When it comes to long-term therapies like Lumizyme®, understanding your insurance coverage is very important but it can be confusing at times. With 25 years of experience in navigating the reimbursement process for enzyme replacement therapies, CareConnectPSS® Case Managers are knowledgeable and will work with you every step of the way.
Your CareConnectPSS Case Manager can help you and your physician better understand your insurance benefits so you can get access to the treatment you need.
If you currently have health insurance: Your CareConnectPSS Case Manager can help review your coverage options for treatment with Lumizyme and explain how your coverage will work.
If you are currently uninsured or have limited health insurance coverage: Your CareConnectPSS Case Manager can help you review your coverage options and if necessary, educate you on programs that may provide financial assistance for eligible applicants. They can also help provide Lumizyme to eligible individuals through the Sanofi genzyme Charitable Access Program.
If a claim has been denied by your insurance company: Call your CareConnectPSS Case Manager for assistance immediately. It is helpful to have a copy of the denied claim in hand when calling. Your CareConnectPSS Case Manager can help by working with you, your healthcare providers and insurance company to begin an appeal process, if necessary.
For help with insurance questions, please connect with a CareConnectPSS
Case Manager on line at careconnectpss.com or please call:
Option 3, Monday through Friday, 8:00 AM to 6:00 PM EST
A consent form is required for a CareConnectPSS Case Manager to work with you, your health care providers and insurance company. This service is offered at no cost to you and is completely voluntary. Any information you provide will be maintained as confidential by Sanofi Genzyme.
LUMIZYME® (alglucosidase alfa) is an enzyme replacement therapy for patients with Pompe disease (acid α-glucosidase (GAA) deficiency).
WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE
Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide you with immediate medical care. Appropriate medical support and monitoring measures should be available during infusion.
Immune-Mediated Reactions: You or your child may be monitored for the development of systemic immune-mediated reactions while receiving Lumizyme. If these reactions occur, your doctor may discontinue the infusion and initiate appropriate medical treatment.
Risk of Acute Cardiorespiratory Failure: Infant Pompe patients with heart or breathing problems who are experiencing an acute respiratory condition may be at risk for increasing the seriousness of these problems as a result of Lumizyme administration due to the infusion fluid, and your child’s doctor may require additional monitoring for these infants.
Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement: Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for Lumizyme infusion. Ventricular arrhythmias and slow heart rate resulting in cardiac arrest or death have been observed in infant Pompe patients with cardiac hypertrophy during general anesthesia for central venous catheter placement. Appropriate medical support and monitoring measures should be available during infusion.
Risk of Antibody Development: Patients with infantile-onset Pompe disease (IOPD) should be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. Some patients who develop high and sustained IgG antibody levels, including certain IOPD patients, may have a reduced response to Lumizyme.
Monitoring: Laboratory Tests: Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.
The most frequently reported adverse reactions during Lumizyme studies in patients were allergy reactions and included: anaphylaxis, rash, fever, flushing/feeling hot, hives, headache, excessive sweating, nausea, cough, less oxygen in the blood, fast heart rate, rapid breathing, chest discomfort, dizziness, muscle twitching, agitation, bluish or purple skin, redness of skin, high blood pressure/increased blood pressure, facial paleness, chills, tremor, vomiting, fatigue, and muscle pain.
Please see the Full Prescribing Information for complete details, including boxed WARNING.