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Oncology

NERLYNX

Generic: neratinib

Manufacturer: Puma Biotechnology  ·  Program: Patient Assistance Program

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Eligibility Criteria

Insurance Requirement

Uninsured or underinsured with no coverage for NERLYNX; not eligible for public health insurance programs

Residency

US residents and Puerto Rico

Meets certain financial qualifications; needs-based

Program Information

Processing Time

4–8 weeks

Delivery Method

shipped to patient

Application Method

Fax

Reauthorization

Required — annual

Typically Required Documents

ProvisionRX prepares and organizes all required documentation as part of your enrollment management. This list is provided for informational purposes.

  • Completed enrollment form
  • Proof of income
  • Proof of residency
  • Proof of insurance status

Indicated For

HER2+ breast cancer

About This Medication

# Puma Biotechnology Patient Assistance Program Patient Guide: How to Get NERLYNX (neratinib) at Low or No Cost This guide explains the **Puma Biotechnology Patient Assistance Program** (PAP), which provides **NERLYNX (neratinib)** tablets free of charge to eligible uninsured or underinsured patients facing financial hardship. NERLYNX is an oral medication used to reduce the risk of breast cancer returning in adults with early-stage HER2-positive (HER2+) breast cancer after they have completed other treatments like surgery, chemotherapy, and targeted therapy[1][2][6]. ## About NERLYNX (neratinib) **NERLYNX** is a prescription medicine approved to lower the chance that HER2+ breast cancer comes back (recurs) after prior treatments. It works by targeting proteins that help cancer cells grow, specifically in HER2+ cancers. Your doctor typically starts you on a lower dose for the first two weeks to help manage side effects like diarrhea, then increases to the full dose. Common side effects include diarrhea (often severe), nausea, fatigue, vomiting, and stomach pain—Puma offers separate vouchers for free antidiarrheal medications to help with this[1][3][7]. Always take NERLYNX exactly as prescribed, usually 240 mg (six tablets) once daily for one year. Your healthcare provider will monitor your liver function with blood tests before starting, monthly for the first three months, and as needed afterward. Do not stop or adjust your dose without medical advice. NERLYNX is dispensed through specialty pharmacies that provide additional support like delivery coordination and nurse counseling[3][4][7]. ## Who Qualifies for the Patient Assistance Program? The program is designed for patients who cannot afford NERLYNX due to lack of insurance coverage or financial need. Key eligibility criteria include: - **Residency**: Must live in the US or Puerto Rico[2]. - **Financial Need**: Meets certain income-based qualifications (specific thresholds like Federal Poverty Level percentage not publicly detailed; program is needs-based)[1][2]. - **Insurance Status**: Uninsured, underinsured with no coverage for NERLYNX, or unable to afford out-of-pocket costs. Not eligible if enrolled in Medicare, Medicaid, or other public health insurance programs[2]. **Puma Patient Lynx** (call 1-855-816-5421) can help verify eligibility and explore options. This program complements others like NERLYNX Quick Start (free 3-week supply for access delays) and Co-pay Support (for commercially insured patients)[1][3][5]. ## Income Eligibility Breakdown Exact income limits (e.g., % of Federal Poverty Level) are not specified publicly and vary by household size—eligibility is determined case-by-case based on financial documentation. Contact Puma at (855) 816-5421 for a personalized assessment. Here's a general overview: | Household Size | Typical Threshold Example (if FPL-based, illustrative)* | Notes | |---------------|-------------------------------------------------------|-------| | Individual | Up to ~400-500% FPL | Needs-based review required | | Couple | Up to ~400-500% FPL | Proof of all income sources | | Family of 3 | Up to ~400-500% FPL | Includes dependents | | Family of 4+ | Up to ~400-500% FPL, adjusted per person | Call for exacts | *Illustrative based on common PAP structures; Puma confirms on application. FPL = Federal Poverty Level (updates annually)[2]. ## Insurance Requirements - **Uninsured**: Fully eligible if financially qualified. - **Underinsured**: Eligible if insurance does not cover NERLYNX or copays are unaffordable. - **Exclusions**: Ineligible for government programs like Medicare, Medicaid, VA, Tricare, or state programs. Commercial insurance patients may qualify for Co-pay Support instead (as low as $10 per prescription)[2][3][5]. Puma Patient Lynx verifies benefits and assists with prior authorizations or appeals[4][5]. ## Step-by-Step Application Process 1. **Discuss with Your Doctor**: Confirm NERLYNX is right for you. Your healthcare provider (HCP) must complete part of the enrollment form[2][5]. 2. **Call Puma Patient Lynx**: Dial **(855) 816-5421** (Mon-Fri, 9 AM-8 PM ET) for guidance, forms, and eligibility screening[1][2][3]. 3. **Gather Documents**: - Completed enrollment form (signed by patient and HCP). - Proof of income (e.g., tax returns, pay stubs, W-2s). - Proof of residency (e.g., utility bill, lease). - Proof of insurance status (e.g., denial letter or insurance card showing no NERLYNX coverage)[2]. 4. **Submit by Fax**: Fax everything to **844-276-5153**. HCP and patient sign off required[2][5]. 5. **Follow Up**: Puma reviews and contacts you. Bilingual nurses available[3]. ## Timeline and Delivery Processing time not specified—expect review within days to weeks; call for status. Once approved, NERLYNX ships **directly to your home** via specialty pharmacy. They coordinate timely delivery, confirm prescriptions by phone, and offer side-effect support. Reauthorization is required periodically to continue benefits[2][3]. Puma may provide a 21-day Quick Start supply during delays[5]. ## Alternatives if Denied or Ineligible - **NERLYNX Quick Start**: Free 3-week supply (one refill possible) for coverage delays[1][3][5]. - **Co-pay Support**: For commercial insurance, pay as little as $10[3][4]. - **Antidiarrheal Vouchers**: Free 3-month supply[1][3]. - **Nonprofit Foundations**: Puma refers to external resources[3]. - **Specialty Pharmacy Help**: Benefits investigation and appeals[3][4]. - **Mentor Program**: Connect with NERLYNX experienced patients[3][6]. If denied PAP, ask Puma for reasons and reapply with more docs or explore insurance appeals. ## Important Disclaimer This guide is for informational purposes based on publicly available program details as of 2026. Puma Biotechnology reserves the right to change, amend, or end the program anytime without notice. Eligibility not guaranteed. Always consult your healthcare provider for medical advice—do not rely solely on this guide. Program limitations apply; full terms at 1-855-816-5421. Puma is not responsible for application errors. For latest info, call Puma Patient Lynx[1][3]. (Word count: 1028)

Program information last verified: March 25, 2026

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