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

How to Get Takhzyro (lanadelumab-flyo) Covered by Aetna (CVS Health) in New York: Appeals Guide and State Protections

Answer Box: Quick Path to Coverage

Getting Takhzyro (lanadelumab-flyo) covered by Aetna (CVS Health) in New York requires prior authorization and meeting specific HAE criteria. Start with your doctor submitting a PA request through CVS Caremark's provider portal, including confirmed HAE type I/II diagnosis (C4/C1-INH labs), documented attack history, and evidence of inadequate response to other prophylaxis. If denied, you have 180 days to appeal internally, with decisions in 30-45 days (72 hours if expedited). After final internal denial, file an external appeal with New York's Department of Financial Services within 4 months—decisions in 72 hours for urgent cases or 30 days standard. File external appeals here.

Table of Contents

  1. Why New York State Rules Matter
  2. Aetna (CVS Health) Coverage Requirements
  3. New York Appeal Turnaround Standards
  4. Step Therapy Protections (Effective 2026)
  5. External Review Process
  6. Practical Appeals Scripts
  7. When to Escalate Beyond Aetna
  8. Common Denial Reasons & Solutions
  9. FAQ
  10. Sources & Further Reading

Why New York State Rules Matter

New York's robust insurance regulations provide multiple layers of protection for patients seeking coverage for specialty medications like Takhzyro (lanadelumab-flyo). Unlike many states, New York requires specific turnaround times for prior authorization decisions and offers one of the nation's most comprehensive external appeal processes.

Key advantages for New York patients:

  • Binding external appeals through the Department of Financial Services with independent medical review
  • Expedited timelines for urgent cases (24-72 hours vs. weeks elsewhere)
  • Strong step therapy protections beginning January 1, 2026
  • Consumer assistance through Community Health Advocates at (888) 614-5400

These protections apply to fully-insured commercial plans, marketplace plans, and Medicaid managed care—but not self-funded employer plans (ERISA), which follow federal rules only.

Aetna (CVS Health) Coverage Requirements

Coverage Status and Formulary Placement

Takhzyro appears as a Tier 3-5 specialty medication on Aetna Medicare Comprehensive Plus formularies, requiring prior authorization with age restrictions and additional clinical support. The standard quantity limit is 2 mL per 28 days.

For non-Medicare Aetna plans, Takhzyro may appear on exclusion lists with preferred alternatives like Cinryze or Orladeyo, meaning coverage requires demonstrating that preferred options are not clinically appropriate.

Prior Authorization Criteria

Aetna's approval criteria for Takhzyro typically include:

Requirement Documentation Needed Source
Confirmed HAE diagnosis C4 complement level, C1-INH functional assay, genetic testing Aetna SGM Policy
Attack frequency Documentation of ≥1 attack/month despite standard care Clinical notes, attack diary
Age requirement ≥2 years old FDA indication
Previous therapy Trial/failure of or contraindication to Cinryze, Haegarda, or Orladeyo Medical records, prior auth history
Counterforce Health helps patients navigate these complex approval requirements by analyzing denial letters and plan policies to create targeted, evidence-backed appeals that address each specific criterion. Learn more about our approach.

New York Appeal Turnaround Standards

Internal Appeals Timeline

For Aetna Better Health NY (Medicaid):

  • Standard appeals: Decision within 30 calendar days
  • Urgent/expedited appeals: Decision within 48-72 hours
  • Continuation of services: Request within 10 days to maintain coverage during appeal

For Commercial Aetna plans: Members have 180 days to file appeals, with decisions typically within 30-45 business days for standard cases or 72 hours for expedited reviews.

When to Request Expedited Review

Request expedited processing if:

  • Delay would seriously jeopardize your life or health
  • You're experiencing breakthrough HAE attacks while awaiting approval
  • You're transitioning from another prophylactic therapy
  • Your physician attests that standard timelines pose medical risk

Call Aetna member services immediately to request expedited review—don't wait for written confirmation.

