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

Get Takhzyro (Lanadelumab-flyo) Covered by UnitedHealthcare in North Carolina: Complete Prior Authorization Guide with Forms and Appeal Scripts

Answer Box: Getting Takhzyro Approved by UnitedHealthcare in North Carolina

UnitedHealthcare requires prior authorization for Takhzyro (lanadelumab-flyo) with specific criteria: confirmed HAE diagnosis with C1-INH deficiency, baseline attack rate ≥1 per 4 weeks, and prescribing by an allergist/immunologist. Submit through the UnitedHealthcare Provider Portal with lab results, attack documentation, and medical necessity letter. If denied, file internal appeals within 180 days, then request external review through Smart NC within 120 days.

Table of Contents

  1. Start Here: Verify Your Plan and Find Forms
  2. Required Forms and Documentation
  3. Submission Portals and Electronic PA
  4. Fax Numbers and Mailing Addresses
  5. Specialty Pharmacy Setup
  6. Support Lines and Contact Numbers
  7. Appeals Process and Smart NC External Review
  8. Medical Necessity Letter Requirements
  9. Common Denial Reasons and Solutions
  10. Costs and Patient Assistance
  11. FAQ: North Carolina Specific Questions

1. Start Here: Verify Your Plan and Find Forms

Before submitting any prior authorization request, confirm your exact UnitedHealthcare plan type and locate the current Takhzyro policy.

Plan Verification Steps

  1. Check your insurance card for plan type:
    • Commercial/employer plan
    • UnitedHealthcare Community Plan (North Carolina Medicaid)
    • Medicare Advantage
    • Individual/ACA marketplace plan
  2. Access the current policy: UnitedHealthcare's Takhzyro Prior Authorization/Medical Necessity policy outlines specific requirements for 2025.
  3. Verify PA requirement: Check the UnitedHealthcare Provider Portal to confirm Takhzyro is on the prior authorization list for your plan.
Note: North Carolina doesn't have state-specific modifications to UnitedHealthcare's national Takhzyro policy, but individual employer plans may have variations.

2. Required Forms and Documentation

Core UnitedHealthcare Forms

Form Type Purpose Where to Find
Clinical Pharmacy Prior Authorization Request Standard PA submission UHC Provider Portal
Medical Necessity Letter Clinical justification Takeda template available
Formulary Exception Letter For non-formulary situations Takeda formulary exception form

Required Clinical Documentation

Diagnosis Evidence:

  • C4 level (typically low in HAE)
  • C1-INH antigenic level below normal
  • C1-INH functional level below normal
  • For HAE with normal C1-INH: genetic testing showing pathogenic variants

Attack Documentation:

  • Baseline attack rate ≥1 per 4 weeks
  • 3-6 month attack log with dates, locations, severity
  • Emergency room visits or hospitalizations
  • Use of on-demand rescue medications

Treatment History:

  • Previous prophylaxis attempts (Haegarda, Orladeyo, Cinryze)
  • Reasons for failure, intolerance, or contraindications
  • Current on-demand therapy usage

3. Submission Portals and Electronic PA

Primary Submission Method

UnitedHealthcare prioritizes electronic submission through their provider portal:

  • Portal URL: uhcprovider.com
  • Required account: One Healthcare ID
  • Navigation: Prior Authorization and Notification → Clinical Pharmacy/Drugs
  • Upload capacity: Supports lab results, chart notes, and medical necessity letters

Electronic PA Process

  1. Log into the UnitedHealthcare Provider Portal
  2. Select "Prior Authorization and Notification"
  3. Choose "Clinical Pharmacy" for Takhzyro
  4. Complete the electronic form with patient and clinical data
  5. Upload all supporting documentation
  6. Submit and note the confirmation number
Tip: OptumRx is actively improving prior authorization processes with enhanced automation for faster approvals.

4. Fax Numbers and Mailing Addresses

National OptumRx Fax Lines

When electronic submission isn't available:

  • OptumRx Non-Specialty Medications: 800-527-0531
  • General Pharmacy PA: 866-940-7328 (verify with plan-specific documentation)

UnitedHealthcare Community Plan (North Carolina Medicaid)

  • Provider Services: 800-638-3302
  • OptumRx Pharmacy Support: 866-376-6780 or 844-736-2724
Important: Fax numbers can change. Always verify the current number through the UHC Provider Portal or your plan-specific PA form before sending.

5. Specialty Pharmacy Setup

Takhzyro requires specialty pharmacy dispensing due to cold-chain storage and injection training requirements.

