Odefsey (emtricitabine/rilpivirine/tenofovir af)
Patient Assistance Program Guide — Gilead Advancing Access Patient Assistance Program
Do You Qualify?
Income
Up to $75,300 for a single person
Insurance
Uninsured, underinsured, or Medicare Part D patients meeting specific coverage gap criteria
Residency
U.S. resident or Puerto Rico
Income Limits (500% FPL)
Calculated at 500% FPL; Gilead often reviews income on a case-by-case basis and thresholds may be adjusted for cost of living.
Based on 2025 HHS Federal Poverty Level guidelines.
# Gilead Advancing Access Patient Assistance Program: A Patient Guide to Getting Odefsey at No Cost
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Who Qualifies for the Gilead Advancing Access Patient Assistance Program?
If you have been prescribed Odefsey (emtricitabine/rilpivirine/tenofovir af) and cannot afford it, you may be able to get it at no cost through the Gilead Advancing Access Patient Assistance Program. This program is designed specifically for patients who lack adequate insurance coverage or cannot cover out-of-pocket costs on their own. If you are a single-person household, you may qualify if your annual income is at or below $75,300. To be eligible, you must be uninsured, underinsured, or enrolled in Medicare Part D and meet specific coverage gap criteria. Residency in the United States is also required. Many patients who feel they earn "too much" still qualify, so it is worth applying even if you are unsure.
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About Odefsey (emtricitabine/rilpivirine/tenofovir af)
Odefsey is a prescription antiretroviral medication approved by the FDA to treat HIV-1 infection in adults and adolescents. It belongs to a class of drugs known as a combination antiretroviral therapy, pairing a non-nucleoside reverse transcriptase inhibitor (NNRTI) with two nucleoside reverse transcriptase inhibitors (NRTIs) in a single daily tablet. Because HIV treatment requires consistent, long-term use of medication, the cost of Odefsey — often several thousand dollars per month without coverage — can be a serious financial burden. Manufactured by Gilead Sciences, Odefsey is not currently available in a generic or biosimilar form, which is one reason the list price remains high for uninsured and underinsured patients.
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Income Eligibility: Full Breakdown
The Gilead Advancing Access Patient Assistance Program uses income thresholds set at approximately 500% of the Federal Poverty Level (FPL). Your eligibility is based on your total household income and the number of people living in your home.
| Household Size | Maximum Annual Income |
|---|---|
| 1 person | $75,300 |
| 2 persons | $102,200 |
| 3 persons | $129,100 |
| 4 persons | $156,000 |
Income is typically verified using your most recent federal tax return (Form 1040), a W-2, or three months of recent pay stubs. Gilead reviews applications on a case-by-case basis, and income thresholds may be adjusted to account for regional cost-of-living differences, so patients who fall slightly above these limits are still encouraged to apply.
If your income exceeds these limits, Gilead may still work with you or direct you toward other assistance options. Do not assume you are automatically disqualified. A program representative can help you understand your options when you call (800) 226-2056.
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Insurance Requirements Explained
Your insurance status plays a key role in determining how this program can help you. Here is how different situations are handled:
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Step-by-Step: How to Apply
Follow these steps to apply for the Gilead Advancing Access Patient Assistance Program:
1. Gather your documents before you start. You will need: a completed application form with your prescriber's signature, proof of income (Form 1040, W-2, or three months of pay stubs), and a valid prescription for Odefsey.
2. Choose your application method. You can apply online, by phone, or by fax.
- Online: Visit https://www.gileadadvancingaccess.com/ to start your application digitally.
- Phone: Call (800) 226-2056 to speak with a program specialist who can guide you through the process or submit on your behalf.
- Fax: Complete a paper application and fax it to (800) 216-1140.
3. Complete the application form. Make sure every required field is filled in, and that your prescriber signs where required. Missing signatures are one of the most common reasons for delays.
4. Submit your income documents along with your application. Copies are acceptable; you do not need to send originals.
5. Confirm receipt. After submitting, follow up by phone to confirm that your application was received and that no additional information is needed.
6. Wait for a determination. Processing typically takes 7 to 10 business days after a complete application is received.
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What to Expect: Timeline and Delivery
Once your complete application is submitted, you can expect a decision within 7 to 10 business days. Gilead or a program representative will contact you — and in some cases your prescriber — to confirm approval. If approved, your medication will be shipped directly to your home address, so you do not need to visit a pharmacy for pickup. Make sure someone will be available to receive the package, as some shipments may require a signature.
Enrollment in the program is not permanent. You will need to reauthorize annually to continue receiving Odefsey through the program. Gilead typically sends a reminder before your renewal date, but it is a good idea to track this yourself so your medication supply is not interrupted.
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Alternatives If You Don't Qualify
If you do not meet the eligibility requirements for the Patient Assistance Program, there are still options available to you:
1. Biosimilar alternatives: There are currently no FDA-approved biosimilars for Odefsey, so this option is not available at this time.
2. Gilead savings card (for insured patients): If you have commercial insurance, Gilead offers a co-pay assistance card that may reduce your out-of-pocket costs. You can access it at https://www.gileadadvancingaccess.com/copay-coupon-card. This option is not available for Medicare or Medicaid patients.
3. State Pharmaceutical Assistance Programs (SPAPs): Many states run their own programs to help residents afford prescription drugs. Your state health department or insurance commissioner's office can tell you what is available where you live.
4. NeedyMeds.org: This free online database lists hundreds of assistance programs by drug name, condition, and state. It is a useful starting point if you are exploring all available options. Visit www.needymeds.org at no cost.
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*This guide is for informational purposes only and does not constitute medical or legal advice. Eligibility determinations are made solely by Gilead. Program terms may change — verify current requirements at [https://www.gileadadvancingaccess.com/copay-assistance/patient-assistance-program](https://www.gileadadvancingaccess.com/copay-assistance/patient-assistance-program) before applying.*
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Documents You'll Need
If You Don't Qualify for the Assistance Program
Manufacturer Savings Card (for insured patients)
Gilead offers a savings card that may reduce your out-of-pocket cost if you have commercial insurance. Ask your prescriber or pharmacist for current savings card details.
Common Questions
After Gilead receives a complete application — including your income documents and the prescriber-signed form — processing typically takes 7 to 10 business days. Incomplete applications may take longer, so double-check all required documents before submitting.
If you are approved, Odefsey is shipped directly to your home address. You do not need to pick it up from a pharmacy or your prescriber's office. Make sure your mailing address on the application is current and accurate.
Yes. The Gilead Advancing Access Patient Assistance Program requires annual reauthorization to confirm that you still meet income and insurance eligibility requirements. Gilead will typically notify you when it is time to renew, but tracking your enrollment date yourself can help prevent any gap in your medication supply.
Possibly. The program includes provisions for some Medicare Part D patients, particularly those who face high cost-sharing or fall into the coverage gap. Call Gilead Advancing Access at (800) 226-2056 to discuss your specific Medicare plan and find out whether you qualify.
You may still be worth applying. Gilead reviews applications on a case-by-case basis and sometimes adjusts income thresholds based on cost of living and other factors. A program specialist at (800) 226-2056 can help you understand your options before you decide not to apply.
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