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

How to Get Takhzyro (lanadelumab-flyo) Covered by Cigna in Virginia: Complete Appeal Guide with Forms and Timelines

Quick Answer: Getting Takhzyro Covered by Cigna in Virginia

Cigna requires prior authorization for Takhzyro (lanadelumab-flyo) with confirmed HAE type I/II diagnosis, low C1-INH and C4 labs, and specialist prescription. If denied, you have 180 days to appeal internally, then 120 days for Virginia's free external review via Form 216-A through the State Corporation Commission Bureau of Insurance. Start today: Gather your attack logs, lab results (C1-INH functional <50%, low C4), and have your allergist/immunologist submit a medical necessity letter citing the HELP study's 73% attack reduction data.

Table of Contents

Read the Denial Letter

When Cigna denies Takhzyro, your denial letter will typically cite one of these reasons:

  • "Prior authorization required" - You need PA approval before filling
  • "Not medically necessary" - Clinical criteria weren't met
  • "Experimental/investigational" - Incorrect; Takhzyro has FDA approval for HAE prophylaxis
  • "Step therapy required" - Must try other HAE medications first
  • "Non-formulary" - Drug isn't on Cigna's preferred list
Note: Cigna manages specialty drugs like Takhzyro through Express Scripts and Accredo specialty pharmacy. Your denial may come from either entity.

Key deadline: You have 180 days from the denial notice to file your first internal appeal with Cigna.

Cigna's Takhzyro Requirements

Based on Cigna's official policy, approval requires:

Requirement What Cigna Needs Where to Get It
HAE Diagnosis Confirmed type I or II (not type III) Genetic testing or family history
Lab Confirmation C1-INH functional <50% normal + low C4 Recent bloodwork from your specialist
Specialist Prescription Allergist/immunologist or HAE specialist Referral if needed
Attack Documentation Frequency, severity, impact on daily life Attack diary or medical records
Age Requirement Patient ≥2 years old Birth certificate/medical records

Reauthorization: Cigna requires annual renewal with evidence of reduced attack frequency or severity compared to baseline.

Fixable Causes Before Appealing

Before filing an appeal, check if these quick fixes apply:

Missing Documentation:

  • Submit complete lab results (both C1-INH functional and C4 levels)
  • Provide specialist consultation notes
  • Include attack frequency logs from the past 6 months

Coding Issues:

  • Ensure your doctor used correct diagnosis codes for HAE type I (D84.1) or type II
  • Verify Takhzyro's NDC codes match your prescription

Benefit vs. Medical Policy:

  • Confirm Takhzyro coverage under your specific Cigna plan
  • Check if you need specialty pharmacy enrollment through Accredo

First-Level Internal Appeal

What to Include in Your Appeal

Required Documents:

  1. Completed appeal form - Use Cigna's member appeal form or provider form
  2. Original denial letter - Include all pages and reference numbers
  3. Medical necessity letter from your specialist (see template below)
  4. Clinical evidence - Attack logs, lab results, prior treatment failures
  5. FDA labeling - Takhzyro prescribing information showing HAE indication

Medical Necessity Letter Checklist

Your allergist/immunologist should include:

  • Patient diagnosis: HAE type I/II with specific lab values
  • Attack history: Baseline frequency, severity, impact on quality of life
  • Prior treatments: What you've tried and why they failed or weren't tolerated
  • Clinical rationale: Why Takhzyro is medically necessary for your case
  • Evidence citations: Reference the HELP study showing 73% attack reduction
  • Treatment plan: Proposed dosing schedule and monitoring approach

Timeline and Submission

  • Deadline: 180 days from denial notice
  • Decision time: 30 days for pre-service appeals, 60 days for post-service
  • How to submit: Cigna member portal, fax, or mail (verify current contact info)

Peer-to-Peer Review Strategy

If your first appeal is denied, request a peer-to-peer review with Cigna's medical director before filing your second-level appeal.

Preparation checklist:

  • Have your attack diary ready with specific dates and severity scores
  • Prepare talking points about functional impairment (missed work/school, ER visits)
  • Reference 2020 HAEA Guidelines recommending Takhzyro as first-line prophylaxis
  • Emphasize patient-specific factors that make alternatives unsuitable

Key message: "This patient has confirmed HAE type [I/II] with documented attacks averaging [X] per month, significantly impacting their ability to [work/attend school/care for family]. The HELP study demonstrates Takhzyro's superior efficacy, and current guidelines support its use as first-line prophylaxis."

Second-Level Appeal & Virginia External Review

Internal Level 2 Appeal

  • Deadline: 60 days after first-level denial
  • Process: Independent medical review by different Cigna physician
  • Timeline: 30-45 days for decision

Virginia External Review (Form 216-A)

If Cigna denies your second internal appeal, Virginia offers free, binding external review through the State Corporation Commission Bureau of Insurance.

