Medicaid Coverage

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 Cerezyme® will need to be considered medically necessary in order to be covered under the Medicaid program. Depending on the state, initial treatment with Cerezyme may require prior approval by the state Medicaid program. For information on Medicaid coverage for Cerezyme® in your state, contact your local Medicaid office or your Genzyme Case Manager.

Medicaid agencies may require the following:

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. 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 Cerezyme 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 Cerezyme in your state, contact the Medicaid Managed Care plan or your Genzyme Case Manager.

Indication & Usage

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

  1. anemia
  2. thrombocytopenia
  3. bone disease
  4. hepatomegaly or splenomegaly

Important Safety Information

Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.

Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.

In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.

Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.

To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch

Please see Full Prescribing Information (PDF).