OptumRx Specialty Pharmacy Process

  1. Enrollment: Once PA is approved, OptumRx Specialty will contact the patient
  2. Training: Injection technique education and supplies provided
  3. Delivery: Temperature-controlled shipping to patient's home
  4. Monitoring: Adherence support and side effect tracking

Patient Coordination Steps

  • Ensure correct shipping address and phone number
  • Coordinate delivery timing for refrigerated medication
  • Complete any required enrollment forms
  • Schedule injection training if needed

6. Support Lines and Contact Numbers

For Providers

Contact Type Number Hours Purpose
Provider Services Number on member ID card Varies by plan PA status, policy questions
OptumRx Provider Line 866-376-6780 Business hours Pharmacy benefit questions
UHC Community Plan (NC) 800-638-3302 8am-6pm ET, Mon-Sat Medicaid managed care

For Patients

  • Member Services: Number on insurance card
  • OptumRx Member Line: 855-473-8889 (for mail-order pharmacy)
  • Smart NC Consumer Help: 1-855-408-1212 (for appeals assistance)

What to Ask When Calling

For PA Status:

  • "What's the status of prior authorization request #[number]?"
  • "What additional documentation is needed?"
  • "What's the expected decision timeline?"

For Denials:

  • "Can you explain the specific denial reason?"
  • "What's the internal appeal process and deadline?"
  • "Do I qualify for expedited review?"

7. Appeals Process and Smart NC External Review

UnitedHealthcare Internal Appeals

Timeline: 180 days from denial date for standard appeals

Submission Methods:

  • Online through UHC Provider/Member Portal
  • Fax to number provided in denial letter
  • Mail to address in denial letter

Smart NC External Review (North Carolina)

If UnitedHealthcare's internal appeals are unsuccessful, North Carolina residents can request independent external review through Smart NC.

Eligibility Requirements:

  • Must have completed UHC's internal appeal process
  • State-regulated plan (not self-funded employer plans)
  • Denial based on medical necessity or experimental/investigational determination

How to Request External Review:

  1. Get the form: Download the External Review Request Form from NC Department of Insurance
  2. Gather documents: UHC's final denial letter, medical records, supporting documentation
  3. Submit within 120 days of final internal denial
  4. Contact Smart NC: Call 1-855-408-1212 for assistance

Review Timelines:

  • Standard Review: 45 days
  • Expedited Review: 72 hours (requires physician certification of urgency)
Important: Smart NC's external review decisions are binding on UnitedHealthcare. If they approve coverage, UHC must provide it within 3 business days.

8. Medical Necessity Letter Requirements

Essential Components

Your prescriber's medical necessity letter should include:

Patient Information:

  • Name, DOB, member ID
  • ICD-10 code: D84.1 (Defects in complement system)

Diagnosis Documentation:

  • Confirmed hereditary angioedema Type I or II
  • Lab values: C4, C1-INH antigenic and functional levels
  • Family history if applicable

Clinical Justification:

  • Baseline attack frequency ≥1 per 4 weeks
  • Severity and impact (ER visits, hospitalizations, missed work/school)
  • Previous prophylaxis trials and outcomes
  • Why Takhzyro is medically necessary

Prescriber Credentials:

  • Specialty (allergist/immunologist preferred)
  • Statement of medical necessity
  • Signature and date

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific medical necessity letters that address each plan's unique requirements.

9. Common Denial Reasons and Solutions

Denial Reason Solution Strategy
No confirmed HAE diagnosis Submit C1-INH lab results and genetic testing if applicable
Insufficient attack frequency Provide detailed 6-month attack log showing ≥1 attack per 4 weeks
Step therapy required Document failure/intolerance of Haegarda or other first-line prophylaxis
Non-formulary status Submit formulary exception with clinical justification
Prescriber specialty Ensure prescription comes from allergist/immunologist
Combination therapy Confirm no concurrent use with other HAE prophylaxis

Appeal Script for Patients

"I'm calling about my prior authorization denial for Takhzyro. My confirmation number is [X]. My doctor says this medication is medically necessary for my hereditary angioedema. I'd like to file an internal appeal and need to know what additional documentation you require and the deadline for submission."

10. Costs and Patient Assistance

Takhzyro Pricing

  • 300mg vial: Approximately $26,353 (wholesale acquisition cost)
  • 150mg vial: Approximately $13,176

Patient Assistance Options

Takeda Patient Assistance:

North Carolina Resources:

  • Smart NC assistance with appeals (1-855-408-1212)
  • North Carolina Medicaid expansion (effective 2024) for additional coverage options

11. FAQ: North Carolina Specific Questions

Q: How long does UnitedHealthcare PA take in North Carolina? A: Standard PA decisions: 3-5 business days. Expedited (urgent) requests: typically 72 hours.

Q: What if Takhzyro is non-formulary on my plan? A: Submit a formulary exception request using Takeda's template with clinical justification.

Q: Can I request expedited review for urgent HAE attacks? A: Yes, if ongoing attacks pose immediate health risks. Your doctor must certify urgency in writing.

Q: Does North Carolina have special HAE coverage requirements? A: No state mandate exists, but Smart NC provides robust external review rights for all specialty drug denials.

Q: What if I move to North Carolina mid-treatment? A: Continue with your current UHC plan. Transfer specialty pharmacy services to North Carolina OptumRx network.

Q: How do I transfer from another HAE prophylaxis to Takhzyro? A: Document the clinical reason for switch (inadequate control, side effects, convenience) and ensure no overlap period.

When navigating complex prior authorization requirements, tools like Counterforce Health can help transform denial letters into targeted appeals by analyzing payer policies and crafting evidence-based responses that speak directly to each plan's specific criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional help with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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