Sample Forms and Letters

Having the right form can help expedite the reimbursement process. Below you’ll find forms you may need for obtaining verification and submitting claims for Cerezyme.

Please contact a Genzyme Case Manager for assistance with the reimbursement process for Cerezyme at 1-800-745-4447, Option 3.

Sample Letters

Statement of Medical Necessity Letter

The Statement of Medical Necessity (SMN) is a form you can use to document a patient’s clinical history of Gaucher disease, diagnosis, signs and symptoms. The SMN allows you to demonstrate that Cerezyme is medically necessary for the treatment of Gaucher disease in a particular patient.

Sample Letter of Intent to Treat

The Letter of Intent (LOI) is a model letter indicating intent to treat a patient living with Gaucher disease with Cerezyme. You may customize it to a patient’s specific requirements.

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, 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).