HETLIOZ

Indicated For

Non-24-Hour Sleep-Wake Disorder, Smith-Magenis Syndrome

About This Medication

# HETLIOZ Solutions Patient Assistance Program Patient Guide: How to Get HETLIOZ (tasimelteon) at Low or No Cost HETLIOZ (tasimelteon) is a prescription medication approved by the FDA to treat **Non-24-Hour Sleep-Wake Disorder** (Non-24) in adults and nighttime sleep disturbances in children and adults with **Smith-Magenis Syndrome (SMS)**. The **HETLIOZ Solutions Patient Assistance Program**, offered by Vanda Pharmaceuticals, Inc., helps eligible patients—whether commercially insured, underinsured, or uninsured—access this medication at low or no cost through financial support, insurance navigation, and home delivery coordination.[1][3] ## About HETLIOZ and Non-24 **Non-24** is a rare circadian rhythm disorder that affects many totally blind individuals. Without light cues reaching the brain, their internal body clock fails to sync with the 24-hour day, causing sleep-wake cycles to shift gradually—often leading to daytime sleepiness and nighttime insomnia. HETLIOZ works by mimicking melatonin to help reset this internal clock, taken daily about 1 hour before bedtime.[3][6] For SMS, a genetic condition causing developmental delays and sleep issues, HETLIOZ helps improve nighttime sleep.[6] HETLIOZ comes as capsules or oral suspension (HETLIOZ LQ®). It's a specialty medication dispensed through pharmacies partnered with the program, ensuring proper handling and delivery to your door.[1][2] ## Who Qualifies for the Program? The HETLIOZ Solutions Patient Assistance Program supports patients with a valid prescription for HETLIOZ who meet eligibility based on insurance status and financial need. Key qualifiers include: - **Commercially insured patients**: Eligible for copay assistance to reduce out-of-pocket costs. - **Underinsured patients**: Help finding alternative coverage or additional financial aid. - **Uninsured patients**: Access to free or low-cost medication through the Vanda Patient Assistance Program (PAP).[1][3][4][8] **Enrollment in HETLIOZ Solutions™ is required** for financial assistance, though not for receiving the prescription itself. A Patient Care Coordinator will assess your situation one-on-one.[2] ## Income Eligibility Breakdown Specific federal poverty level (FPL) thresholds are not publicly detailed in program materials, as eligibility emphasizes insurance status over strict income limits. However, the Vanda PAP typically targets uninsured or underinsured patients unable to afford therapy, requiring financial documentation for approval.[4] Here's a general overview based on similar programs (consult your coordinator for personalized assessment): | Patient Status | Likely Eligibility | Financial Review | |---------------|-------------------|------------------| | **Commercially Insured** | High – Copay cards or mitigation | Minimal; benefits investigation[8] | | **Underinsured** | High – Bridge coverage or aid | Income docs may apply[3] | | **Uninsured** | Eligible via PAP | Proof of income, assets required (e.g., tax returns)[4] | | **Medicare/Medicaid** | Limited; program focuses on commercial/uninsured | Coordinator checks alternatives[3] | Contact the program for exact criteria, as they adapt to your circumstances.[1] ## Insurance Requirements The program welcomes **commercially insured, underinsured, or uninsured patients**. Your Patient Care Coordinator starts with a **benefits investigation** to verify coverage, copays, or deductibles. If underinsured, they seek supplemental options. Medicare patients may have restrictions, as assistance prioritizes non-government insurance; explore foundation support or PAP for uninsured gaps.[1][3][8] No prior authorization is mentioned, but the coordinator handles prior approvals if needed.[2] ## Step-by-Step Application Process Applying is straightforward and phone-based—no online portal required. Here's how: 1. **Get a Prescription**: Ask your doctor for HETLIOZ and discuss HETLIOZ Solutions. 2. **Call 1-844-HETLIOZ (1-844-438-5469)**: You or your doctor calls (available 9 AM–8 PM ET). Expect an **introduction call within 24 hours**.[1][2][8] 3. **Meet Your Coordinator**: They'll explain enrollment, review insurance, and check financial assistance eligibility. 4. **Complete Forms**: Your doctor fills the **Prescription & Service Request Form** with patient demographics, insurance, and prescriber info. Fax to 1-844-364-2424 if needed.[2][8] 5. **Submit Documents**: Provide proof of income/residency for PAP (e.g., tax returns). Mail/fax to Vanda PAP: PO Box 5823, Louisville, KY 40255 or 1-844-826-3203.[4] 6. **Approval and Next Steps**: Coordinator forwards to a **specialty pharmacy** for final coordination.[3] **Reauthorization is required** periodically to continue benefits—your coordinator will guide renewals.[program details] ## Timeline and Delivery - **Initial Contact**: Response within 24 hours of calling.[2] - **Processing**: Varies; benefits check and approval often quick for copay aid, longer (weeks) for PAP with financial review.[4] - **Delivery**: Via **specialty pharmacy with home delivery**. Refill reminders and adherence support included.[1][3][8] Track progress via your dedicated coordinator. ## Alternatives if Denied or Ineligible - **Copay Program**: For commercial insurance if PAP denied.[8] - **Foundation Support**: Coordinator can connect to non-Vanda aid.[2] - **Other Options**: Patient Access Network (PAN) Foundation or state programs for sleep disorders. - **Appeal**: Resubmit with additional docs; coordinator assists. - **No Biosimilars**: HETLIOZ has no alternatives listed.[program details] ## Important Disclaimer This guide is for informational purposes based on publicly available program details as of March 2026. Eligibility, terms, and availability can change—**always verify with HETLIOZ Solutions at 1-844-438-5469**. Not a substitute for medical advice. Vanda may discontinue programs anytime. Consult your doctor before starting HETLIOZ. Financial assistance not guaranteed; government-insured patients may be ineligible.[1][2][4]

Program information last verified: March 30, 2026