Step Therapy Protections (Effective 2026)

Starting January 1, 2026, New York's enhanced step therapy law provides new protections for patients requiring Takhzyro:

Override Criteria

Plans must approve step therapy overrides within 72 hours (24 hours for urgent cases) when:

  • The required drug has failed or is contraindicated
  • The treatment is not in the patient's best interest
  • A therapeutic equivalent is unavailable

Key Protections

  • Written attestation accepted: Plans must accept your doctor's written statement that a required drug has failed
  • No off-label stepping: Plans cannot require trying off-label medications first
  • Formulary change protection: If Takhzyro was previously approved, plans cannot impose new step therapy after formulary changes unless safety concerns exist

These protections apply to all New York health plans, including Aetna commercial and marketplace plans.

External Review Process

If Aetna denies your internal appeal, New York's external review process provides a final avenue for coverage.

Filing Requirements

Timeline for Decisions

Review Type Decision Timeline
Standard external appeal 30 days
Urgent external appeal 72 hours
Formulary exception (standard) 72 hours
Formulary exception (expedited) 24 hours

How to File

Preferred method: DFS Online Portal

Alternative methods:

  • Email: [email protected]
  • Fax: (800) 332-2729
  • Mail: DFS, 99 Washington Ave, Box 177, Albany, NY 12210

For expedited cases, call (888) 990-3991 immediately after submitting.

Practical Appeals Scripts

Patient Phone Script for Aetna

"I'm calling to appeal the denial of Takhzyro for my hereditary angioedema. I have confirmed HAE type I with documented attacks despite current prophylaxis. I need to request an expedited appeal because I'm having breakthrough attacks. Can you please provide the appeal form and expedite this review?"

Clinician Peer-to-Peer Script

"This patient has confirmed HAE type I/II with C4 and C1-INH functional testing. They've had [X] attacks in the past [timeframe] despite [current prophylaxis]. Takhzyro is FDA-approved for HAE prophylaxis and is medically necessary to prevent life-threatening airway attacks. The patient meets all clinical criteria in your policy."

When to Escalate Beyond Aetna

Community Health Advocates

Contact Community Health Advocates for free assistance:

  • Phone: (888) 614-5400 (Mon-Fri 9 AM-4 PM)
  • Services: Appeal guidance, external review filing, billing disputes
  • Languages: 170+ languages available

New York Department of Financial Services

File complaints about Aetna's handling of your case:

  • Website: DFS Consumer Complaints
  • Phone: (800) 400-8882
  • Issues: Delayed decisions, inappropriate denials, procedural violations

Common Denial Reasons & Solutions

Denial Reason How to Overturn Key Documents
"Not medically necessary" Provide attack documentation, C1-INH levels, prior therapy failures Attack diary, lab results, medical records
"Experimental/investigational" Cite FDA approval for HAE prophylaxis FDA label
"Step therapy not completed" Document contraindications or failures of Cinryze, Haegarda, Orladeyo Allergy records, prior auth denials, adverse event reports
"Quantity limits exceeded" Justify dosing based on attack frequency and weight Clinical notes supporting q2-week dosing
From our advocates: "We've seen Aetna approvals increase significantly when appeals include specific attack frequency data and cite the plan's own medical policy language. Don't just say 'frequent attacks'—provide exact dates and severity scores when possible."

FAQ

How long does Aetna (CVS Health) prior authorization take in New York? Standard PA decisions take 30-45 business days; expedited reviews are completed within 72 hours if your doctor attests that delay would jeopardize your health.

What if Takhzyro is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. If denied, this qualifies for expedited external appeal with 72-hour decisions in New York.

Can I request an expedited appeal for Takhzyro? Yes, if you're experiencing breakthrough HAE attacks or your physician attests that standard timelines pose medical risk. Call Aetna immediately to request expedited processing.

Does step therapy apply if I've tried other HAE medications outside New York? Yes, document all prior therapies regardless of where they were tried. Starting in 2026, New York law requires plans to accept written physician attestation of drug failure.

What happens if Aetna misses appeal deadlines in New York? Missing deadlines may result in automatic approval under federal law. Contact Community Health Advocates or file a complaint with the NY Department of Financial Services.

How much does Takhzyro cost without insurance? The wholesale acquisition cost is approximately $26,353 per 300mg vial or $13,176 per 150mg vial. Takeda's patient assistance program may provide support for eligible patients.

When navigating insurance approvals becomes overwhelming, specialized services like Counterforce Health can help by analyzing your specific denial and crafting targeted appeals that address each plan requirement with the right clinical evidence and policy citations.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations change frequently. Always consult with your healthcare provider and insurance company for the most current requirements and procedures specific to your situation.

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