By Counterforce Health Team in Takhzyro (lanadelumab-flyo) —

Complete Guide to Getting Takhzyro (lanadelumab-flyo) Approved by Cigna in Texas: Requirements, Appeals, and Timelines

Answer Box: Getting Takhzyro Approved by Cigna in Texas

Cigna requires prior authorization for Takhzyro (lanadelumab-flyo) with confirmed HAE type I/II diagnosis, low C1-INH levels (<50% normal), and low C4 levels. Submit through your HAE specialist with lab documentation, attack logs, and medical necessity letter via Cigna's provider portal. Standard approval takes 5-15 business days; expedited review available for urgent cases (24-72 hours). If denied, Texas residents can appeal through Cigna's internal process (180 days) then request binding external review through the Texas Department of Insurance at no cost.

First step today: Contact an in-network allergist/immunologist to schedule HAE diagnostic testing and begin the prior authorization process.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Required Documentation Package
  5. Coding and Billing Information
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: Tracking and Follow-up
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in Texas
  11. Cost-Saving Options
  12. FAQ

Who Should Use This Guide

This guide is designed for Texas residents with Cigna insurance who need Takhzyro (lanadelumab-flyo) for hereditary angioedema (HAE) prophylaxis, along with their healthcare providers. You'll find this most helpful if you:

  • Have confirmed or suspected HAE type I or II
  • Are experiencing frequent HAE attacks (typically ≥1 per month)
  • Have tried other HAE treatments with inadequate response
  • Received a Cigna denial and need appeal guidance

Expected outcome: With proper documentation, initial approvals occur in 60-70% of cases. Appeals have higher success rates (70-78% nationally) when supported by complete clinical evidence.

Member & Plan Basics

Coverage Requirements

  • Active Cigna coverage with prescription benefits
  • In-network HAE specialist (allergist/immunologist) required for prescription
  • Prior authorization mandatory for all Takhzyro prescriptions
  • Specialty pharmacy dispensing through Accredo (Cigna's designated vendor)

Plan Type Considerations

Plan Type Key Requirements Notes
HMO PCP referral to specialist Must obtain referral before specialist visit
PPO Direct specialist access Can schedule directly with in-network provider
Medicare Advantage Follow Medicare PA rules 65-day appeal deadline vs. 180 days commercial

Clinical Criteria for Approval

Cigna requires all of the following criteria to be met for Takhzyro approval:

Primary Diagnostic Requirements

  1. Confirmed HAE type I or II diagnosis (type III excluded)
  2. Low functional C1-INH protein (<50% of normal) documented by lab testing
  3. Low serum C4 levels at baseline
  4. Prescription by or in consultation with allergist/immunologist or HAE specialist

Clinical Documentation Needed

  • Attack frequency and severity logs
  • Prior therapy outcomes (if applicable)
  • Family history of HAE (present in 75% of cases)
  • Response to previous treatments
Note: Cigna's policies (CNF_406 and IP_0334) do not mandate step therapy, but prior treatment history strengthens applications.

Required Documentation Package

Lab Results (Essential)

  • C1-INH functional levels (measured by ELISA)
  • C1-INH antigenic levels (measured by nephelometry)
  • C4 levels (screening test - invariably low in untreated HAE)
  • C1q levels (to rule out acquired angioedema)

Medical Records

  • HAE diagnosis confirmation notes
  • Attack logs with dates, locations, duration, and severity
  • Prior therapy documentation (medications tried, outcomes, reasons for discontinuation)
  • Family history documentation

Medical Necessity Letter Components

Your specialist should include these elements in their letter:

  1. Patient identification and confirmed HAE type I/II diagnosis
  2. Laboratory evidence with specific values and reference ranges
  3. Attack frequency/severity with impact on quality of life
  4. Prior therapies attempted and clinical outcomes
  5. Treatment goals and expected benefits of Takhzyro
  6. FDA labeling reference for approved indication
  7. Dosing plan and monitoring approach

Coding and Billing Information

Key Medical Codes

Code Type Code Description
ICD-10 D84.1 Deficiencies in enzymes other than lipase (HAE)
HCPCS J0593 Injection, lanadelumab-flyo, 1 mg
CPT 96372 Therapeutic/prophylactic/diagnostic injection

NDC Codes (Takeda-manufactured)

  • 47783-0644-01: 300 mg vial
  • 47783-0645-01: 150 mg vial
  • 47783-0646-01: 300 mg vial

Billing Notes

  • Medicare payment limit: $87.284 per mg
  • Maximum dosing: 300 mg per 14 days for prophylaxis
  • Prior authorization required for initial 12 months, renewable annually

Submission Process

Step-by-Step Submission

  1. Specialist gathers documentation (labs, attack logs, medical necessity letter)
  2. Submit via Cigna provider portal or fax to number specified in denial letter
  3. Include all required forms and supporting documentation
  4. Request expedited review if urgent (severe/frequent attacks)
  5. Obtain confirmation number and track submission status

Timeline Expectations

Review Type Timeline Notes
Standard PA 5-15 business days Includes decision or request for additional information
Expedited PA 24-72 hours For urgent cases with severe attacks
Formulary exception 72 hours (non-urgent) Auto-approval if no response within timeframe

Specialty Pharmacy Routing

Upon Cigna approval, prescriptions automatically route to Accredo, Cigna's designated specialty pharmacy for Takhzyro.

