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Neurology

Caplyta

Generic: lumateperone

Manufacturer: Intra-Cellular Therapies  ·  Program: Intra-Cellular Therapies Patient Assistance Program

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Eligibility Criteria

Insurance Requirement

Uninsured patients only; Medicare/Medicaid patients not eligible

Residency

US resident, 18 years or older

Reviewed on case-by-case basis; patient must be uninsured

Program Information

Processing Time

2–8 weeks

Delivery Method

shipped to healthcare provider

Application Method

Fax

Reauthorization

Required — after 90 days

Typically Required Documents

ProvisionRX prepares and organizes all required documentation as part of your enrollment management. This list is provided for informational purposes.

  • completed enrollment form signed by patient and prescriber
  • proof of no insurance
  • prescription

Indicated For

schizophrenia, bipolar depression, MDD

About This Medication

# Intra-Cellular Therapies Patient Assistance Program Patient Guide: How to Get Caplyta (lumateperone) at Low or No Cost Caplyta (lumateperone) is an antipsychotic medication used to treat **schizophrenia** and **depressive episodes associated with bipolar I or bipolar II disorder** in adults. The **Intra-Cellular Therapies Patient Assistance Program (PAP)** provides this medication **at no cost** to eligible uninsured patients in the United States who meet specific income and other criteria[1][2][3]. ## About Caplyta (lumateperone) Caplyta is a once-daily oral capsule approved for adults (18 years and older) with **schizophrenia** or **bipolar depression** (depressive episodes related to bipolar I or II disorder). Unlike some older antipsychotics, Caplyta is designed to target serotonin 5-HT2A and dopamine D2 receptors with a unique mechanism that may help reduce certain side effects like weight gain or movement disorders, though individual responses vary. Always take it as prescribed by your healthcare provider, typically in the evening with or without food. Common side effects can include drowsiness, dry mouth, or nausea—discuss any concerns with your doctor[1][2][6]. This guide focuses on the **manufacturer's PAP**, which is ideal for uninsured patients struggling to afford Caplyta, which can cost over $1,000 per month without assistance. ## Who Qualifies for the Program? To qualify, you must meet **all** these criteria: - Be **18 years or older**. - Diagnosed with **schizophrenia** or **bipolar depression**. - **Uninsured** (no prescription coverage, including Medicare, Medicaid, TRICARE, or other government programs). - **U.S. resident** (some sources note excluding Puerto Rico, but confirm via application)[2][6]. - Household income **at or below 300% of the Federal Poverty Level (FPL)**, assessed case-by-case. **Medicare or Medicaid patients are not eligible**—this program is strictly for the uninsured[1][3][4][8]. ## Income Eligibility Breakdown Eligibility is based on **annual household income not exceeding 300% of the FPL**, depending on household size. Applications are reviewed **case-by-case**, so provide clear proof of income (e.g., tax returns, pay stubs, or statements if no income)[1][2][3][8]. Here's a table of **2026 FPL guidelines** (approximate; use current HHS guidelines for exact figures, as they update annually): | Household Size | 100% FPL | 300% FPL Threshold | |----------------|----------|---------------------| | 1 (Individual) | $15,060 | **$45,180** | | 2 (Couple) | $20,440 | **$61,320** | | 3 | $25,820 | **$77,460** | | 4 | $31,200 | **$93,600** | | +1 per person | +$5,380 | **+$16,140** | *Notes: FPL varies by year and location (higher in Alaska/Hawaii). If no income, explain support sources (e.g., family, benefits). Program confirms via documents[1][3][8].* ## Insurance Requirements **Uninsured only**. You must have **no health insurance** covering prescriptions. Patients with **Medicare, Medicaid, or any government-funded coverage** do not qualify. If insured, explore **CAPLYTA withMe** (commercial insurance savings) or co-pay programs separately[1][2][4][5][8]. Provide **proof of no insurance** (e.g., denial letter or self-declaration)[1]. ## Step-by-Step Application Process 1. **Get Prescribed**: Ask your doctor for Caplyta if appropriate for your schizophrenia or bipolar depression. 2. **Download Form**: Visit intracellulartherapies.com/patient-assistance or use the enrollment form (available online or via provider)[1][2]. 3. **Complete Enrollment Form**: - **Patient section**: Provide personal info, household income, number in household, diagnosis confirmation, and consent. - **Prescriber section**: Doctor completes medical details, attests to supervision, and includes prescription. 4. **Gather Required Documents**: - Completed, **signed form** (patient and prescriber). - **Proof of no insurance** (e.g., insurance denial or statement). - **Proof of income** (tax return, W-2, pay stubs, or no-income explanation). - **Valid prescription** for Caplyta[1][3][6][8]. 5. **Submit**: **Fax** to **1-888-481-4838** or mail to P.O. Box 5554, Louisville, KY 40255. You or your provider can fax[1][3][6]. ## Timeline and Delivery - **Review**: Typically **within 2 business days** after receiving complete info[3]. - **Notification**: Letter to you and your provider; provider will inform you[3]. - **Processing/Shipping**: If approved, order processed with **2-day shipping** to your **healthcare provider's office** (not directly to you)[1][3][8]. - **Initial Supply**: Up to **90-day supply**; may extend to **12 months** with reapplication[6][8]. - Pick up from provider—schedule a follow-up appointment[3]. ## Reauthorization and Refills **Reauthorization required**. Submit a **new application every 12 months** or as supply ends. Your provider must reconfirm need[3][8]. ## Alternatives if Denied - **Appeal**: Contact program for instructions; submit **provider letter** explaining circumstances. Denials can sometimes be overturned[3]. - **Other Programs**: - **CAPLYTA withMe** for commercial insurance (savings cards, not for government insurance)[5]. - Third-party aids like Simplefill or NeedyMeds for matching[7][9]. - State programs, generic alternatives (none currently), or low-cost clinics. - Discuss with provider: samples, payment plans, or bipolar/schizophrenia support orgs. If denied due to income/insurance, reapply after changes (e.g., losing insurance). ## Important Disclaimer This guide is for informational purposes based on publicly available program details as of latest updates. **Eligibility, terms, and availability can change**—always verify with Intra-Cellular Therapies at 1-888-481-4824 or their website. Not medical/financial advice; consult your healthcare provider. Program not valid where prohibited by law. Intra-Cellular Therapies (now part of Johnson & Johnson) reserves rights to modify/amend[1][2][3][4]. *Word count: ~950*

Program information last verified: March 30, 2026

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