PALYNZIQ

Indicated For

Phenylketonuria (PKU)

About This Medication

# PALYNZIQ Co-Pay Assistance Program Patient Guide: How to Get PALYNZIQ (pegvaliase-pqpz) at Low or No Cost PALYNZIQ (pegvaliase-pqpz) is a prescription injection used to help lower blood phenylalanine (Phe) levels in adults with phenylketonuria (PKU), a rare genetic disorder that affects how the body processes protein[1][2][9]. This patient-friendly guide explains BioMarin Pharmaceutical Inc.'s **PALYNZIQ Co-Pay Assistance Program**, which helps eligible commercially insured patients pay as little as $0 for their PALYNZIQ prescriptions and related auto-injectable epinephrine, up to $18,200 per year[2][3][7]. ## About PALYNZIQ and Living with PKU Phenylketonuria (PKU) is a condition where your body can't break down phenylalanine (Phe), an amino acid found in many foods, leading to high Phe levels that can harm the brain if not managed[2][9]. **PALYNZIQ** is an enzyme substitute given as a daily subcutaneous injection to reduce these levels in adults whose Phe remains uncontrolled despite diet and other treatments[1][10]. Important: PALYNZIQ carries a risk of **anaphylaxis** (a severe allergic reaction), so it's only available through the **PALYNZIQ REMS** (Risk Evaluation and Mitigation Strategy) program. Your doctor must counsel you on this risk, prescribe auto-injectable epinephrine (like EpiPen®), and certify in REMS before you start[1][3][5][6]. BioMarin reports that 97% of insured patients get coverage, and over 82% of prior authorizations are approved on the first try[2]. Nearly 99% of program participants pay $0 out-of-pocket[3][8]. ## Who Qualifies for the Program? This is a **co-pay assistance program** for **commercially insured patients** (private insurance like employer plans or marketplace plans), *not* free medication for uninsured or government-insured individuals[2][7]. Key eligibility: - Valid PALYNZIQ prescription for FDA-approved use (adults with PKU)[2][7]. - Active commercial insurance covering PALYNZIQ[2]. - Prescription *not* reimbursed by federal/state programs (e.g., Medicare, Medicaid, VA, Tricare, state drug assistance)[2][7]. - U.S. or Puerto Rico resident[2]. **No income thresholds** are specified—eligibility focuses on insurance type, not household income[2][7]. The program covers co-pays for PALYNZIQ and up to 3 fills/year of auto-injectable epinephrine (excludes CA and MA residents for epinephrine)[2]. It lasts as long as you're on therapy, up to the $18,200 annual max[2][3]. ## Income Eligibility Breakdown Unlike free drug programs, this co-pay program has **no income limits**. It's designed for insured patients facing high co-pays/deductibles. Here's a simple table: | Household Size | Income Threshold | FPL % | Notes | |---------------|------------------|-------|-------| | Individual | None | None | Commercial insurance required[2][7] | | Couple | None | None | No federal/state program coverage[2] | | Family of 3 | None | None | Up to $18,200/year co-pay help[2] | | Family of 4 | None | None | Excludes premiums, non-BioMarin products[2] | ## Insurance Requirements You **must have commercial insurance**—government programs disqualify you[2][7]. BioMarin RareConnections™ case managers help with prior authorizations (high success rate: 82% first-try approval)[2][3]. If uninsured or cash-pay, you won't qualify; explore other options like patient assistance foundations (not detailed here)[2]. Medicare/Medicaid patients are ineligible[2][7]. Your plan can't reimburse costs covered by the program, and you must report assistance if required[2]. ## Step-by-Step Application Process 1. **Get Prescribed**: See a certified PALYNZIQ REMS prescriber. They'll counsel you on anaphylaxis risks, enroll you in REMS, and prescribe PALYNZIQ + epinephrine[1][5][6][10]. 2. **Contact BioMarin RareConnections**: Call **1-833-PKU-CARE (1-833-758-2273)**. A case manager assesses eligibility, explains benefits, and starts enrollment[2][3][4]. 3. **Complete Forms**: Fill out the **Patient Enrollment Form (PEF)** and **Patient Consent Form (PCF)**. Your doctor submits these[8]. No extensive documents listed; mainly prescription and insurance proof[2]. 4. **Insurance Verification**: Case manager verifies coverage, handles prior auth if needed[3]. 5. **Pharmacy Coordination**: Prescription goes to a specialty pharmacy for home delivery. Provide member ID for epinephrine at any pharmacy[2][3]. Enrollment is phone-based—quick and personalized[2][4]. ## Timeline and Delivery - **Processing**: Varies; case managers coordinate quickly. Prior auths often approve fast (82% first try)[2]. Expect support from enrollment to first dose. - **Delivery**: Specialty pharmacy ships PALYNZIQ to your home. Epinephrine via retail/specialty pharmacy[2][3]. - **Refills**: Automatic via case manager coordination; program covers ongoing co-pays up to annual max[2]. Track via phone support[3]. ## Alternatives if Denied or Ineligible - **Appeal Insurance Denial**: Case managers assist with appeals (97% coverage rate)[2][3]. - **Government Insurance**: If Medicare/Medicaid, ineligible here—check state PKU programs or foundations like the National PKU Alliance. - **Uninsured**: Explore BioMarin general patient assistance (call to inquire) or nonprofits. No biosimilars available[ ]. - **Switch Therapies**: Discuss KUVAN® (another BioMarin PKU drug with similar co-pay program) or diet management with your doctor[7]. ## Disclaimer This guide summarizes info from BioMarin sources as of available data[1][2][3]. Programs can change/terminate without notice[2]. Not health/insurance advice—consult your doctor, insurer, or call 1-833-PKU-CARE for personalized details. Eligibility not guaranteed. Program not insurance; can't combine with other offers. Report assistance to insurer if required[2][7]. For full terms, contact BioMarin.

Program information last verified: March 29, 2026