Soluble Vitamins: Levels to document deficiency

Ongoing Monitoring:

  • Monthly LFTs during initiation
  • Every 2-3 months once stable
  • Pruritus severity assessments
  • Growth parameters (pediatric patients)

Documentation Tips:

  • Include reference ranges for pediatric values
  • Note trends over time, not just single values
  • Document relationship between lab values and symptoms

Specialty Pharmacy Requirements

Accredo Dispensing: All Bylvay prescriptions must be filled through Express Scripts' Accredo specialty pharmacy. Your prescriber will need to:

  1. Submit PA electronically via ExpressPAth portal
  2. Provide clinical documentation supporting medical necessity
  3. Coordinate patient enrollment with Accredo for delivery
  4. Monitor ongoing therapy with required lab work

Patient Responsibilities:

  • Complete Accredo enrollment process
  • Provide insurance and contact information
  • Coordinate delivery timing
  • Maintain regular specialist follow-ups

Accredo Contact: 888-302-1028 (verify current number with your plan)

Evidence for Medical Necessity

Clinical Guidelines to Reference:

  • FDA prescribing information for Bylvay
  • AASLD Practice Guidelines for cholestatic liver disease
  • NASPGHAN position papers on pediatric cholestasis
  • European Society for Pediatric Gastroenterology guidelines

Peer-Reviewed Evidence:

  • Phase 3 trial data (PEDFIC 1 and 2 studies)
  • Real-world evidence studies
  • Comparative effectiveness research vs. other IBAT inhibitors

Documentation Strategy:

  • Cite specific guideline recommendations
  • Include abstracts of key studies
  • Reference FDA approval rationale
  • Document patient-specific factors supporting use
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and drafting point-by-point rebuttals aligned to each plan's own rules.

Sample Medical Necessity Letter

Essential Elements:

  1. Patient Demographics: Age, weight, diagnosis with ICD-10
  2. Clinical History: Symptom onset, previous treatments, current severity
  3. Diagnostic Confirmation: Genetic testing results, lab values
  4. Treatment Rationale: Why Bylvay is appropriate, dosing justification
  5. Monitoring Plan: Follow-up schedule, safety assessments

Template Structure: "[Patient] is a [age]-year-old with genetically confirmed [PFIC/Alagille syndrome] experiencing moderate-to-severe cholestatic pruritus despite treatment with [list prior therapies and outcomes]. Genetic testing revealed [specific mutation]. Current serum bile acids are [value] µmol/L. Based on FDA approval for this indication and [cite guidelines], Bylvay at [dose] mcg/kg daily is medically necessary. I will monitor with monthly LFTs and pruritus assessments."

Common Denial Reasons & Solutions

Denial Reason Solution
Age below threshold Verify patient meets minimum age (3 months PFIC, 12 months Alagille)
Lack of genetic confirmation Submit genetic testing results showing pathogenic variants
Insufficient prior therapy Document specific trials of UDCA, cholestyramine, rifampin with dates/outcomes
Off-label use Provide compelling literature for non-FDA approved cholestatic conditions
Dosing concerns Include weight-based calculations with pediatric dosing references
Non-formulary status Request formulary exception with clinical justification

California Appeals Process

Internal Appeal (Required First Step):

  • Deadline: 180 days from denial
  • Method: Written request to Cigna member services
  • Timeline: 30 days for standard, 72 hours for expedited
  • Documents: Denial letter, medical records, physician letter

Independent Medical Review (IMR):

  • When: After internal appeal denial or 30 days without response
  • Deadline: 6 months from final internal decision
  • Process: File with California DMHC at 888-466-2219
  • Timeline: 30-45 days standard, 7 days expedited
  • Cost: Free to patients
  • Success Rate: 35-60% for specialty drugs

Required IMR Documentation:

  • Complete medical records
  • Denial letters from Cigna
  • Physician statement of medical necessity
  • Relevant clinical guidelines and studies
  • Patient impact statement

California's IMR process has binding authority over Cigna—if the independent medical reviewer determines Bylvay is medically necessary, Cigna must authorize coverage.

Costs & Patient Assistance

Bylvay Pricing:

  • $14,152–$44,562 per 30 capsules (depending on strength)
  • Annual costs can exceed $100,000

Patient Assistance Options:

  • Ipsen Cares: Manufacturer copay assistance program
  • Foundation Support: Patient Advocate Foundation, HealthWell Foundation
  • California Programs: Medi-Cal coverage for eligible patients

Insurance Strategy: Even with high costs, California's consumer protections and IMR success rates make appeals worthwhile. Counterforce Health helps patients and clinicians navigate the appeal process by providing targeted, evidence-backed documentation that addresses each plan's specific requirements.

FAQ

How long does Cigna prior authorization take in California? Standard reviews take 5-10 business days. Expedited reviews for urgent cases are completed within 24-72 hours.

What if Bylvay is not on my Cigna formulary? Request a formulary exception with clinical justification. If denied, this can be appealed through California's IMR process.

Can I request an expedited appeal? Yes, if delays pose serious health risks. Both Cigna internal appeals and California IMR offer expedited pathways.

Does step therapy apply if I failed treatments in another state? Document all prior treatments regardless of location. Cigna should accept properly documented treatment failures from any provider.

What happens if I miss the appeal deadline? California allows 6 months for IMR filing after internal appeals. Contact DMHC immediately if you're approaching deadlines.

How much does the California appeals process cost? IMR is free to patients. Cigna pays all review costs, and there are no filing fees.

From our advocates: We've seen families successfully overturn Bylvay denials by focusing on three key elements: comprehensive genetic testing documentation, detailed pruritus severity tracking with validated scales, and clear evidence that conventional therapies were inadequate. The combination of strong clinical documentation and California's patient-friendly IMR process creates favorable odds for approval.

Disclaimer: This information is for educational purposes only and is not medical or legal advice. Insurance policies and state regulations can change. Always consult with your healthcare provider and verify current requirements with Cigna and California regulators.

For personalized assistance with complex prior authorization cases, Counterforce Health provides specialized support in converting insurance denials into successful appeals through evidence-based documentation and payer-specific strategies.

Sources & Further Reading

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