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 Cerezyme will need to be considered medically necessary in order to be covered under the Medicare program. Cerezyme 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, Cerezyme and all associated supplies and services must be purchased by the physician or hospital. Medicare Part B does not reimburse for Cerezyme if the drug is purchased by the physician and taken to the hospital outpatient department for administration.
- Confirm the patient’s eligibility under Medicare Part B prior to ordering Cerezyme.
- Medicare Part B will not cover Cerezyme 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 Cerezyme (imiglucerase for injection), the Medicare Managed Care Plan must also cover Cerezyme, although prior authorization and other medical management approaches may be required by the managed care plan.
Medicare Part D Prescription Drug Coverage
Cerezyme may be on formulary under the patient’s 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, MAPD or Genzyme Treatment Support for further information.
Note: Medicare Part D reimburses the PDP or MA-PD pharmacy for drug.
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).