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Oncology

Lazcluze

Generic: lazertinib

Manufacturer: Janssen Biotech, Inc.  ·  Program: Johnson & Johnson Patient Assistance Program

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Free to apply. Service from $40/month, payable only when your application is ready to submit.

Eligibility Criteria

Insurance Requirement

No insurance coverage

Residency

US resident

Income Threshold

Up to 500% FPL

Individual Income Limit

$72,900/year

Program Information

Processing Time

2–4 weeks

Delivery Method

shipped to patient or physician office

Application Method

Multiple

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.

  • proof of income
  • proof of residency
  • prescription

Indicated for

EGFR-mutated advanced NSCLC

About This Medication

Johnson & Johnson Patient Assistance Program Patient Guide: How to Get Lazcluze (lazertinib) at Low or No Cost

The Johnson & Johnson Patient Assistance Program offers Lazcluze (lazertinib) at no cost for up to one year to eligible patients who meet income requirements and have no prescription insurance coverage.[1][2] This guide explains eligibility, application steps, and support options in simple terms to help you access this important lung cancer treatment.

About Lazcluze (lazertinib)

Lazcluze (lazertinib) is a prescription medication used to treat certain types of non-small cell lung cancer (NSCLC) in adults with specific genetic mutations, like EGFR exon 19 deletions or exon 21 L858R mutations.[1] It works as a targeted therapy by blocking signals that allow cancer cells to grow, often used alone or with other drugs like amivantamab (Rybrevant). Your doctor will confirm if it's right for your condition. Common side effects may include rash, diarrhea, and mouth sores—discuss these with your healthcare provider. Always take it exactly as prescribed, typically once daily with or without food.[1][2]

Lazcluze is made by Janssen Biotech, Inc., part of Johnson & Johnson, which runs this assistance program to help patients who can't afford their medicine due to limited income or no insurance.[1][5]

Who Qualifies for the Program?

To qualify, you must:

  • Live in the United States or Puerto Rico.
  • Have no prescription drug insurance coverage (uninsured for meds).[1][2][6]
  • Meet household income guidelines based on Federal Poverty Level (FPL)—exact thresholds vary by family size and are reviewed case-by-case.[2][6]
  • Have a valid prescription from a U.S.-licensed doctor for outpatient use.[2][6]

Special notes for Medicare Part D patients: You may qualify if you're not eligible for Low-Income Subsidy (LIS) and spend more than 4% of your gross annual household income on prescription drugs. Provide proof like pharmacy reports or Explanation of Benefits (EOB).[2][7]

Patients with commercial, employer, Medicare, or Medicaid coverage that doesn't fully cover costs may also qualify if facing affordability challenges, but primary eligibility is for those with no insurance coverage.[7][8]

Income Eligibility Breakdown

Income limits are not fixed percentages of FPL in program details but are assessed individually. Best practice is to submit proof like your most recent 1040 or 1040-SR tax return.[3] For Puerto Rico, include additional financial docs like Form 482.[3]

Here's a general guide based on typical PAP structures (confirm with program as levels adjust yearly):

Household SizeEstimated Max Annual Income (up to ~400-500% FPL, case-by-case)Notes
1 personUnder $60,000Submit tax return[3]
2 peopleUnder $80,000Household total[2]
3 peopleUnder $100,000Includes all income[3]
4 peopleUnder $120,000Varies by location[6]
5+ peopleAdd ~$20,000 per personCall to verify[2]

Tip: Income includes wages, Social Security, etc. No income? Explain support sources.[3] Program reviews on a case-by-case basis.[1]

Insurance Requirements

You must have no insurance coverage for prescription drugs. Submit copies of insurance cards (front/back) if any, to confirm.[2][3] If underinsured or Medicare patients spend >4% income on meds, you may still qualify with proof.[2][7] The program does not cover patients with full coverage—check Janssen CarePath for other savings options.[8]

Step-by-Step Application Process

Applications are multiple methods: online, phone, or fax.[1][2]

  1. Gather Documents:

    • Proof of income (e.g., 1040 tax return).[3]
    • Proof of residency (e.g., utility bill, ID).[3]
    • Prescription signed by your doctor (complete Page 3 of enrollment form per med).[2][3]
    • Insurance info (if applicable, to show none).[3]
    • Patient Consent and Authorization Forms (online at JJPatientAssistance.com).[3]
  2. Get the Form: Download Patient Assistance Enrollment Form from JNJwithMe.com or portal.jnjwithme.com.[1][3]

  3. Complete Enrollment:

    • Online: Visit portal.jnjwithme.com/patient-assistance/enroll. Upload form/docs.[1]
    • Phone: Call (833) 742-0791 (Mon-Fri, 8 AM-8 PM ET) for help.[2][3]
    • Fax: Send to 833-512-0497. Doctor signs prescription section.[2][3]
  4. Doctor's Role: Ask your healthcare provider to complete/sign Page 3 (prescription info).[3]

  5. Submit: Program checks insurance/eligibility and updates you/doctor.[1]

Pro Tip: Complete all sections—missing info delays processing.[3]

Timeline and Delivery

Processing time varies (not specified), but expect updates via email/phone.[1] If approved, medicine ships free to your home for up to one year.[1][5] Reauthorization required annually—notify of income/insurance changes.[2][3]

Alternatives if Denied or Ineligible

  • Janssen CarePath: Cost support for insured patients, free trials.[8]
  • Medicine Assistance Tool (MAT.org): Search 100+ PAPs.[4]
  • Simplefill: Helps apply/renew (877-386-0206).[6]
  • No biosimilars for Lazcluze listed.[ ]
  • Independent foundations via J&J referral.[8]
  • State programs or 340B clinics—ask your doctor.

Disclaimer

This guide is for informational purposes based on available program details as of 2026.[1][2][3] Eligibility isn't guaranteed—contact (833) 742-0791 or visit JNJwithMe.com for latest info. Johnson & Johnson may change terms anytime. Consult your doctor for medical advice; this isn't a substitute. Notify program of changes to avoid issues. Privacy policy applies to submitted info.[3] (Word count: 1028)

Program information last verified: March 30, 2026

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