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Co-Pay Assistance

Check eligibility for a BioMarin Co-Pay Assistance Program

You may be eligible to receive financial assistance with out-of-pocket co-pay expenses related to your BioMarin treatment. This out-of-pocket expense is determined by your insurance company based on plan coverage. BioMarin Co-Pay Assistance Programs are for commercially insured patients only, and certain terms and conditions may apply. If you qualify, the Co-Pay Assistance Programs may reduce your out-of-pocket responsibility and you will need to confirm your eligibility annually.

To be eligible for BioMarin Co-Pay Assistance Programs, you must be a resident of one of the 50 U.S. states or Puerto Rico.

Additionally, BioMarin Co-Pay Assistance Programs are valid for commercially insured patients only. To be eligible, you must not be insured by a publicly funded health program such as Medicare, Medicaid, Veterans Affairs (VA), the Department of Defense (DoD or TRICARE), or any similar state-funded or federally funded program such as state pharmacy assistance programs.

BioMarin Co-Pay Assistance Programs are available only for BRINEURA® (cerliponase alfa), KUVAN® (sapropterin dihydrochloride), PALYNZIQ® (pegvaliase-pqpz), and VOXZOGO® (vosoritide). If you are interested in financial assistance options for other BioMarin products, please contact BioMarin RareConnectionsTM by email or call 1-866-906-6100.

Determine your eligibility by starting your enrollment in a co-pay program

Please answer the following questions to apply for a BioMarin Co-Pay Assistance Program. Provide complete and detailed information to ensure prompt review and processing of your application. Your information will be reviewed, and a dedicated BioMarin RareConnections™ Case Manager will contact you to discuss your eligibility and enrollment.

The BRINEURA Co-Pay Assistance Program provides financial assistance to eligible patients. It covers out-of-pocket co-pay costs for treatment with and/or administration of BRINEURA, up to the annual maximum benefit of $15,750. The BRINEURA Co-Pay Assistance Program applies only to co-pay costs related to BRINEURA and/or administration of BRINEURA and will not cover any costs related to BRINEURA beyond the annual maximum benefit. The program does not cover out-of-pocket costs for your insurance premiums, transportation costs for clinic visits, or any co-pays related to clinic visits or lab tests.

To be eligible for the BRINEURA Co-Pay Assistance Program, you must have a prescription for BRINEURA for an FDA-approved indication and be a resident of one of the 50 U.S. states or Puerto Rico. Additionally, the program is valid only for patients with commercial prescription insurance coverage for BRINEURA who meet eligibility criteria. This means that your prescription cannot be reimbursed (in whole or in part) by any federal, state, or government-funded health insurance program such as Medicare, Medicare Advantage, Medigap, Medicaid, Veterans Affairs (VA), the Department of Defense (DoD) or TRICARE. This program is also not open to cash-paying patients, where product is not covered (or is excluded) by patient’s commercial insurance, or where your plan reimburses you for the entire cost of BRINEURA and its administration. If you live in certain states (MA, MI, MN, or RI), you are not eligible for drug administration co-pay support. This program is subject to termination or modification at any time.

*Indicates a required field.

Patient Information

Patient Contact Information

Are you a resident of one of the 50 U.S. states or Puerto Rico?*

Is your BRINEURA prescription for an FDA-approved indication?*

Is any part of your BRINEURA prescription covered (in whole or in part) by any of the following: (1) federal government-funded health program, such as Medicare (B and/or Part D), Medicare Advantage, Medigap, Medicaid, Veterans Affairs (VA), Department of Defense (DoD) or TRICARE, or (2) any similar state-funded program, such as a state pharmacy assistance program?*

Are you a resident of Massachusetts, Michigan, Minnesota, or Rhode Island?*

Verification

Please provide your initials below to confirm that you have provided complete and accurate information in your application.

Disclosures:

In order to receive benefits under a BioMarin Co-Pay Assistance Program, it is important that you provide complete and accurate information. Your personal information is required for security purposes and is only used to confirm your eligibility for enrollment in the BioMarin Co-Pay Assistance Program and to administer the program.