Eligibility:

  • Completed Cigna's internal appeals process (or eligible for expedited review)
  • Denial based on medical necessity, experimental treatment, or similar clinical judgment
  • Virginia-issued plan or self-funded plan that opted into Virginia's process

How to File:

  1. Download Form 216-A (External Review Request) from the SCC website
  2. Complete all sections including patient demographics and denial details
  3. Attach: final denial letter, medical records, provider support letter
  4. Mail to: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218

Timeline:

  • Filing deadline: 120 days from final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours if delay could jeopardize health
Virginia Advantage: The Bureau of Insurance encourages you to call 1-877-310-6560 before filing to ensure you have all required documents and understand the process.

If You Win: Cigna must authorize coverage within 24 hours (expedited) or 1-3 days (standard).

Appeal Letter Template

Here's a framework for your medical necessity letter:

RE: Prior Authorization Appeal for Takhzyro (lanadelumab-flyo) Patient: [Name], DOB: [Date], Policy: [Number] Denial Date: [Date], Reference: [Denial number]

Dear Cigna Medical Director,

I am writing to appeal the denial of Takhzyro (lanadelumab-flyo) for my patient with confirmed hereditary angioedema type [I/II]. This medication is medically necessary and supported by FDA approval and clinical guidelines.

Patient History:

  • Confirmed HAE type [I/II] with C1-INH functional level of [X]% (normal >50%) and C4 level of [X] mg/dL (low)
  • Baseline attack frequency: [X] attacks per month over the past 6 months
  • Prior treatments tried: [List medications and outcomes/failures]
  • Functional impact: [Missed work days, ER visits, quality of life effects]

Clinical Evidence: The HELP study (n=125) demonstrated Takhzyro 300mg every 4 weeks reduced HAE attacks by 73% compared to placebo (p<0.001). The 2020 HAEA Guidelines recommend Takhzyro as first-line prophylaxis for patients ≥12 years.

Medical Necessity: This patient meets all Cigna criteria: confirmed HAE diagnosis, documented attacks, specialist prescription, and age ≥2 years. Takhzyro is FDA-approved for exactly this indication and is considered standard of care.

Request: Please approve Takhzyro 300mg subcutaneous injection every 4 weeks for HAE prophylaxis.

Sincerely, [Physician name and credentials]

Costs & Patient Assistance

Takhzyro costs approximately $26,353 per 300mg vial. Even with insurance, your out-of-pocket costs may be substantial.

Financial assistance options:

  • Takeda Patient Assistance Program - Income-based free drug program
  • Commercial copay card - May reduce copays to $10-25 per month (eligibility restrictions apply)
  • State pharmaceutical assistance programs - Virginia may offer additional support
From our advocates: We've seen patients successfully combine manufacturer assistance with insurance coverage to reduce monthly costs from over $1,000 to under $50. The key is applying for all available programs simultaneously and working with your specialty pharmacy to coordinate benefits.

When to Escalate in Virginia

Contact Virginia regulators if:

  • Cigna misses appeal deadlines (30-60 days)
  • You're denied expedited review for urgent situations
  • The insurer doesn't comply with an external review decision

Virginia State Corporation Commission Bureau of Insurance

  • Phone: 1-877-310-6560
  • Email: [email protected]
  • Online complaint form available on SCC website

Virginia Office of the Managed Care Ombudsman

  • Same phone number as above
  • Specializes in HMO and managed care plan issues
  • Can sometimes resolve disputes informally

Frequently Asked Questions

How long does Cigna prior authorization take for Takhzyro in Virginia? Standard review takes 5-15 business days. Expedited review (for urgent cases) takes 24-72 hours. Source: Cigna PA policy

What if Takhzyro isn't on my Cigna formulary? You can request a formulary exception with clinical justification. This requires demonstrating medical necessity and often that preferred alternatives aren't suitable.

Can I get expedited appeals in Virginia? Yes, if your doctor certifies that waiting could seriously jeopardize your health. Virginia allows expedited external review in 72 hours for urgent medical necessity denials.

Does step therapy apply to Takhzyro? Cigna's 2024 formulary doesn't specify step therapy requirements for Takhzyro initial HAE prophylaxis, but individual plans may vary.

What counts as adequate attack documentation? Most payers want evidence of ≥1 attack per month over 6 months, with details about location (facial, abdominal, laryngeal), severity, and duration. Keep a detailed attack diary.

How successful are Takhzyro appeals? While specific success rates aren't published, Cigna members appeal PA denials at higher rates (~18%) than other payers, suggesting many initial denials are overturned with proper clinical evidence.

Need help navigating this process? Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes your denial letter and plan policy, then drafts point-by-point rebuttals aligned to your payer's specific requirements, pulling the right clinical evidence and procedural details to maximize your chances of approval.

Whether you're facing a prior authorization denial, quantity limit, or "not medically necessary" determination, having expert support can make the difference between paying out-of-pocket and getting your HAE treatment covered. Learn more about Counterforce Health's appeal services.

Sources & Further Reading

Disclaimer: This article provides general information about insurance appeals and is not medical advice. Consult your healthcare provider for medical decisions and verify current policy details with your insurer. Appeal processes and requirements may change; always check official sources for the most current information.

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