PALYNZIQ

Indicated For

Phenylketonuria (PKU)

About This Medication

# PALYNZIQ Co-Pay Assistance Program Patient Guide: How to Get PALYNZIQ at Low or No Cost PALYNZIQ (pegvaliase-pqpz) is an injectable enzyme therapy approved by the FDA to help lower blood phenylalanine (Phe) levels in adults and adolescents aged 12 and older with phenylketonuria (PKU), a rare genetic disorder that affects how the body processes protein.[8][9] The **PALYNZIQ Co-Pay Assistance Program** from BioMarin Pharmaceutical Inc. helps eligible, commercially insured patients pay **as little as $0** out-of-pocket for PALYNZIQ and related auto-injectable epinephrine prescriptions, covering up to **$18,200 per calendar year** in co-pays.[1][3][6] ## About PALYNZIQ and PKU Phenylketonuria (PKU) is a lifelong condition where the body cannot break down phenylalanine (Phe), an amino acid found in protein-rich foods like meat, dairy, and grains. High Phe levels can harm the brain, causing intellectual disability, behavioral issues, and other problems if not managed.[9] Traditional PKU management relies on a strict low-Phe diet and medical foods, but many patients struggle to keep Phe levels controlled. **PALYNZIQ** offers a breakthrough: it's the only FDA-approved enzyme substitution therapy for PKU. Administered as daily subcutaneous injections, it replaces the missing enzyme (phenylalanine ammonia lyase) to break down Phe outside the liver, allowing more dietary flexibility while lowering blood Phe levels. Clinical trials like PEGASUS showed statistically significant Phe reductions compared to diet alone.[8] Recently expanded to adolescents 12+, it's especially helpful for teens with family support to ensure adherence.[8] However, PALYNZIQ carries serious risks, including **anaphylaxis** (a life-threatening allergic reaction). That's why it's only available through the **PALYNZIQ REMS** (Risk Evaluation and Mitigation Strategy) program—a restricted distribution system requiring certified prescribers, enrolled patients, and always carrying auto-injectable epinephrine.[2][5][7][9] ## Who Qualifies for the Co-Pay Assistance Program? This program is **not** a free drug program for uninsured patients—it's designed for those with commercial (private) insurance facing high co-pays. Key eligibility criteria include:[1][3][6][10] - A valid PALYNZIQ prescription for an FDA-approved use (adults or adolescents 12+ with PKU). - **Commercial insurance** coverage (e.g., employer plans, marketplace insurance—not government programs). - Prescription **not reimbursed** (even partially) by federal/state programs like Medicare, Medicaid, VA, DoD, TRICARE, or state drug assistance. - Not cash-paying or using coupons where insurance doesn't cover the product. **Income eligibility**: Unlike many patient assistance programs, this co-pay program does **not** have income thresholds or Federal Poverty Level (FPL) limits. It's based purely on insurance type and prescription validity. Over **99% of participating patients** paid $0 out-of-pocket, and **97% of insured patients** secured coverage.[1][3] | Household Size | Income Threshold | Notes | |---------------|------------------|-------| | Individual | None | No FPL or income limits; commercial insurance required.[1] | | Couple | None | Focus on co-pay reduction up to $18,200/year.[6] | | Family of 3 | None | Eligible if privately insured and not on gov't programs.[3] | | Family of 4 | None | Program covers PALYNZIQ + epinephrine co-pays.[1] | ## Insurance Requirements You **must have commercial insurance** prescribing PALYNZIQ. Government programs (Medicare, Medicaid, etc.) disqualify you.[1][6] BioMarin reports **82% prior authorization approval rate** on first try and **97% overall coverage** for insured patients.* Your BioMarin RareConnections Case Manager can help with prior authorizations.[3] **Note**: PALYNZIQ requires REMS enrollment. Your doctor must certify, counsel you on anaphylaxis risks, and prescribe epinephrine.[5][7][9] ## Step-by-Step Application Process 1. **Get Prescribed**: See a REMS-certified prescriber (complete one-time certification via PALYNZIQREMS.com). Discuss PKU control and risks.[2][9] 2. **Enroll in REMS**: Doctor counsels you, enrolls you in PALYNZIQ REMS, and ensures epinephrine prescription. Call 1-855-758-REMS (1-855-758-7367) for questions.[5][9] 3. **Contact BioMarin RareConnections**: Call **1-833-PKU-CARE (1-833-758-2273)** to check eligibility and enroll in the Co-Pay Program. Provide insurance details.[1][4][10] 4. **Complete Forms**: Submit **Patient Consent Form (PCF)** and **Patient Enrollment Form (PEF)**. Case Manager coordinates prior auth, specialty pharmacy orders, and delivery.[3][10] 5. **Receive Medication**: Specialty pharmacy ships PALYNZIQ (refrigerated) and epinephrine. Case Managers track everything.[3] No online application URL specified; phone is primary method.[1] ## Timeline and Delivery - **Processing**: Varies; Case Managers expedite prior auth (high success rate).[3] Expect weeks for full setup including REMS and insurance. - **Delivery**: Direct to your home via specialty pharmacy. Co-pay card activates for $0 fill if eligible (up to annual max).[1][4] - **Refills**: Automatic as long as on therapy and eligible; program lasts calendar year, renews.[1] ## Alternatives if Denied or Ineligible - **No commercial insurance?** Contact BioMarin RareConnections for other options (not detailed here).[4] - **Government insurance?** Program ineligible; explore state PKU programs or generic Phe management. - **Denied co-pay?** Appeal via Case Manager; high approval stats suggest retries work.[3] - **Biosimilars**: None available.[ ] - **Other PKU therapies**: KUVAN (sapropterin) has similar co-pay program (98% pay $0).[6] Dietitian support or clinical trials. ## Important Disclaimer This guide summarizes BioMarin’s PALYNZIQ Co-Pay Assistance Program based on available resources as of 2026. Programs can change, end, or have restrictions—**always verify with 1-833-PKU-CARE**.[1][3] Not legal/medical advice. Consult your doctor for PKU treatment. Co-pay assistance may affect insurance/taxes; report as required. BioMarin reserves right to modify/terminate.[1][6] *Data from BioMarin RareConnections (e.g., 2022-2024).[3][10] Word count: 1028.

Program information last verified: March 30, 2026