Sanofi Genzyme is committed to working with healthcare providers, as well as with public and private payers, to help secure access to treatment for patients who may benefit from Lumizyme® (alglucosidase alfa).
Treatment with Lumizyme is a covered benefit under most major insurance plans as well as Medicare and Medicaid. In this section you'll find an overview of Lumizyme coverage under different kinds of insurers, information on potential requirements, and other issues to consider when reviewing your patients' plans.
The information provided here is not comprehensive and is subject to change. Providers ultimately retain responsibility for determining reimbursement and insurance issues related to their patients, so it's important for you to understand the details of your patients' specific coverage and benefits. Sanofi Genzyme is not responsible for failure of a provider to obtain reimbursement.
In addition to the reimbursement expertise provided by CareConnectPSS® Case Managers to patients, Sanofi Genzyme also offers the following downloadable resources to help guide you through the process:
Lumizyme Billing Guide
To bill for Lumizyme therapy, you must use the appropriate codes. The billing procedures may vary according to the site of service or third-party payer guidelines. Please reference this billing guide.
Letter of Intent to Treat
The Letter of Intent (LOI) is a model letter indicating intent to treat a patient living with Pompe disease with Lumizyme. You may customize it to a patient’s specific requirements. See Lumizyme Billing Guide below.
Statement of Medical Necessity
The Statement of Medical Necessity (SMN) is a form you can use to document a patient’s clinical history of Pompe disease, diagnosis, signs and symptoms. The SMN allows you to demonstrate that Lumizyme is medically necessary for the treatment of Pompe disease in a particular patient. See Lumizyme Billing Guide below.
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: Since Lumizyme is a protein, it is possible that patients receiving it develop antibodies. Some patients who develop high IgG antibody levels that last for a while may have reduced response to Lumizyme. 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.
If you are pregnant, you should use Lumizyme only if your doctor has determined that its use outweighs any risks to your unborn child.
Please see the Full Prescribing Information for complete details, including boxed WARNING.