Kuvan

Indicated For

Phenylketonuria (PKU)

About This Medication

# KUVAN Patient Assistance Program (K-PAP) Patient Guide: How to Get KUVAN at Low or No Cost ## About KUVAN (Sapropterin Dihydrochloride) KUVAN is a prescription medication used to treat phenylketonuria (PKU), a rare genetic disorder that affects how your body processes the amino acid phenylalanine. KUVAN helps reduce phenylalanine levels in patients whose bodies respond to the medication, allowing you to manage your PKU more effectively while potentially enjoying a less restrictive diet. The medication is available as tablets or powder for oral solution. ## What is the KUVAN Patient Assistance Program (K-PAP)? The KUVAN Patient Assistance Program, administered by BioMarin Pharmaceutical Inc., is designed to help eligible patients access KUVAN at no charge when they lack adequate insurance coverage. BioMarin recognizes that PKU treatment can be costly, and this program ensures that financial barriers don't prevent you from receiving the medication you need. ## Who Qualifies for K-PAP? You may be eligible for the KUVAN Patient Assistance Program if you meet the following criteria: - **You are a legal United States resident** - **You have a valid prescription for KUVAN from a licensed healthcare provider** - **You are uninsured or have inadequate insurance coverage** for KUVAN - **You are being treated as an outpatient** - **Your household income meets program requirements** (specific thresholds are determined on a case-by-case basis) If you have insurance that does not cover KUVAN or provides insufficient coverage, BioMarin's support team will first work with you to explore alternative insurance options before determining K-PAP eligibility. ## Income Eligibility While specific income thresholds are not publicly listed, the program evaluates eligibility on a case-by-case basis. During your application, you'll need to provide proof of your household income. The program is designed for patients without insurance coverage or those with inadequate coverage, so your financial situation will be carefully reviewed to determine if you qualify for assistance. ## Insurance Requirements K-PAP is available to patients who are: - **Completely uninsured** (no health insurance coverage) - **Underinsured** (have insurance that does not cover KUVAN or covers it inadequately) If you have commercial insurance, Medicare, or Medicaid, BioMarin's support team will first attempt to work with your insurance to secure coverage. Only if your insurance denies coverage or if coverage is deemed inadequate will you be considered for K-PAP. ## How to Apply for K-PAP ### Step 1: Gather Required Documentation Before starting your application, collect the following documents: - **Valid prescription for KUVAN** from your healthcare provider - **Proof of income** (recent tax return, pay stubs, or benefit statements) - **Proof of residency** (utility bill, lease agreement, or government-issued ID) - **Insurance information** (if applicable) or documentation of lack of insurance - **Completed Physician Enrollment Form** (your doctor will complete this) ### Step 2: Contact BioMarin Patient and Physician Support (BPPS) Reach out to BioMarin's support team to request an application: - **Phone:** 1-877-MY-KUVAN (1-877-695-8826) - **Email:** bpps@BMRN.com - **Hours:** Monday–Friday, 7 AM–4 PM (Pacific Time) You can also work with your healthcare provider's clinic, as they often have application materials available. ### Step 3: Complete the Application Forms You'll need to complete two main forms: **Patient Consent Form (PCF):** This authorizes BioMarin and your healthcare provider to share your medical and insurance information with BioMarin for program eligibility determination. **Patient Enrollment Form (PEF):** This collects your personal, medical, and financial information needed to assess your eligibility. Your healthcare provider will also need to complete and sign the **Physician Enrollment Form**, which includes: - Your diagnosis (PKU) - Medical necessity statement for KUVAN - Current prescription details - Any relevant medical history ### Step 4: Submit Your Application Submit your completed forms and supporting documents to BioMarin: - **Fax:** 1-888-863-3361 or 1-415-520-0548 - **Email:** bpps@BMRN.com - **Phone:** 1-877-695-8826 (to confirm receipt) Ensure all required information is included; incomplete applications may delay processing. ### Step 5: Work with Your Case Manager Once your application is received, a BioMarin Clinical Coordinator or Case Manager will contact you to: - Verify your eligibility - Answer questions about the program - Coordinate with a specialty pharmacy for medication delivery - Provide ongoing support throughout your treatment ## Timeline and Medication Delivery While specific processing timelines are not publicly stated, BioMarin aims to process applications promptly. Once approved, your medication will be shipped directly to you or your healthcare provider through a specialty pharmacy at a date and time convenient for you. Your Case Manager will coordinate all delivery logistics and provide you with tracking information. ## What If Your Application Is Denied? If your application for K-PAP is denied, you have several options: - **Request reconsideration:** Contact your Case Manager to understand the reason for denial and discuss whether additional information could support approval - **Explore alternative assistance:** BioMarin may help identify other coverage options, including state pharmaceutical assistance programs or foundation grants - **Investigate copay assistance:** If you have commercial insurance, manufacturer copay cards or copay assistance programs may reduce your out-of-pocket costs - **Contact patient advocacy organizations:** Organizations supporting patients with PKU and rare metabolic disorders may offer additional financial support ## Reauthorization and Ongoing Support K-PAP assistance requires periodic reauthorization. Your Case Manager will contact you before your current authorization expires to: - Verify that your eligibility status remains unchanged - Update any necessary medical or financial information - Ensure continuous access to your medication It's important to respond promptly to reauthorization requests to avoid gaps in your medication supply. ## Additional Support Services Beyond medication assistance, BioMarin RareConnections provides comprehensive support including: - Guidance on insurance coverage and financial assistance options - Ongoing product support and medication reminders - Coordination with specialty pharmacies for convenient delivery - Connection to PKU resources and community support ## Important Disclaimer This guide provides general information about the KUVAN Patient Assistance Program. Program details, eligibility requirements, and application procedures may change. For the most current and accurate information, contact BioMarin Patient and Physician Support directly at 1-877-695-8826 or visit BioMarin-RareConnections.com. Always consult with your healthcare provider about your treatment options and financial assistance eligibility.

Program information last verified: March 30, 2026