By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (berotralstat) Covered by Cigna in New Jersey: Complete Appeals Guide

Answer Box: Getting Orladeyo (berotralstat) Covered by Cigna in New Jersey

Fastest path to approval: Submit prior authorization through Cigna's Express Scripts portal with HAE diagnosis confirmation (C1-INH deficiency labs), specialist prescription, and attack frequency documentation. If denied, file internal appeal within 180 days, request peer-to-peer review, then pursue New Jersey's IHCAP external review through Maximus Federal Services if needed.

First step today: Gather your C1-INH lab results, HAE attack logs, and insurance card. Contact your allergist/immunologist to initiate the Cigna prior authorization process.

Table of Contents

  1. Understanding Cigna's Orladeyo Coverage Requirements
  2. Reading Your Denial Letter
  3. Fixing Common Issues Before Appeals
  4. First-Level Internal Appeal Process
  5. Scheduling a Peer-to-Peer Review
  6. Second-Level Appeal and New Jersey External Review
  7. Appeal Letter Templates and Scripts
  8. Tracking Your Appeal Progress
  9. Cost Savings and Patient Assistance
  10. When to File a Complaint
  11. FAQ: Common Questions

Understanding Cigna's Orladeyo Coverage Requirements

Orladeyo (berotralstat) is an oral medication that prevents hereditary angioedema (HAE) attacks by inhibiting plasma kallikrein. Cigna typically covers Orladeyo through Express Scripts specialty pharmacy, but requires prior authorization with specific documentation.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization PA required before dispensing Cigna provider portal Express Scripts PA Requirements
Age Restriction Patient must be ≥12 years old FDA prescribing information Cigna Orladeyo Policy
Diagnosis Code ICD-10 D84.1 (HAE) required Medical records Cigna Medical Necessity Criteria
Lab Confirmation C1-INH deficiency documented Laboratory results Cigna Berotralstat Coverage
Specialist Prescription Allergist/immunologist required Provider credentials Cigna PA Policy
Appeals Deadline 180 days from denial Denial letter Cigna Appeals Process

Reading Your Denial Letter

When Cigna denies Orladeyo coverage, you'll receive a written denial letter within 24-48 hours. This letter contains critical information for your appeal.

Key elements to identify:

  • Denial reason code (e.g., "not medically necessary," "prior authorization required")
  • Policy number referenced (often begins with "PH" or "CNF")
  • Appeal deadline (typically 180 days for commercial plans)
  • Required documentation for reconsideration
  • Peer-to-peer contact information
Tip: Take a photo of your denial letter immediately. New Jersey law requires insurers to provide specific appeal instructions, so missing information can be grounds for complaint to the state.

Fixing Common Issues Before Appeals

Many Orladeyo denials can be resolved without formal appeals by addressing documentation gaps.

Common Denial Reasons & Quick Fixes

Denial Reason How to Fix Timeline
Missing C1-INH labs Submit functional and antigenic C1-INH levels 24-48 hours
Age verification Provide birth certificate or ID Same day
Non-specialist prescriber Transfer prescription to allergist/immunologist 1-3 days
Insufficient attack history Submit detailed attack log with dates/symptoms 24 hours
Concurrent prophylaxis Discontinue other HAE preventive medications Varies

Counterforce Health helps patients navigate these documentation requirements by automatically identifying missing elements and generating targeted appeals that address each payer's specific criteria. Their platform streamlines the process of turning denials into successful approvals by ensuring all required evidence is properly formatted and submitted. Learn more about their services.

First-Level Internal Appeal Process

If fixing documentation gaps doesn't resolve the denial, file a formal internal appeal with Cigna.

Step-by-Step: Filing Your Appeal

  1. Gather required documents (within 7 days of denial)
    • Original denial letter
    • Complete medical records showing HAE diagnosis
    • C1-INH lab results (functional <50% of normal)
    • Attack frequency logs
    • Prior treatment failures/contraindications
  2. Write your appeal letter (see templates below)
    • Address specific denial reasons
    • Include medical necessity justification
    • Cite Cigna's own coverage criteria
  3. Submit your appeal
    • Online: Cigna member portal (fastest)
    • Fax: 1-866-567-2474
    • Mail: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422
  4. Request expedited review (if applicable)
    • Call 1-800-88-CIGNA
    • State "expedited appeal request"
    • Provide 24/7 contact for peer-to-peer

Timeline: Standard appeals receive decisions within 30 days; expedited appeals within 72 hours.

Scheduling a Peer-to-Peer Review

A peer-to-peer review allows your prescribing physician to speak directly with Cigna's medical director about your case.

Clinician Corner: Preparing for Peer-to-Peer

Before the call, have ready:

  • Patient's complete HAE history
  • C1-INH lab values and dates
  • Frequency/severity of attacks
  • Prior prophylaxis attempts and outcomes
  • Contraindications to alternatives (Takhzyro, Haegarda)
  • Current attack burden and quality of life impact

Key talking points:

  • Orladeyo's FDA approval for HAE prophylaxis in patients ≥12 years
  • Patient meets Cigna's coverage criteria per policy CNF_647
  • Clinical necessity based on attack frequency and severity
  • Oral route preferred due to [specific patient factors]
From our advocates: One allergist found success by emphasizing that their patient had documented C1-INH functional levels of 15% (well below the 50% threshold) and experienced 8 attacks in the previous 6 months despite antihistamine therapy. The medical director approved coverage during the peer-to-peer call when presented with this objective data.

Second-Level Appeal and New Jersey External Review

If your first-level appeal is denied, New Jersey offers robust protections through the Independent Health Care Appeals Program (IHCAP).

