Medicare Coverage
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.
Note:
- 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:
- anemia
- thrombocytopenia
- bone disease
- hepatomegaly or splenomegaly
Important Safety Information
Approximately 15% of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6% of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension.
Reactions related to Cerezyme administration have been reported in less than 15% of patients. Each of the following events occurred in less than 2% of the total patient population. Reported adverse events include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of injection.
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).