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Frequently asked questions

Your Case Manager will guide you every step of the way through your treatment journey, working one-to-one with you to address your unique needs related to treatment. Below are some common questions and answers that might be helpful for you.
BioMarin RareConnections is a program that provides a wide array of support services for BioMarin products to help you understand insurance coverage and gain access to treatment. This may include providing information about financial assistance options and working with your healthcare team to coordinate delivery of BioMarin products for your treatment.
BioMarin RareConnections Case Managers provide families with:
  • Personalized support—individualized, one-to-one assistance to start and continue their VIMIZIM® (elosulfase alfa) or NAGLAZYME® (galsulfase) therapy
  • Financial navigation support—navigating the insurance process and understanding coverage options to gain access to treatment
  • Logistics support—coordinating with a specialty pharmacy for delivery of the medication to the infusion center or home as needed
Learn more about how BioMarin RareConnections can help.
Once you enroll in BioMarin RareConnections, you will be assigned a dedicated experienced Case Manager who understands your unique needs related to access to treatment. Your Case Manager can help you determine your insurance coverage and, if necessary, refer you to financial assistance options for VIMIZIM or NAGLAZYME.
To enroll in BioMarin RareConnections and get connected with your Case Manager, start by completing the Patient Authorization Form (PAF).
In order for BioMarin to assist with its medicines and related care, you will need to provide consent to both your healthcare provider and BioMarin:
  • Your healthcare provider needs your written consent to release your protected health information (PHI) to BioMarin
  • BioMarin also needs your written consent to share your information (including genetic information) with other providers to assist you with accessing services that support your treatment
Once you give consent, your healthcare provider will provide BioMarin with the information from your medical records needed to enroll you in BioMarin RareConnections. BioMarin RareConnections will help you work with your insurance provider to get reimbursement for your care and will help you with other case management services.
A patient or an authorized representative for the patient must sign the authorization form.
If you choose not to sign the authorization form, BioMarin will not be able to provide BioMarin RareConnections support in connection with any BioMarin treatment.
BioMarin will use your protected health information (PHI) to enroll you in BioMarin RareConnections, which provides a number of case management services that help support your treatment plan (for example, remind you of appointments or medicine schedules). BioMarin RareConnections will work with you, your healthcare provider, and your health insurance company to help with coverage related to your treatment. If you do not already have insurance coverage, BioMarin RareConnections can help you find insurance options.
The Patient Authorization Form is valid from the date of signature for 10 years, or a shorter time if required by applicable state law, or until you cancel the authorization.
You can cancel the authorization at any time by submitting a written notification to BioMarin RareConnections. Email BioMarin
Connect with a Case Manager by email or call 1-866-906-6100. Once you have been enrolled in BioMarin RareConnections, your dedicated Case Manager will also reach out to you with an introduction and will provide you with their direct contact info. Your Case Manager will be your ongoing partner, providing product support services to help you start and stay on treatment.

Frequently asked questions

Rare diseases can bring uncommon challenges, and everyone’s treatment journey is unique
With BioMarin RareConnections™, you don’t have to face it alone. Your BioMarin team will guide you along your treatment journey, working one-to-one with you to address your unique needs to gain access to treatment. Below are some common questions and answers that might be helpful for you.

About BioMarin RareConnections

BioMarin RareConnections is a program that provides a wide array of support services for BioMarin products to help you understand insurance coverage and gain access to treatment. This may include providing information about financial assistance options and working with your healthcare team to coordinate delivery of BioMarin products for your treatment.

