Coverage Guidelines

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.

Billing Resources

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 our Case Managers, 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 or call a Sanofi Genzyme Case Manager for updated billing codes.

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 above.

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 above.

 

A Sanofi Genzyme Case Manager is only a phone call away, ready to answer questions or provide assistance to your patients. Contact Sanofi Genzyme Support Services at 800-745-4447, option 3, Monday through Friday, 8AM to 6PM EST.

Spanish-speaking Case Managers are available, as well as interpreters for other languages.

 

This page is for informational purposes only and is subject to change. Healthcare professionals are responsible for complying with reimbursement related rules and regulations. Providers are also responsible for the accuracy of any claims, invoices, and related documentation submitted to payers.


INDICATION

LUMIZYME® (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, and RISK OF CARDIORESPIRATORY FAILURE
  • Life-threatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema (including tongue or lip swelling, periorbital edema, and face edema), and urticaria, have occurred in some patients during and after alglucosidase alfa infusions. Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following alglucosidase alfa treatment. Closely observe patients during and after alglucosidase alfa administration and be prepared to manage anaphylaxis and hypersensitivity reactions. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated-reactions and have them seek immediate medical care should signs and symptoms occur.
  • Infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and require additional monitoring.

WARNINGS AND PRECAUTIONS

Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If anaphylaxis or severe hypersensitivity reactions occur, immediately discontinue infusion and institute appropriate medical treatment. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: Monitor patients for the development of systemic immunemediated reactions involving skin and other organs.

Risk of Acute Cardiorespiratory Failure: Patients with acute underlying respiratory illness and compromised cardiac and/or respiratory function may be at risk of acute cardiorespiratory failure. Caution should be exercised when administering alglucosidase alfa to patients susceptible to fluid volume overload. Appropriate medical support and monitoring measures should be available during infusion and some patients may require longer observation times.

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 alglucosidase alfa infusion.

Risk of Antibody Development: As with all therapeutic proteins, there is potential for immunogenicity. There is some evidence to suggest that some patients who develop high and sustained IgG antibody titers may experience reduced clinical efficacy. Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.

ADVERSE REACTIONS

The most frequently reported adverse reactions (≥ 5%) in clinical trials were hypersensitivity reactions and included: anaphylaxis, rash, pyrexia, flushing/feeling hot, urticaria, headache, hyperhidrosis, nausea, cough, decreased oxygen saturation, tachycardia, tachypnea, chest discomfort, dizziness, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, vomiting, fatigue, and myalgia.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, alglucosidase alfa may cause fetal harm.

Please see the Full Prescribing Information, for complete details, including boxed WARNING

Contact Us

Sanofi Genzyme
50 Binney Street
Cambridge, MA 02142

Tel : 617-768-9000
Fax : 617 252 7600
Toll free : 800-745-4447