Help appealing denials for this HER2-targeted therapy for NSCLC with HER2 mutations.

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Get access to this targeted therapy for HER2-mutant lung cancer.

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Understanding Your Hyrnuo (sevabertinib) Denial

Hyrnuo (sevabertinib) is a HER2-targeted tyrosine kinase inhibitor approved for adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with HER2-activating mutations who have received prior systemic therapy. Insurance denials often require proof of HER2 mutation testing and prior treatment history.

Common Reasons for Denial

  • ! HER2 mutation not documented by approved test
  • ! Prior authorization required
  • ! Prior systemic therapy not documented
  • ! Must try other targeted therapies first
  • ! Specialty tier drug not covered
  • ! Accelerated approval concerns

How We Help

We help you compile your HER2 mutation testing results, prior treatment history, and oncologist recommendations to demonstrate medical necessity for Hyrnuo.

Start your Hyrnuo appeal — it takes about 3 minutes.

Some Types of Evidence We Can Use For Supporting Your Appeal

✓ Sevabertinib is a selective HER2 tyrosine kinase inhibitor designed to target HER2-activating mutations in NSCLC.

✓ HER2 mutations occur in approximately 2-4% of NSCLC patients and represent an actionable target for precision medicine.

✓ Clinical trials demonstrated meaningful response rates and durable disease control with sevabertinib in pretreated HER2-mutant NSCLC.

✓ Targeted therapy based on tumor genomic profiling represents the standard of care for advanced NSCLC with actionable mutations.

Financial Assistance Directory

Curated copay foundations, manufacturer programs, and safety-net clinics that may help with the cost while you appeal.

For your condition

CancerCare Co-Payment Assistance Foundation

Copay assistance for chemotherapy and targeted therapies for specific cancer diagnoses. Funds open/close by cancer type.

General copay foundations & directories

NeedyMeds

Searchable database of 5,000+ patient assistance, copay, and diagnosis-specific programs. Start here if you are not sure where to look.

Eligibility: No eligibility check - the directory itself is free. Individual programs have their own income and insurance criteria.

Patient Advocate Foundation Co-Pay Relief

Direct copay assistance for insured patients with chronic, life-threatening, or rare conditions. Covers many disease funds.

Eligibility: Generally requires insurance coverage and income up to 400% of the federal poverty level (varies by fund).

Phone: 1-866-512-3861

HealthWell Foundation

Independent charity providing copay, premium, and travel assistance grants across 70+ disease funds.

Eligibility: Must have insurance covering the prescribed treatment; income thresholds vary by fund. Funds open and close as donations allow.

The Assistance Fund (TAF)

Copay, insurance premium, and travel assistance for patients with chronic and rare diseases.

Eligibility: Must have insurance and meet income limits (typically up to 500% FPL, fund-dependent).

Good Days

Copay assistance and other support for chronic-disease patients.

Eligibility: Funds vary by disease and open/close based on availability. Usually requires insurance and income under ~500% FPL.

PAN Foundation (Patient Access Network)

Disease-specific copay assistance funds for ~70 conditions. Funds open and close throughout the year - check the website or sign up for fund-open alerts.

Eligibility: Insurance required; income limits typically 400-500% of FPL depending on the fund.

NORD (National Organization for Rare Disorders)

Patient assistance, copay, and travel programs for people living with rare diseases.

RxAssist Patient Assistance Program Center

Comprehensive directory of manufacturer patient assistance programs. Search by medication to find the manufacturer's free-drug program if you are uninsured or under-insured.

Safety-net clinics & 340B

HRSA Find a Health Center (FQHC locator)

Federally Qualified Health Centers (FQHCs) provide primary care on a sliding-fee scale and dispense many medications at 340B-discounted prices, regardless of insurance status. Often the cheapest path for uninsured or under-insured patients.

HRSA 340B Program (provider directory + program info)

Background on the 340B Drug Pricing Program. Use to verify whether a particular clinic or hospital is a covered entity before assuming discounted pricing applies.

State Pharmaceutical Assistance Program (SPAP) directory

State-run programs (mostly for seniors and people with disabilities) that supplement Medicare Part D and reduce prescription costs. Availability and benefits vary by state.

Medicaid eligibility & application (Healthcare.gov)

If denied insurance is unaffordable, check Medicaid / CHIP eligibility - thresholds and pathways vary by state, and many expansion states cover adults up to 138% FPL.

Program eligibility, fund availability, and contact info change frequently. Verify with each organization before assuming a program is open.

Patient Assistance & Copay Programs

These programs may help reduce your costs while you appeal:

Bayer HYRNUO $0 Co-Pay Program ↗

Commercially insured patients may pay as little as $0 per month. Free trial program available. Bayer Patient Assistance Foundation offers free medication for eligible uninsured patients. Call 1-866-228-7723.

Eligibility requirements and program terms may change. Please verify current details directly with each organization.

Patient Advocacy & Support Organizations

These organizations provide education, support, and advocacy for patients:

American Cancer Society ↗

Nationwide voluntary health organization providing cancer support, information, and advocacy.

CancerCare ↗

Free professional support services including counseling, support groups, and financial assistance.

Cancer Support Community ↗

Largest professionally led nonprofit network of cancer support worldwide.

Frequently Asked Questions

You need documentation of HER2-activating mutations detected by an FDA-approved or validated next-generation sequencing (NGS) test. Common mutations include exon 20 insertions.

Yes, Hyrnuo is approved for patients who have received prior systemic therapy. This typically means at least one prior line of treatment for metastatic disease.

Ready to Fight Your Hyrnuo (sevabertinib) Denial?

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Disclaimer: Fight Health Insurance is not affiliated with, endorsed by, or partnered with any pharmaceutical manufacturer, healthcare provider, medical device company, or patient assistance program, including Bayer HealthCare. All information provided is for educational and informational purposes only and does not constitute medical or legal advice. Please consult with your healthcare provider regarding treatment options and with your insurance company regarding coverage decisions.