Reimbursement Practices

Reimbursement rates, policies, and procedures for Lumizyme® (alglucosidase alfa) therapy vary by payer as well setting of treatment (e.g., in a physician's office versus outpatient setting like a hospital or infusion center). Following are some general practices you may encounter across different insurers; however, these guidelines are not comprehensive and are subject to change. You are advised to contact the insurer directly for the most up-to-date details on their reimbursement practices.

Private Payers, Managed Care, and Medicaid Managed Care

Physician's Office

  • Reimbursement for office-administered drugs is often based on Average Wholesale Price (AWP) or Average Sales Price (ASP)
  • Reimbursement for services varies, depending on the negotiated rate between the provider and insurance company or the insurance company’s fee schedule

Hospital Outpatient Setting

Reimbursement varies depending on the negotiated rate between the hospital and insurance company or the insurance company’s fee schedule

Medicare Part B

Physician's Office

  • The Medicare allowable amount for Lumizyme is Average Sales Price (ASP) plus 6%. Rates are updated quarterly
  • Medicare covers 80% of the allowable amount, and the beneficiary or their supplemental policy is responsible for the remaining 20%
  • Reimbursement for physician services is based upon the Medicare Physician Fee Schedule (MPFS)

Hospital Outpatient Setting

  • The Medicare allowable amount for Lumizyme is Average Sales Price (ASP) plus 6%; rates are updated quarterly
  • Medicare covers 80% of the allowable amount, and the beneficiary or their supplemental policy is responsible for the remaining 20% balance; however, in this site of service, the patient’s 20% coinsurance liability is limited to the current year’s Part A deductible dollar amount [Section 1833(t)(8)(C) of the Social Security Act]
  • Medicare pays 80% of the allowable amount plus any additional amount remaining on the beneficiary’s 20% coinsurance when the limitation on the coinsurance applies [Section 1833(t)(4)(C)]
  • Reimbursement for services is based upon the Ambulatory Payment Classification(APC)

Medicaid

Physician's Office and Hospital Outpatient Setting

  • Reimbursement varies from state-to-state
  • For more information, contact your local Medicaid Office

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