New Jersey IHCAP Process

Eligibility: Available after completing Cigna's internal appeal process for medical necessity denials.

How to file:

  • Online: njihcap.maximus.com
  • Phone: 888-866-6205
  • Mail: Maximus Federal Services, Attn: State Appeals/NJ IHCAP, 3750 Monroe Avenue, Suite 705, Pittsford, NY 14534

Timeline:

  • Standard review: Decision within 45 days
  • Expedited review: Decision within 48 hours (for urgent cases)
  • Filing deadline: 4 months from final internal denial

Required documents:

  • Completed external appeal application
  • Consent and authorization forms
  • Cigna's internal appeal decision letters
  • All supporting medical records

Cost: $25 filing fee (may be waived for financial hardship)

Note: IHCAP decisions are binding on insurers. If the independent medical reviewers determine Orladeyo is medically necessary, Cigna must provide coverage.

Appeal Letter Templates and Scripts

Medical Necessity Appeal Letter Template

[Date]

Cigna National Appeals Unit
P.O. Box 188011
Chattanooga, TN 37422

Re: Appeal for Coverage of Orladeyo (berotralstat)
Member: [Name]
Member ID: [ID Number]
Claim/Service Number: [Number]
Date of Denial: [Date]

Dear Appeals Review Team:

I am formally appealing Cigna's denial of coverage for Orladeyo (berotralstat) dated [date]. This medication is medically necessary for the prophylactic treatment of hereditary angioedema (HAE) in accordance with Cigna's own coverage criteria outlined in policy CNF_647.

PATIENT MEETS ALL COVERAGE CRITERIA:

1. Confirmed HAE Diagnosis (ICD-10 D84.1): Laboratory results show C1-INH functional level of [X]% (normal >50%), confirming HAE Type I/II diagnosis.

2. Age Requirement: Patient is [X] years old, meeting the ≥12 years requirement.

3. Specialist Prescription: Prescribed by Dr. [Name], board-certified allergist/immunologist.

4. Medical Necessity: Patient experiences [X] HAE attacks per month despite standard care, significantly impacting quality of life and requiring prophylactic therapy.

5. Prior Treatment Considerations: [Detail any previous therapies tried, failed, or contraindicated]

SUPPORTING EVIDENCE:
- C1-INH laboratory results dated [date]
- Attack frequency logs
- Clinical notes from allergist
- FDA prescribing information confirming indication

This appeal is submitted within the 180-day deadline. I am available for peer-to-peer review at [phone] or [email].

Sincerely,
[Prescriber Name and Credentials]

Patient Phone Script for Cigna

"Hello, I'm calling about my Orladeyo prior authorization denial. My member ID is [X]. I'd like to request a peer-to-peer review between my doctor and your medical director, and I need information about filing an internal appeal. Can you also confirm the exact deadline for my appeal and provide the fastest way to submit additional documentation?"

Tracking Your Appeal Progress

Appeal Timeline Tracker

Stage Expected Timeline Action Required Status
PA Submission 3-5 business days Submit complete documentation ☐
Initial Decision 15 days (standard) None ☐
First Appeal 30 days Submit appeal letter + evidence ☐
Peer-to-Peer 1-2 business days Physician availability ☐
Second Appeal 30 days Additional documentation if needed ☐
External Review 45 days File with IHCAP ☐

Escalation triggers:

  • No response within stated timeframes
  • Request for already-submitted documentation
  • Denial without clear medical rationale

Cost Savings and Patient Assistance

Orladeyo's wholesale acquisition cost is approximately $44,484 per 28-day supply as of January 2025. Several programs can reduce out-of-pocket costs:

Manufacturer Support:

  • BioCryst Patient Access Program
  • Copay assistance for commercially insured patients
  • Free drug program for uninsured/underinsured patients

Foundation Assistance:

  • Chronic Disease Fund
  • HealthWell Foundation
  • Patient Access Network Foundation

New Jersey State Programs:

  • NJ FamilyCare (Medicaid expansion)
  • Pharmaceutical Assistance to the Aged and Disabled (PAAD)

Counterforce Health's platform also helps identify these cost-saving opportunities while building your coverage appeal, ensuring you're aware of all available financial assistance options during the approval process.

When to File a Complaint

File a complaint with New Jersey regulators if Cigna:

  • Fails to respond within required timeframes
  • Requests already-submitted documentation repeatedly
  • Denies coverage without clear medical rationale
  • Violates New Jersey insurance regulations

New Jersey Department of Banking and Insurance:

  • Phone: 1-800-446-7467
  • Online: nj.gov/dobi
  • IHCAP Hotline: 1-888-393-1062

FAQ: Common Questions

Q: How long does Cigna prior authorization take in New Jersey? A: Standard PA decisions are issued within 15 days; expedited requests within 72 hours. New Jersey law requires timely processing.

Q: What if Orladeyo isn't on Cigna's formulary? A: Request a formulary exception by demonstrating medical necessity and providing clinical justification for this specific medication over alternatives.

Q: Can I get expedited appeal review? A: Yes, if delay would seriously jeopardize your health. Call 1-800-88-CIGNA and request expedited review with supporting physician documentation.

Q: Does step therapy apply to Orladeyo? A: Cigna may require trial of other HAE prophylaxis medications first. Document failures, contraindications, or intolerance to bypass step therapy.

Q: What happens if my external appeal fails? A: Consider formulary alternatives, manufacturer patient assistance programs, or consultation with HAE advocacy organizations for additional resources.

Q: How much does the New Jersey external review cost? A: $25 filing fee, which may be waived for financial hardship. Cigna pays all other review costs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Appeal processes and requirements may change; verify current procedures with your insurer and state regulators.

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