Our dedicated and experienced Case Managers will provide guidance on how you can gain access to BioMarin therapies by:
  • Helping you understand your insurance coverage and financial assistance options
  • Providing you with ongoing product support for BioMarin therapies
  • Coordinating with a specialty pharmacy to deliver your medication at a date and time that is convenient for you
Once you enroll in BioMarin RareConnections, you will be assigned a dedicated experienced Case Manager who understands your unique needs related to treatment. Your Case Manager can help you determine your insurance coverage and, if necessary, identify financial assistance options for your BioMarin treatment.
To enroll in BioMarin RareConnections and get connected with your Case Manager, start by completing the Patient Authorization/Patient Consent Form.
In order for BioMarin to provide product support services, you will need to provide consent to both your healthcare provider and BioMarin:
  • Your healthcare provider needs your written consent to release your protected health information (PHI) to BioMarin
  • BioMarin also needs your written consent to share your information (including genetic testing information) with other providers to assist you with accessing services that support your treatment
Once you give consent, your healthcare provider will provide BioMarin with the information from your medical records needed to enroll you in BioMarin RareConnections. BioMarin RareConnections will help you work with your insurance provider to seek reimbursement for your care and will help you with other case management services.
A patient or an authorized representative for the patient must sign the authorization form.
If you choose not to sign the authorization form, BioMarin will not be able to provide BioMarin RareConnections support in connection with any BioMarin treatment.
BioMarin will use your protected health information (PHI) to enroll you in BioMarin RareConnections, which provides a number of case management services that help support your treatment plan (for example, insurance navigation support). BioMarin RareConnections will work with you, your healthcare provider, and your health insurance company to help with coverage related to your treatment. If you do not already have insurance coverage, BioMarin RareConnections can help you find insurance options.
The Patient Authorization/Patient Consent Form is valid from the date of signature for 10 years, or a shorter time if required by applicable state law, or until you cancel the authorization.
You can cancel the authorization at any time by submitting a written notification to BioMarin RareConnections.

Connect with a Case Manager by email or call 1-866-906-6100. Once you have been enrolled in BioMarin RareConnections, your dedicated Case Manager will also reach out to you with an introduction and will provide you with their direct contact info. Your Case Manager will be an ongoing resource, providing product support services to help you start and continue on treatment.

NAGLAZYME® (galsulfase) Indication and Important Safety Information

VIMIZIM® (elosulfase alfa) Indication and Important Safety Information
WARNING: RISK OF ANAPHYLAXIS

INDICATION

NAGLAZYME® (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

IMPORTANT SAFETY INFORMATION

Severe and life-threatening allergic reactions can occur during NAGLAZYME infusions and up to 24 hours after infusion. Typical signs of an allergic reaction include shock, difficulty breathing, wheezing, swelling of the throat, and low blood pressure. If a severe allergic reaction occurs during infusion, the infusion should be stopped immediately, and you should receive medical attention. Contact your doctor or get medical help right away if you develop any severe symptoms after infusion.

In clinical trials, most patients developed antibodies to NAGLAZYME treatment. There was no clear relationship between antibody formation and the safety or effectiveness of NAGLAZYME.

Serious and severe infusion reactions are associated with NAGLAZYME, including hives, chest pain, rash, abdominal pain, difficulty breathing, swelling, fever, and eye irritation. You should receive medication such as antihistamines before NAGLAZYME infusions to reduce the risk of infusion reactions. If an infusion reaction occurs, the infusion should be slowed or stopped, and you may be given additional medication.

The most common side effects of NAGLAZYME seen in clinical trials were rash, pain, hives, fever, itching, chills, headache, nausea, vomiting, abdominal pain and difficulty breathing. The most common side effects requiring medical attention are infusion-related effects.

These are not all of the possible side effects with NAGLAZYME. Talk to your doctor if you have any symptoms that bother you or that do not go away.

NAGLAZYME is a prescription medicine. Before treatment with NAGLAZYME, it is important to discuss your medical history with your doctor. Tell your doctor if you are taking any medication and if you are allergic to any medicines. Your doctor will decide if NAGLAZYME is right for you. If you have questions or would like more information about NAGLAZYME, contact your doctor.

Spinal cord damage may occur due to the natural MPS VI disease process. Signs of spinal cord injury include back pain, loss of bladder and bowel control, numbness, and paralysis. Contact your doctor immediately if you develop any of these symptoms.

