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Cardiology

Opsumit

Generic: macitentan

Manufacturer: Johnson & Johnson  ·  Program: Johnson & Johnson Patient Assistance Program

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Eligibility Criteria

Insurance Requirement

Uninsured or has commercial, employer-sponsored, or government coverage that does not fully meet their needs

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
  • proof of insurance status

Indicated For

Pulmonary Arterial Hypertension (PAH)

About This Medication

# Johnson & Johnson Patient Assistance Program Patient Guide: How to Get Opsumit (macitentan) at Low or No Cost Opsumit (macitentan) is a prescription medication used to treat pulmonary arterial hypertension (PAH), a serious condition that affects blood vessels in the lungs and heart. The **Johnson & Johnson Patient Assistance Program** helps eligible patients get Opsumit at no cost for up to one year if they meet income and other requirements.[1][2] This guide explains everything you need to know in simple terms. ## About Opsumit (macitentan) **Opsumit** is an endothelin receptor antagonist (ERA) tablet taken once daily to slow disease progression in PAH by relaxing blood vessels in the lungs. It helps improve exercise capacity and delay worsening symptoms like shortness of breath or fatigue. Always take it exactly as prescribed by your doctor, and note it requires regular monitoring for liver function and other side effects. This program provides the medication free to those who qualify, but it does not cover doctor visits, tests, or other treatment costs.[1][7] ## Who Qualifies for the Program? You may qualify if you: - Live in the US or Puerto Rico. - Have a valid prescription for Opsumit from a US-licensed doctor for outpatient use. - Meet income eligibility (household income below certain limits based on family size). - Are uninsured, underinsured, or have commercial, employer-sponsored, or government insurance that doesn't fully cover your needs.[1][6][7] **Medicare Part D patients**: You may qualify if you're not eligible for Low-Income Subsidy (LIS) or spend more than 4% of your gross annual household income on prescriptions. Provide proof like pharmacy reports or EOB statements.[2][7] The program reviews applications case-by-case. It's for patients facing access or affordability challenges.[7] ## Income Eligibility Breakdown Specific income thresholds aren't publicly detailed and vary by medication, family size, and location. Generally, eligibility is up to **400% of the Federal Poverty Level (FPL)** or similar, but confirm during application as it's needs-based.[1][6] For reference, 2026 FPL guidelines (approximate): | Household Size | 100% FPL | 400% FPL (Typical Max) | |---------------|----------|------------------------| | 1 person | $15,060 | $60,240 | | 2 people | $20,440 | $81,760 | | 3 people | $25,820 | $103,280 | | 4 people | $31,200 | $124,800 | | +1 person | +$5,380 | +$21,520 | *Notes*: These are estimates; actual limits may be lower/higher. Include proof like 1040 tax return. Puerto Rico residents need extra financial docs.[2][4] Call (833) 742-0791 for your exact threshold.[2] ## Insurance Requirements - **Uninsured**: Fully eligible if other criteria met. - **Commercial/Employer**: Eligible if coverage doesn't meet needs (e.g., high copays). - **Government (Medicare/Medicaid)**: Possible if underinsured; Medicare Part D needs spend >4% income proof or LIS ineligibility (for ≤150% FPL).[2][6][7] Provide front/back of insurance cards. Program checks coverage first.[3][4] ## Step-by-Step Application Process 1. **Talk to your doctor**: They must complete/sign the prescription section of the enrollment form.[3][4] 2. **Gather documents**: - Proof of income (e.g., 1040 tax return). - Proof of residency (e.g., utility bill). - Prescription. - Insurance cards (front/back) or status proof. - For Medicare: Out-of-pocket spend proof if needed.[2][4] 3. **Choose method** (multiple options): - **Online**: Visit JJPatientAssistance.com or portal.jnjwithme.com/patient-assistance/enroll. Upload form/docs.[2][3] - **Phone**: Call (833) 742-0791 or (866) 228-3546, Mon-Fri 8AM-8PM ET.[1][2] - **Fax**: Download form from jnjwithme.com, complete with doctor, fax to 833-512-0497 with docs.[3][4][7] 4. **Complete forms**: Patient info, insurance, income, doctor prescription (page 3), consent/authorization (pages 4-7 or online).[4] 5. **Submit**: Program reviews insurance/eligibility, updates you and doctor.[3] *Tip*: Missing info delays processing. Use enrollment checklist.[4] ## Timeline and Delivery Processing time isn't specified but aim for complete submission to avoid delays. Once approved, medication ships **directly to your home** at no cost for up to 1 year.[1][6] Expect updates via phone/email. **Reauthorization required** annually—reapply before year ends.[1][2] ## Alternatives if Denied or Ineligible - **J&J withMe/Janssen CarePath**: Cost support, free trials, foundation referrals for commercially insured.[5][8] - **Medicine Assistance Tool (MAT.org)**: Search other PAPs.[5] - **Simplefill**: Helps apply/renew (877) 386-0206.[6] - Doctor can explore copay cards, generics (no biosimilars for Opsumit), or patient foundations. - State programs or 340B clinics. No biosimilar alternatives listed for Opsumit.[provided] ## Important Disclaimer This guide is for informational purposes based on available program details as of 2026. Eligibility, terms, and availability can change—always verify with Johnson & Johnson at (833) 742-0791 or JJPatientAssistance.com. Not medical/financial advice. Consult your doctor for treatment. Program may end without notice; notify of income/insurance changes. Johnson & Johnson not liable for application errors.[1][2][4]

Program information last verified: March 30, 2026

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