BioMarin’s Co-Pay Assistance Programs are not open to patients whose prescription is covered by federal, state, or government-funded insurance programs (for example, Medicare, Medicare Advantage, Medigap, Medicaid, VA, DoD or TRICARE), or where prohibited by law. Should you at any time begin receiving prescription drug coverage under such a government-funded program, you will no longer be eligible to participate in the BioMarin Co-Pay Assistance Program and must notify BioMarin immediately.

Indication and Important Safety Information

What is Brineura?

Brineura® (cerliponase alfa) is a prescription medication used to slow loss of ability to walk or crawl (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Who should not take Brineura?
  • Patients with active intraventricular access device-related complications (eg, leakage, device failure, or device-related infection, including meningitis)
  • Patients with any sign or symptom of acute or unresolved localized infection around the device insertion site (eg, cellulitis or abscess) or suspected or confirmed central nervous system (CNS) infection (eg, cloudy cerebrospinal fluid [CSF] or positive CSF gram stain, or meningitis)
  • Patients with shunts used to drain extra fluid around the brain

What is the most important information I should know about Brineura?

Administration: Brineura is only given by infusion into the fluid of the brain (known as an intraventricular injection) and using sterile technique to reduce the risk of infection. An intraventricular access device or port must be in place at least 5 to 7 days prior to the first infusion.

  • Prior to administration, it is important to discuss your child’s medical history with their doctor
  • Tell the doctor if they are sick or taking any medication and if they are allergic to any medicines

Meningitis and other device-related infections: Intraventricular access device-related infections, including meningitis, were observed with Brineura treatment. Infections required treatment with antibiotics and removal of the access device. If any signs of infection or meningitis occur, contact your child’s doctor immediately. The signs and symptoms of infections may not be readily apparent in patients with CLN2 disease.

  • Your child’s doctor should vigilantly be looking for signs and symptoms of infection, including meningitis, during treatment with Brineura
  • Your child’s doctor should inspect the scalp and collect samples of your child’s CSF prior to each infusion of Brineura, to check for infections and that there is no device failure
  • Signs of infection on or around the device insertion site may include redness, tenderness, or discharge

Device-related complications such as device leakage, device failure, extravasation of CSF fluid, or bulging of the scalp around or above the intraventricular access device have occurred. In case of intraventricular access device-related complications, Brineura infusions may be discontinued.

Material degradation of the intraventricular access device reservoir was reported after approximately 4 years of administration, which may impact the effective and safe use of the device. During testing such material degradation was recognized after approximately 105 perforations of the intraventricular access device. The intraventricular access device should be replaced prior to 4 years of single-puncture administrations, which equates to approximately 105 administrations of Brineura.

Cardiovascular side effects: Low blood pressure and/or slow heart rate may occur during and following the infusion of Brineura. Contact your child’s healthcare provider immediately if these reactions occur. As part of the infusion, the healthcare provider will monitor vital signs (blood pressure, heart rate) before infusion starts, periodically during infusion, and post-infusion, and assess the patient’s status after administration to determine if continued observation may be necessary. Additional monitoring is required for patients with a history of cardiac abnormalities. In patients without cardiac abnormalities, regular 12-lead electrocardiogram (ECG) evaluations should be performed every 6 months.

Hypersensitivity reactions including serious and severe allergic reactions (anaphylaxis) may occur. Symptoms of anaphylaxis may include fever, respiratory distress, rash, vomiting, and irritability, and may occur during treatment or within several hours of Brineura infusion. Seek immediate medical care should signs and symptoms of anaphylaxis occur. Your child may receive medication such as antihistamines before Brineura infusions to reduce the risk of reactions.

If anaphylaxis occurs, you and your child’s healthcare providers should consider the risks and benefits of readministration of Brineura. If the decision is made to readminister Brineura after the occurrence of anaphylaxis, the healthcare providers should ensure appropriately trained personnel and equipment for emergency resuscitation (including epinephrine and other emergency medicines) are readily available during infusion and will start the subsequent infusion at approximately one-half the initial infusion rate at which the anaphylactic reaction occurred.

The most common side effects reported during Brineura infusions included:

  • Fever, problems with the electrical activity of the heart, decreased or increased protein in the fluid of the brain, vomiting, seizures, device-related complications, hypersensitivity, collection of blood outside of blood vessels (hematoma), headache, irritability, increased white blood cell count in the fluid of the brain, device-related infection, slow heart rate, feeling jittery, and low blood pressure

The risk information provided here is not comprehensive. Talk to your healthcare provider to learn more or for medical advice about any side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here to see full Prescribing Information or visit www.Brineura.com.