Accredo Contact Information

  • Phone: 877-826-7657
  • Hours: Mon-Fri 7am-10pm CST, Sat 7am-4pm CST
  • Services: Home delivery, injection training, adherence support

Enrollment Process

  1. Accredo contacts patient within 24-48 hours of approval
  2. Schedule first fill (typically 3-5 business days)
  3. Injection training provided via phone or video
  4. Ongoing support for refills and clinical monitoring
Tip: Takeda offers a Quick Start Program for commercially insured patients 12+ to provide free medication during PA processing. Call 1-866-888-0660.

After Submission: Tracking and Follow-up

What to Track

  • Confirmation number from submission
  • Review timeline based on standard vs. expedited
  • Additional information requests from Cigna
  • Decision notification method (portal, mail, phone)

Status Check Schedule

  • Day 3: Confirm receipt via provider portal
  • Day 7: Check for additional information requests
  • Day 10: Follow up if no response to standard review
  • Day 15: Escalate if approaching deadline

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
No confirmed HAE diagnosis Submit complete lab panel C1-INH functional, antigenic, C4, C1q levels
Insufficient attack documentation Provide detailed attack logs Dates, locations, duration, severity, triggers
Missing specialist involvement Get allergist/immunologist consultation Specialist evaluation and prescription
Incomplete medical necessity Enhance clinical justification Treatment goals, prior therapy failures, quality of life impact

Appeals Process in Texas

When dealing with prescription drug coverage, many Texans face the frustrating experience of insurance denials. Counterforce Health specializes in turning these denials into successful appeals by analyzing the specific denial reasons and crafting targeted, evidence-backed rebuttals that align with each insurer's own policies and procedures.

Texas-Specific Appeal Rights

Texas residents have strong appeal rights under state law, including access to independent external review at no cost.

Appeal Timeline

Level Deadline Review Time Notes
Level 1 Internal 180 days from denial 30 days (pre-service), 60 days (post-service) Different medical reviewer
Level 2 Internal 60 days from Level 1 denial 30-60 days Optional but recommended
Texas IRO External 4 months from final denial 20 days standard, 5 days urgent Binding decision, free to consumer

How to Appeal

  1. Contact Cigna Customer Service at 1-800-88CIGNA to discuss denial
  2. Submit written appeal to Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422
  3. Include enhanced documentation addressing specific denial reasons
  4. Request peer-to-peer review with Cigna medical director
  5. File Texas IRO request if internal appeals denied (online at tdi.texas.gov)

Medical Necessity Appeal Letter Template

Use this structure on physician letterhead:

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

Re: Appeal of Denial - Claim #[ID] - Member [Name, DOB]

1. Patient/Claim Details: [Full identification information]
2. Denial Summary: [Exact reason from EOB/letter]
3. Medical Necessity Justification: [Reference specific Cigna policy criteria]
4. Supporting Evidence: [List all attachments]
5. Timeline Compliance: [Confirm within 180 days]
6. Requested Relief: [Specific approval request]
7. Physician Attestation: [Medical necessity confirmation]

[Physician signature and credentials]

Cost-Saving Options

Manufacturer Support

  • Takhzyro Quick Start Program: Free medication during PA review for eligible patients
  • Patient assistance programs: Available through Takeda
  • Copay assistance: May reduce out-of-pocket costs

Additional Resources

  • State pharmacy assistance programs (verify current Texas offerings)
  • Nonprofit foundation grants for rare disease treatments
  • Clinical trial opportunities through HAE research centers

FAQ

Q: How long does Cigna prior authorization take for Takhzyro in Texas? A: Standard review takes 5-15 business days. Expedited review for urgent cases takes 24-72 hours.

Q: What if Takhzyro is non-formulary on my Cigna plan? A: You can request a formulary exception with clinical justification. Cigna must respond within 72 hours for non-urgent requests.

Q: Can I request an expedited appeal in Texas? A: Yes, both Cigna internal appeals and Texas IRO external review offer expedited processes for urgent medical situations.

Q: Does step therapy apply if I've tried HAE medications outside of Texas? A: Prior therapy documentation from any location is relevant. Cigna doesn't require specific step therapy for Takhzyro, but prior treatment history strengthens applications.

Q: What happens if my appeal is denied? A: Texas residents can request independent external review through the Texas Department of Insurance. This review is binding on Cigna and free to consumers.

Q: Who can prescribe Takhzyro for HAE? A: Cigna requires prescription by or in consultation with an allergist/immunologist or HAE specialist.

From our advocates: We've seen cases where patients initially received denials for "insufficient attack documentation" but succeeded on appeal after providing detailed attack logs spanning 6-12 months. The key was showing not just frequency but also the impact on work, school, and daily activities. While outcomes vary by individual case, thorough documentation consistently improves approval chances.

For complex cases requiring detailed appeal strategy, Counterforce Health offers specialized expertise in transforming insurance denials into successful approvals through evidence-based appeals that speak directly to insurers' own coverage criteria and medical policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For assistance with Texas insurance appeals, contact the Texas Department of Insurance at 1-800-252-3439.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.