Fabrazyme Coverage

Private Payers

Fabrazyme treatment is covered by many private payers; however, individual patients’ insurance benefits will vary. A patient’s insurance coverage should be understood before treatment is initiated so that problems obtaining reimbursement may be minimized. Important points related to private payers include:

  • Managed care plans may require a referral from the patient’s primary care provider (PCP) to a specialist.

Private payers may require the following:

  • Prior authorization to establish medical necessity for Fabrazyme.
  • Periodic reauthorization or recertification for continued treatment.
  • Letter of Intent to Treat. 
  • Statement of Medical Necessity.

Note: If the patient’s private insurer denies coverage, an appeal process may be initiated. Sanofi Genzyme Case Managers are available to assist patients and their physicians in this process.

Medicare Part B

Medicare Part B coverage is determined by the local Medicare Part B carrier. Medicare will not prior authorize, so the patient’s coverage policy should be understood before treatment is initiated. Treatment with Fabrazyme will need to be considered medically necessary in order to be covered under the Medicare program. Fabrazyme is generally covered by Medicare Part B when it is administered and billed as incident to a physician’s services. This means that in order for it to be reimbursed, Fabrazyme and all associated supplies and services must be purchased by the physician or hospital.

Note:

  • Confirm the patient’s eligibility under Medicare Part B prior to ordering Fabrazyme.
  • Medicare Part B will not cover Fabrazyme prescriptions dispensed by retail pharmacies.

Medicare Managed Care (Medicare Part C)

In general, Medicare 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 covers Fabrazyme, the Medicare Managed Care Plan must also cover Fabrazyme, although prior authorization and other medical management approaches may be required by the managed care plan.

Medicare Part D Prescription Drug Coverage

Fabrazyme may be on formulary under the patient's medicare Prescription Drug Plan (PDP) or Medicare Advantage Prescription Drug (MA-PD). The patient's out-of-pocket (OOP) costs will vary depending upon plan coverage. Due to the complexity and variability of Medicare Part D prescription drug coverage, contact the PDP, MA-PD or contact a Sanofi Genzyme Case Manager for further information.

Note: Medicare Part D reimburses the PDP or MA-PD pharmacy for drug.

Medicaid

Medicaid eligibility and benefit plans vary from state-to-state, so the program's coverage policy should be understood before treatment is initiated. Usually, treatment with Fabrazyme will need to be considered medically necessary in order to be covered under the Medicaid program. Depending on the state, initial treatment with Fabrazyme may require prior approval by the state Medicaid program. For information on Medicaid coverage for Fabrazyme in your state, contact your local Medicaid office or a Sanofi Genzyme Case Manager.

Medicaid agencies may require the following:

  • Prior authorization to establish medical necessity for Fabrazyme.
  • Periodic reauthorization or recertification for continued treatment.
  • Letter of Intent to Treat.
  • Statement of Medical Necessity.

Note:

  • Medicaid regularly updates patient eligibility. Therefore, prior to each patient encounter, physicians should verify eligibility and coverage.
  • If Medicaid denies coverage, an appeal process may be initiated. Sanofi Genzyme Case Managers are available to assist patients and their physicians with this process.

Medicaid Managed Care

Many states require Medicaid patients to be enrolled in Medicaid Managed Care plans. These plans vary considerably from state-to-state, and have different documentation and coverage requirements. For example, referrals for treatment with Fabrazyme may need to be in place in order for the patient to receive treatment by anyone other than the patient’s primary care provider. For information on Medicaid coverage for Fabrazyme in your state, contact the Medicaid Managed Care plan or a Sanofi Genzyme Case Manager.

Indication and Usage

Fabrazyme® (agalsidase beta) is indicated for use in patients with Fabry disease. Fabrazyme reduces globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types. The reduction of GL-3 inclusions suggests that Fabrazyme may ameliorate disease expression; however, the relationship of GL-3 inclusion reduction to specific clinical manifestations of Fabry disease has not been established.