Indication and Important Safety Information

What is Brineura?

Brineura® (cerliponase alfa) is a prescription medication used to slow loss of ability to walk or crawl (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Who should not take Brineura?
  • Patients with active intraventricular access device-related complications (eg, leakage, device failure, or device-related infection, including meningitis)
  • Patients with any sign or symptom of acute or unresolved localized infection around the device insertion site (eg, cellulitis or abscess) or suspected or confirmed central nervous system (CNS) infection (eg, cloudy cerebrospinal fluid [CSF] or positive CSF gram stain, or meningitis)
  • Patients with shunts used to drain extra fluid around the brain

What is the most important information I should know about Brineura?

Administration: Brineura is only given by infusion into the fluid of the brain (known as an intraventricular injection) and using sterile technique to reduce the risk of infection. An intraventricular access device or port must be in place at least 5 to 7 days prior to the first infusion.

  • Prior to administration, it is important to discuss your child’s medical history with their doctor
  • Tell the doctor if they are sick or taking any medication and if they are allergic to any medicines

Meningitis and other device-related infections: Intraventricular access device-related infections, including meningitis, were observed with Brineura treatment. Infections required treatment with antibiotics and removal of the access device. If any signs of infection or meningitis occur, contact your child’s doctor immediately. The signs and symptoms of infections may not be readily apparent in patients with CLN2 disease.

  • Your child’s doctor should vigilantly be looking for signs and symptoms of infection, including meningitis, during treatment with Brineura
  • Your child’s doctor should inspect the scalp and collect samples of your child’s CSF prior to each infusion of Brineura, to check for infections and that there is no device failure
  • Signs of infection on or around the device insertion site may include redness, tenderness, or discharge

Device-related complications such as device leakage, device failure, extravasation of CSF fluid, or bulging of the scalp around or above the intraventricular access device have occurred. In case of intraventricular access device-related complications, Brineura infusions may be discontinued.

Material degradation of the intraventricular access device reservoir was reported after approximately 4 years of administration, which may impact the effective and safe use of the device. During testing such material degradation was recognized after approximately 105 perforations of the intraventricular access device. The intraventricular access device should be replaced prior to 4 years of single-puncture administrations, which equates to approximately 105 administrations of Brineura.

Cardiovascular side effects: Low blood pressure and/or slow heart rate may occur during and following the infusion of Brineura. Contact your child’s healthcare provider immediately if these reactions occur. As part of the infusion, the healthcare provider will monitor vital signs (blood pressure, heart rate) before infusion starts, periodically during infusion, and post-infusion, and assess the patient’s status after administration to determine if continued observation may be necessary. Additional monitoring is required for patients with a history of cardiac abnormalities. In patients without cardiac abnormalities, regular 12-lead electrocardiogram (ECG) evaluations should be performed every 6 months.

Hypersensitivity reactions including serious and severe allergic reactions (anaphylaxis) may occur. Symptoms of anaphylaxis may include fever, respiratory distress, rash, vomiting, and irritability, and may occur during treatment or within several hours of Brineura infusion. Seek immediate medical care should signs and symptoms of anaphylaxis occur. Your child may receive medication such as antihistamines before Brineura infusions to reduce the risk of reactions.

If anaphylaxis occurs, you and your child’s healthcare providers should consider the risks and benefits of readministration of Brineura. If the decision is made to readminister Brineura after the occurrence of anaphylaxis, the healthcare providers should ensure appropriately trained personnel and equipment for emergency resuscitation (including epinephrine and other emergency medicines) are readily available during infusion and will start the subsequent infusion at approximately one-half the initial infusion rate at which the anaphylactic reaction occurred.

The most common side effects reported during Brineura infusions included:

  • Fever, problems with the electrical activity of the heart, decreased or increased protein in the fluid of the brain, vomiting, seizures, device-related complications, hypersensitivity, collection of blood outside of blood vessels (hematoma), headache, irritability, increased white blood cell count in the fluid of the brain, device-related infection, slow heart rate, feeling jittery, and low blood pressure

The risk information provided here is not comprehensive. Talk to your healthcare provider to learn more or for medical advice about any side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here to see full Prescribing Information or visit www.Brineura.com.