Call your doctor for medical advice about side effects. You may report side effects to BioMarin at 1-866-906-6100 and the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see full Prescribing Information.

INDICATION

VIMIZIM® (elosulfase alfa) is indicated for patients with mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

IMPORTANT SAFETY INFORMATION

Life-threatening allergic reactions, known as anaphylaxis, can occur during VIMIZIM infusions. Typical signs of anaphylaxis include cough, rash, throat tightness, hives, flushing, changes in skin color, low blood pressure, shortness of breath, chest pain, and gastrointestinal symptoms such as nausea, abdominal pain, retching, and vomiting. Contact your doctor or get medical help right away if these symptoms occur during or after VIMIZIM infusions. If you have a respiratory illness, you may be at risk for a sudden worsening of your condition, and you may require additional monitoring.

VIMIZIM is a prescription medicine. Before treatment with VIMIZIM, it is important to discuss your medical history with your doctor. Tell your doctor if you are sick or taking any medication and if you are allergic to any medicines. Also tell your doctor if you are pregnant, planning to become pregnant, or are a nursing mother. Your doctor will decide if VIMIZIM is right for you. If you have questions or would like more information about VIMIZIM, contact your doctor.

Anaphylaxis can occur during any VIMIZIM infusion, as early as 30 minutes from the start and up to 3 hours after infusion, and as late into treatment as the 47th infusion. Hypersensitivity reactions have been observed as early as 30 minutes from the start of infusion but as late as 6 days after infusion.

Serious and severe reactions can happen with VIMIZIM treatment, including life-threatening allergic reactions (anaphylaxis), hives, swelling, cough, shortness of breath, and flushing. You should receive medication such as antihistamines before VIMIZIM infusions to reduce the risk of reactions. If a reaction occurs, the infusion should be slowed or stopped and you may be given additional medication. If a severe reaction occurs, the infusion should be stopped immediately and you will receive appropriate medical treatment.

If you have acute febrile or respiratory illness at the time of VIMIZIM infusion, you may be at higher risk of life-threatening complications from hypersensitivity reactions. If you use supplemental oxygen or continuous positive airway pressure (CPAP), you should have it available during your infusion in the event of a sudden reaction, or extreme drowsiness/sleep from antihistamines.

Spinal cord damage may occur due to the natural MPS IVA disease process. Signs of spinal cord injury include back pain, numbness and paralysis, and loss of bladder and bowel control. Contact your doctor immediately if you develop any of these symptoms.

The most common side effects reported during VIMIZIM infusions included fever, vomiting, headache, nausea, abdominal pain, chills, and fatigue. These are not all the possible side effects with VIMIZIM. Talk to your doctor if you have any symptoms that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to BioMarin at 1-866-906-6100 and the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For more information, call BioMarin RareConnectionsTM at 1-866-906-6100.

Please see accompanying full Prescribing Information, including important warning.

NAGLAZYME® (galsulfase) Indication and Important Safety Information

INDICATION

NAGLAZYME® (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

IMPORTANT SAFETY INFORMATION

Severe and life-threatening allergic reactions can occur during NAGLAZYME infusions and up to 24 hours after infusion. Typical signs of an allergic reaction include shock, difficulty breathing, wheezing, swelling of the throat, and low blood pressure. If a severe allergic reaction occurs during infusion, the infusion should be stopped immediately, and you should receive medical attention. Contact your doctor or get medical help right away if you develop any severe symptoms after infusion.

In clinical trials, most patients developed antibodies to NAGLAZYME treatment. There was no clear relationship between antibody formation and the safety or effectiveness of NAGLAZYME.

Serious and severe infusion reactions are associated with NAGLAZYME, including hives, chest pain, rash, abdominal pain, difficulty breathing, swelling, fever, and eye irritation. You should receive medication such as antihistamines before NAGLAZYME infusions to reduce the risk of infusion reactions. If an infusion reaction occurs, the infusion should be slowed or stopped, and you may be given additional medication.