Important Safety Information

Life-threatening anaphylactic and severe allergic reactions have been observed in patients during Fabrazyme infusions. In clinical trials and postmarketing safety experience, approximately 1% of patients developed anaphylactic or severe allergic reactions during Fabrazyme infusions. Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion. Interventions have included cardiopulmonary resuscitation, oxygen supplementation, IV fluids, hospitalization, and treatment with inhaled beta-adrenergic agonists, antihistamines, epinephrine, and IV corticosteroids. If severe allergic or anaphylactic reactions occur, immediately discontinue administration of Fabrazyme and provide necessary emergency treatment. Because of the potential for severe allergic reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.

  • In patients experiencing infusion reactions, pretreatment with an antipyretic and antihistamine is recommended.
  • Infusion reactions occurred in some patients after receiving pretreatment with antipyretics, antihistamines, and oral steroids.
  • If an infusion reaction occurs, decreasing the infusion rate, temporarily stopping the infusion, and/or administrating additional antipyretics, antihistamines, and/or steroids may ameliorate the symptoms.
  • If severe infusion reactions occur, immediate discontinuation of the administration of Fabrazyme should be considered, and appropriate medical treatment should be initiated.
  • Severe reactions are generally managed with administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen when clinically indicated.
  • Because of the potential for severe infusion reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.

Re-administration of Fabrazyme to patients who have previously experienced severe or serious allergic reactions to Fabrazyme should be done only after careful consideration of the risks and benefits of continued treatment, and only under the direct supervision of qualified personnel and with appropriate medical support measures readily available.

The most common adverse reactions reported are infusion reactions, some of which were severe. Infusion reactions occurred in approximately 50-55% of patients during Fabrazyme administration in clinical trials. Serious and/or frequently occurring (≥ 5% incidence) related adverse reactions consisted of one or more of the following: chills, fever, feeling hot or cold, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, back pain, pallor, bradycardia, urticaria, hypotension, face edema, rash, and somnolence.

  • Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion reactions. Patients with compromised cardiac function should be monitored closely if the decision is made to administer Fabrazyme.
  • Other serious adverse events reported in clinical studies included stroke, pain, ataxia, bradycardia, cardiac arrhythmia, cardiac arrest, decreased cardiac output, vertigo, hypoacousia, and nephrotic syndrome. These adverse events also occur as manifestations of Fabry disease; an alteration in frequency or severity cannot be determined from the small numbers of patients studied.
  • Severe and serious infusion related reactions have been reported in postmarketing experience, some of which were life threatening including anaphylactic shock. In addition to the above adverse reactions, the following have been reported during postmarketing use of Fabrazyme: arthralgia, asthenia, erythema, hyperhidrosis, infusion site reaction, lacrimation increased, leukocytoclastic vasculitis, lymphadenopathy, hypoesthesia, oral hypoesthesia, palpitations, rhinorrhea, oxygen saturation decreased and hypoxia.
  • Adverse reactions (regardless of relationship) resulting in death reported in the postmarketing setting with Fabrazyme treatment included cardiorespiratory arrest, respiratory failure, cardiac failure, sepsis, cerebrovascular accident, myocardial infarction, renal failure, and pneumonia. Some of these reactions were reported in Fabry disease patients with significant underlying disease.

The safety and efficacy in patients younger than 8 years of age have not been evaluated.

Most patients who develop IgG antibodies do so within the first three months of exposure. IgG seroconversion in pediatric patients was associated with prolonged half-life of Fabrazyme, a phenomenon rarely observed in adult patients.

In clinical trials, a few patients developed IgE or skin test reactivity specific to Fabrazyme. Physicians should consider testing for IgE in patients who experienced suspected allergic reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies.

Fabrazyme is available by prescription only. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1‑800‑FDA‑1088. You may also contact Sanofi Genzyme at 1-800-745-4447, option 2. To learn more, please see the full prescribing information (PDF) or contact Sanofi Genzyme at 1-800-745-4447.