Medicare Part B Reimbursement
Obtaining reimbursement for Cerezyme varies by payer and setting.
- The Medicare allowable amount for Cerezyme 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).
- The Medicare allowable amount for Cerezyme® (imiglucerase for injection) 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).
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:
- bone disease
- 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).