Lumizyme® (alglucosidase alfa) treatment is generally covered by the U.S. Medicare program, as long as it is considered medically necessary. However, an individual patient's 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 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:
Be sure to confirm the patient's eligibility under Medicare Part B prior to ordering Lumizyme.
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.
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 benefit. Because of the complexity and variability of Medicare Part D prescription drug coverage, we advise you to contact the PDP or MA-PDto 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.
LUMIZYME® (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (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 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 immune-mediated reactions involving skin and other organs. If immune-mediated reactions occur, consider discontinuation of the administration of alglucosidase alfa, and initiate appropriate medical treatment.
Risk of Acute Cardiorespiratory Failure: Patients with acute underlying respiratory illness or compromised cardiac and/or respiratory function may be at risk of serious exacerbation of their cardiac or respiratory compromise during infusions. Appropriate medical support and monitoring measures should be readily available during alglucosidase alfa infusion, and some patients may require prolonged observation times that should be individualized based on the needs of the patient.
Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement: Administration of general anesthesia can be complicated by the presence of severe cardiac and skeletal (including respiratory) muscle weakness. Therefore, caution should be used when administering general anesthesia. Ventricular arrhythmias and bradycardia, resulting in cardiac arrest or death, or requiring cardiac resuscitation or defibrillation have been observed in infantile-onset Pompe disease patients with cardiac hypertrophy during general anesthesia for central venous catheter placement.
Risk of Antibody Development: Patients with infantile-onset Pompe disease should have a cross-reactive immunologic material (CRIM) assessment early in their disease course and be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. CRIM status has been shown to be associated with immunogenicity and patients’ responses to enzyme replacement therapies. There is evidence to suggest that some patients who develop high and sustained IgG antibody titers, including CRIM-negative patients, may experience reduced clinical alglucosidase alfa treatment efficacy.
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 (≥ 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.
Please see the Full Prescribing Information for complete details, including boxed WARNING.