JYNARQUE

Indicated For

autosomal dominant polycystic kidney disease, ADPKD

About This Medication

# Otsuka Patient Assistance Foundation Patient Guide: How to Get JYNARQUE at Low or No Cost JYNARQUE (tolvaptan) is a prescription medication used to slow the progression of autosomal dominant polycystic kidney disease (ADPKD) in adults at risk of rapidly declining kidney function. The **Otsuka Patient Assistance Foundation** offers this important treatment **at no cost** to eligible uninsured or underinsured patients who meet income and other requirements. ## About JYNARQUE and Why Access Matters **JYNARQUE** is an oral tablet taken twice daily that works by blocking vasopressin receptors in the kidneys, reducing cyst growth and kidney enlargement in ADPKD—a genetic condition causing fluid-filled kidney cysts that can lead to kidney failure. Early treatment can preserve kidney function longer, delaying the need for dialysis or transplant. However, its high list price (often over $500,000 annually) makes it inaccessible without assistance. The Otsuka Patient Assistance Foundation bridges this gap by providing **free medication** to those who qualify, ensuring patients don't skip doses due to cost. ## Who Qualifies? This program targets **U.S. residents** who are **uninsured or underinsured** (e.g., insurance denies coverage or prior authorization fails) and have **limited income**. You must have a valid prescription from a U.S. healthcare provider. Importantly: - **No U.S. citizenship required**, but proof of U.S. residency is mandatory. - **Income limits apply** based on household gross income; exact Federal Poverty Level (FPL) percentages aren't publicly specified but require documentation showing financial need. - Patients with **Medicare, Medicaid, or certain commercial insurance** may qualify if underinsured (e.g., coverage denied). - **Healthcare provider involvement** is key—they complete much of the form and submit it. ## Income Eligibility Breakdown Specific income thresholds aren't fixed publicly and vary; applications are reviewed case-by-case with **proof of household income for all contributing members**. Provide **one** document per person, such as: | Income Document Type | Examples | Notes | |----------------------|----------|-------| | Tax Forms | Federal 1040, W-2, 1099-MISC | From previous tax year | | Pay Proof | 2 most recent paystubs | Covers all household contributors | | Government Benefits | Social Security award letter, unemployment letter, disability info | Official letters only | | Other | Employer letter on letterhead | Must verify gross income | **No income?** Enter zero and explain. Incomplete income proof delays approval. Expect **financial documentation review** to confirm eligibility. ## Insurance Requirements - **Uninsured patients**: Fully eligible if other criteria met. - **Underinsured**: Submit **denial proof**, like: - Explanation of Benefits (EOB) - Insurance statement - Prior authorization denial letter - **Medicare/Medicaid**: May qualify if program denies coverage; include denial docs. - **Active commercial insurance**: Often ineligible unless coverage is rejected. ## Step-by-Step Application Process **Work with your doctor**—they handle most steps via the **OPAF Care Connect portal** (www.otsukapatientassistance.com) for fastest processing. 1. **Discuss with your healthcare provider (HCP)**: Confirm JYNARQUE prescription. They access forms at **Patient Forms** section or **Apply for Your Patients** portal. 2. **Patient completes sections**: - Sign **patient authorization** (page 2). - Fill **personal info** (name, address, DOB, contacts; include caregiver if applicable). - Detail **insurance** (yes/no; add denial docs if underinsured). - List **household income** and attach proofs. - Provide **proof of residency** (e.g., utility bill, driver's license, rental agreement, or HCP attestation). 3. **Gather required documents**: - Prescription (required in NY, NJ, IA; recommended everywhere). - Proof of income (all household). - Proof of residency. - Insurance denial (if applicable). 4. **Submit** (HCP or patient): - **Fastest: Online portal** (48 hours eligibility check). - Fax: 1-844-727-6274. - Mail: Otsuka Patient Assistance Foundation, PO Box varies (e.g., Chesterfield, MO 63006—confirm current on site). - Phone help: (888) 591-9812 or 1-855-727-6274 (Mon-Fri, 8AM-8PM ET). 5. **Watch for notifications**: HCP and patient contacted on status. **Tip**: Complete apps process quicker; missing docs cause delays. ## Timeline and Delivery - **Online submission**: Eligibility in **up to 48 hours**; full process ~2-3 business days. - **Paper (fax/mail)**: Up to **5 business days** after receipt. - **Approved?** Medication **shipped free to your home** (no cost). You'll get mailed notice. - **Reauthorization required**: Ongoing assistance isn't automatic—**reauth** needed periodically (HCP resubmits updated info). ## Alternatives if Denied or Ineligible - **Appeal**: Contact OPAF if more info helps (they'll reach out via HCP). - **Manufacturer savings cards**: Check Otsuka copay programs for insured patients (separate from OPAF). - **Other assistance**: - PAN Foundation or HealthWell for kidney disease grants. - State ADPKD programs or NeedyMeds.org. - Generic tolvaptan (if available; none currently). - Clinical trials via ClinicalTrials.gov. - **No biosimilars** for JYNARQUE. ## Important Disclaimer This guide is for informational purposes based on available program details as of latest data. **Eligibility isn't guaranteed**—OPAF reviews each case. Rules can change; visit www.otsukapatientassistance.com or call (888) 591-9812 for updates. Not medical advice—consult your doctor. OPAF is independent; Otsuka doesn't control decisions. Report side effects: Otsuka at 1-800-438-9927 or FDA at 1-800-FDA-1088. (Word count: 942)

Program information last verified: March 30, 2026