XOSPATA

Indicated For

relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutation

About This Medication

# Astellas Patient Assistance Program Patient Guide: How to Get XOSPATA at Low or No Cost XOSPATA (gilteritinib) is a targeted oral therapy approved by the FDA for adults with relapsed or refractory acute myeloid leukemia (AML) with **FLT3** mutations, offering hope for patients facing this challenging blood cancer. The **Astellas Patient Assistance Program (PAP)** provides **XOSPATA at no cost** to eligible uninsured or underinsured patients who meet financial need criteria, helping remove cost barriers to essential treatment.[1][2] ## About XOSPATA and Why Access Matters **XOSPATA** is a once-daily tablet taken by mouth, specifically designed for patients whose AML has specific genetic changes called **FLT3 mutations**. These mutations occur in about 30% of AML cases and can make the disease more aggressive. Unlike traditional chemotherapy, XOSPATA targets the FLT3 protein directly, potentially slowing cancer growth and improving survival chances for those whose disease has returned or didn't respond to prior treatments.[1] AML is a fast-progressing cancer of the blood and bone marrow, and timely access to therapy like XOSPATA can be life-changing. However, without insurance coverage, the out-of-pocket costs can exceed $20,000 per month, making it unaffordable for many. That's where the Astellas PAP steps in—**providing free medication shipped directly to your home** for those who qualify, ensuring you can focus on your health rather than finances.[1][2] ## Who Qualifies for the Program? To qualify, you must: - Have a valid prescription for **XOSPATA** for an FDA-approved use (relapsed/refractory FLT3-mutated AML). - Live in the **United States** (proof of residency required). - Be **uninsured** or have insurance that **does not cover XOSPATA** (e.g., excluded by your plan).[1][2] - Meet the program's **financial eligibility requirements**, which assess household income against federal poverty levels (FPL). Specific thresholds (e.g., for individuals, couples, or families) are not publicly detailed but are evaluated case-by-case—typically for those at or below **400-500% of FPL** based on similar Astellas programs. Contact the program for your personalized assessment.[1] **Important:** Medicare Part D, Medicaid, or other public insurance may disqualify you, as the program targets those without viable coverage options.[2][3] ## Income Eligibility Breakdown The Astellas PAP evaluates income holistically, considering household size and total income. While exact cutoffs aren't listed publicly, here's a general guide based on standard patient assistance thresholds (always verify with the program): | Household Size | Estimated Max Annual Income (300% FPL)* | Estimated Max Annual Income (400% FPL)* | Notes | |---------------|---------------------------------------|---------------------------------------|-------| | **1 (Individual)** | ~$45,180 | ~$60,240 | Proof of all income sources required. | | **2 (Couple)** | ~$61,320 | ~$81,760 | Includes spouse/partner income. | | **3** | ~$77,460 | ~$103,280 | Add ~$16,140 per additional person at 300% FPL. | | **4** | ~$93,600 | ~$124,800 | Larger families may qualify higher. | *2026 FPL estimates; actual program uses current guidelines. Income includes wages, Social Security, pensions, etc. Assets may also be reviewed. **Call (844) 632-9272** for exact eligibility.[1][6] ## Insurance Requirements - **Uninsured patients** are prime candidates. - **Insured patients** qualify only if their plan **explicitly excludes XOSPATA** or prior authorization (PA) is denied. The program assists with PA processes but free drug is for those without coverage.[1][2] - **Medicare/Medicaid:** Generally ineligible, as these are public programs. If you have Medicare Part D or Advantage, explore copay assistance separately via XOSPATA Support Solutions.[1][2] - Front/back copies of **all insurance cards** must be submitted for verification.[2] ## Step-by-Step Application Process Your **healthcare provider (HCP)** starts the process—**patients cannot apply alone**. Here's how it works: 1. **Discuss with Your Doctor:** Ask about XOSPATA Support Solutions and request assessment for the Astellas PAP. Provide your financial details.[1] 2. **Complete Enrollment Form:** Your HCP fills out the **XOSPATA Support Solutions Patient Enrollment Form** (available at astellaspharmasupportsolutions.com). Key sections include patient info, insurance details, prescription, and PAP assessment.[2] 3. **Gather Documents:** - **Prescription** for FDA-approved indication. - **Proof of residency** (e.g., utility bill, driver's license). - **Proof of income** (e.g., tax returns, pay stubs, SSI statements for all household members). - **HCP enrollment form** with signatures from you, your doctor, and office contact. - Insurance card copies (front/back).[1][2][6] 4. **Submit:** HCP faxes to **1-844-730-8816**, uploads via Prescriber Portal, or calls **(844) 632-9272** (Mon-Fri, 8:30 AM–8:00 PM ET). Phone enrollment initiates quickly.[1][2] 5. **Eligibility Review:** Program verifies info; you and your HCP are notified of approval/denial.[1] **Pro Tip:** Sign the Patient Authorization Statement certifying your info is accurate and agreeing to report changes (e.g., new insurance).[2] ## Timeline and Delivery - **Processing:** Typically 1-2 weeks after complete submission, though phone starts enrollment same-day.[1] - **Approval Notification:** Via mail/email to you and HCP. - **Delivery:** **Free XOSPATA shipped directly to your home** via specialty pharmacy network. No pharmacy pickup needed.[1][2] - Refills/reauthorization may require updates; details provided upon approval. ## Alternatives if Denied - **Appeal:** Submit additional docs or updated income proof.[1] - **Copay Savings Card:** For commercially insured; HCP enrolls via portal (reduces copays to $0 for eligible).[1] - **Other PAPs:** Check RxHope.com or NeedyMeds.org for independent programs.[6] - **Manufacturer Copay Assistance:** XOSPATA Support Solutions offers benefits investigation and PA help.[1] - **State Programs:** Local AML foundations or patient advocacy groups like Leukemia & Lymphoma Society. - **Clinical Trials:** Ask your doctor about FLT3-targeted trials. No biosimilar alternatives exist for XOSPATA.[provided] ## Disclaimer This guide is for informational purposes only and based on publicly available data as of 2026. **Eligibility, terms, and availability can change—always contact Astellas directly at (844) 632-9272 or your HCP for current details.** Participation doesn't guarantee approval; falsifying info may lead to denial. Consult your doctor for medical advice. Astellas Pharma US, Inc. reserves rights to modify/amend the program.[1][2]

Program information last verified: March 25, 2026