Medicare Coverage

Lumizyme® (alglucosidase alfa) treatment is generally covered by the U.S. Medicare program, as long as it is considered medically necessary. However, individual patients' coverage may vary depending on their local Medicare carrier and/or plan administrator.

Medicare coverage for Lumizyme may also vary depending on how and where the treatment is administered to the patient—for example in a physician's office versus in a hospital outpatient setting.

Medicare will not pre-authorize treatment, so before initiating treatment, you and your billing department should understand each patient's policy and coverage and review the guidelines below, as these may affect decisions about how to administer treatment as well as success in obtaining reimbursement.

Medicare Part B: Medical Benefits, Physician's Office and Hospital Outpatient

Medicare Part B coverage is determined by the local Medicare Part B carrier, also known as the A/B Medicare Administrative Contractor (A/B MAC). Lumizyme is generally covered under a patient's Medicare Part B medical benefits when billed as an incident to a physician's professional services. Thus in order to be covered by Part B, Lumizyme and all associated supplies must be purchased by the physician or hospital and infusions administered in the office or hospital outpatient department setting.

Medicare Part B will NOT reimburse for Lumizyme if it is:

  • Purchased by the physician and then taken to a hospital or other outpatient setting for administration
  • Dispensed by retail pharmacies

Be sure to confirm the patient's eligibility under Medicare Part B prior to ordering Lumizyme.

Medicare Part C: Managed Care Plans

In general, Medicare Part C Managed Care plans work like commercial managed care plans and may require prior authorization. While different plans have different guidelines, Medicare Managed Care plans are required by Medicare to provide, at a minimum, the same level of benefits available under the traditional fee-for-service Medicare program. Therefore, if the local Medicare B carrier, or A/B MAC, covers Lumizyme, the Medicare Managed Care Plan must also cover Lumizyme, although prior authorization and other medical management approaches may be required by the managed care plan.

Medicare Part D: Prescription Drug Benefits

Lumizyme may be covered by a patient's Medicare Part D prescription drug benefits if it is listed on the formulary of the patient's Prescription Drug Plan (PDP) or Medicare Advantage Prescription Drug (MA-PD) plan.

The patient's out-of-pocket costs will vary depending on their plan benefits. Because of the complexity and variability of Medicare Part D prescription drug coverage, we advise you to contact the PDP, MA-PD, or Sanofi Genzyme Case Manager (800-745-4447, option 3) to confirm each patient's situation.

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