The most common side effects of NAGLAZYME seen in clinical trials were rash, pain, hives, fever, itching, chills, headache, nausea, vomiting, abdominal pain and difficulty breathing. The most common side effects requiring medical attention are infusion-related effects.

These are not all of the possible side effects with NAGLAZYME. Talk to your doctor if you have any symptoms that bother you or that do not go away.

NAGLAZYME is a prescription medicine. Before treatment with NAGLAZYME, it is important to discuss your medical history with your doctor. Tell your doctor if you are taking any medication and if you are allergic to any medicines. Your doctor will decide if NAGLAZYME is right for you. If you have questions or would like more information about NAGLAZYME, contact your doctor.

Spinal cord damage may occur due to the natural MPS VI disease process. Signs of spinal cord injury include back pain, loss of bladder and bowel control, numbness, and paralysis. Contact your doctor immediately if you develop any of these symptoms.

Call your doctor for medical advice about side effects. You may report side effects to BioMarin at 1-866-906-6100 and the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see full Prescribing Information.

VIMIZIM® (elosulfase alfa) Indication and Important Safety Information
WARNING: RISK OF ANAPHYLAXIS

INDICATION

VIMIZIM® (elosulfase alfa) is indicated for patients with mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

IMPORTANT SAFETY INFORMATION

Life-threatening allergic reactions, known as anaphylaxis, can occur during VIMIZIM infusions. Typical signs of anaphylaxis include cough, rash, throat tightness, hives, flushing, changes in skin color, low blood pressure, shortness of breath, chest pain, and gastrointestinal symptoms such as nausea, abdominal pain, retching, and vomiting. Contact your doctor or get medical help right away if these symptoms occur during or after VIMIZIM infusions. If you have a respiratory illness, you may be at risk for a sudden worsening of your condition, and you may require additional monitoring.

VIMIZIM is a prescription medicine. Before treatment with VIMIZIM, it is important to discuss your medical history with your doctor. Tell your doctor if you are sick or taking any medication and if you are allergic to any medicines. Also tell your doctor if you are pregnant, planning to become pregnant, or are a nursing mother. Your doctor will decide if VIMIZIM is right for you. If you have questions or would like more information about VIMIZIM, contact your doctor.

Anaphylaxis can occur during any VIMIZIM infusion, as early as 30 minutes from the start and up to 3 hours after infusion, and as late into treatment as the 47th infusion. Hypersensitivity reactions have been observed as early as 30 minutes from the start of infusion but as late as 6 days after infusion.

Serious and severe reactions can happen with VIMIZIM treatment, including life-threatening allergic reactions (anaphylaxis), hives, swelling, cough, shortness of breath, and flushing. You should receive medication such as antihistamines before VIMIZIM infusions to reduce the risk of reactions. If a reaction occurs, the infusion should be slowed or stopped and you may be given additional medication. If a severe reaction occurs, the infusion should be stopped immediately and you will receive appropriate medical treatment.

If you have acute febrile or respiratory illness at the time of VIMIZIM infusion, you may be at higher risk of life-threatening complications from hypersensitivity reactions. If you use supplemental oxygen or continuous positive airway pressure (CPAP), you should have it available during your infusion in the event of a sudden reaction, or extreme drowsiness/sleep from antihistamines.

Spinal cord damage may occur due to the natural MPS IVA disease process. Signs of spinal cord injury include back pain, numbness and paralysis, and loss of bladder and bowel control. Contact your doctor immediately if you develop any of these symptoms.

The most common side effects reported during VIMIZIM infusions included fever, vomiting, headache, nausea, abdominal pain, chills, and fatigue. These are not all the possible side effects with VIMIZIM. Talk to your doctor if you have any symptoms that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to BioMarin at 1-866-906-6100 and the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For more information, call BioMarin RareConnectionsTM at 1-866-906-6100.

Please see accompanying full Prescribing Information, including important warning.