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TAKHZYRO

Generic: lanadelumab-flyo

Manufacturer: Takeda  ·  Program:

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Eligibility Criteria

Insurance Requirement

See program details

Residency

US residency required

Income Threshold

Up to 500% FPL

Individual Income Limit

$72,900/year

Must lack adequate insurance coverage

Program Information

Processing Time

2–3 weeks

Delivery Method

shipped to patient or physician office

Application Method

Multiple

Indicated For

Hereditary Angioedema (HAE)

About This Medication

# Takeda Patient Support Patient Guide: How to Get TAKHZYRO (lanadelumab-flyo) at Low or No Cost TAKHZYRO (lanadelumab-flyo) is a prescription medicine used to prevent hereditary angioedema (HAE) attacks in adults and children 12 years and older. Takeda's Patient Support program offers co-pay assistance for eligible commercially insured patients and free medication through Help at Hand for uninsured or underinsured U.S. residents.[1][2][5][8][10] ## About TAKHZYRO and Hereditary Angioedema (HAE) **Hereditary angioedema (HAE)** is a rare genetic condition causing sudden, painful swelling attacks in areas like the face, hands, feet, genitals, or throat, which can be life-threatening if they block airways. TAKHZYRO is a monoclonal antibody that inhibits plasma kallikrein, reducing HAE attack frequency by preventing bradykinin production, the key driver of swelling.[10] Administered as a subcutaneous injection every 2 weeks (300 mg/2 mL dose), it can be self-injected or given by a caregiver after training. Clinical studies show it significantly lowers attack rates, with many patients experiencing near-complete prevention. Always consult your doctor to confirm if TAKHZYRO is right for your FDA-approved indication.[2][10] Takeda Patient Support provides comprehensive help beyond the drug: insurance navigation, specialty pharmacy coordination, product training (including at-home nursing), and education resources like the 'New to TAKHZYRO' on-demand program for your first 30 days.[1][6][7] ## Who Qualifies for Takeda Patient Support? Takeda offers **two main assistance tracks**: 1. **Co-Pay Assistance Program**: Covers up to **100% of out-of-pocket co-pays**, potentially reducing costs to $5 per dose for eligible patients. Must have **commercial insurance** (including Marketplace plans) – **not Medicare, Medicaid, VA, TRICARE, or other government programs**. Cannot be used if insurance covers 100% or during Medicare Part D coverage gap. Excludes co-pay maximizer plans.[2][8] 2. **Help at Hand (Patient Assistance Program)**: Provides **TAKHZYRO free of charge** to uninsured patients, those awaiting insurance, or those without adequate coverage. Needs-based for U.S. residents (including Puerto Rico); annual reassessment required.[5][8] Support specialists assist everyone, including benefits investigation and appeals help.[1][4] ## Income Eligibility Breakdown Co-Pay Assistance has **no specific income limits** listed but requires commercial insurance and FDA-approved use.[2] Help at Hand is **needs-based** without published FPL thresholds; eligibility determined case-by-case via annual review.[5][8] | Household Size | Co-Pay Program | Help at Hand | |---------------|----------------|--------------| | Individual | Commercial insurance only; no income cap specified | Needs-based (contact for assessment) | | Couple | Commercial insurance only; no income cap specified | Needs-based (contact for assessment) | | Family of 3 | Commercial insurance only; no income cap specified | Needs-based (contact for assessment) | | Family of 4 | Commercial insurance only; no income cap specified | Needs-based (contact for assessment) | | % of FPL | Not applicable | Not specified; case-by-case | *Notes: Call 1-866-888-0660 (Mon-Fri, 8:30 AM-8:00 PM ET) for personalized eligibility check. Programs subject to change.[1][5]* ## Insurance Requirements - **Commercial/Private Insurance**: Eligible for co-pay help (up to 100% coverage).[2] - **Government Insurance (Medicare, Medicaid, etc.)**: Ineligible for co-pay program.[2] - **Uninsured/Underinsured**: Qualify for free drug via Help at Hand while seeking coverage or if none available.[5][8] Takeda helps find insurance plans and refers to nonprofits for premium assistance.[5] If prior authorization (PA) denied, use appeal templates (Formulary Exception, Letter of Intent to Treat, Statement of Medical Necessity).[4] ## Step-by-Step Application Process 1. **Get Prescribed**: Confirm with your doctor that TAKHZYRO is for FDA-approved HAE prophylaxis.[2] 2. **Contact Takeda**: Call **1-866-888-0660** (Mon-Fri, 8:30 AM-8 PM ET) or visit takhzyro.com/support. Specialists handle enrollment, benefits check, and pharmacy coordination.[1][2][5] 3. **Enroll Online or Fax**: - Use the **online portal** for fastest enrollment.[4] - Download/fax forms to **1-855-663-7284** (physician referral starts process).[4][5] 4. **Submit Documents**: Proof of residency, prescription, income (for needs-based), insurance details (if applicable). Exact list confirmed during call.[5] 5. **Specialty Pharmacy**: Takeda coordinates delivery from your designated pharmacy or site-of-care.[1] 6. **Training**: Free at-home administration training and education.[1][7] ## Timeline and Delivery Processing time varies (not specified; typically weeks pending insurance/benefits investigation).[1] Free medication provided while awaiting coverage.[5] Medication ships via specialty pharmacy; track with support team. Refills coordinated automatically; annual reassessment for Help at Hand.[5] ## Alternatives if Denied or Ineligible - **Appeal Denial**: Use Takeda templates and support for PA appeals.[4] - **Other Programs**: Accessia Health for HAE (private insurance).[5] - **Community Resources**: Takeda connects to education and support groups.[2][7] - **Biosimilars**: None currently available.[10] - **Discuss with Doctor**: Alternative HAE prophylactics like C1 inhibitors. ## Disclaimer This guide summarizes publicly available info as of latest data; programs change. Not medical/financial advice. Eligibility not guaranteed. Consult healthcare provider and call Takeda (1-866-888-0660) for current details. Takeda reserves rights to amend/terminate.[1][2][4][5]

Program information last verified: March 30, 2026

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