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Cerezyme® (imiglucerase) Access, Billing, and Reimbursement


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Patient Assistance Program

If your patient does not have insurance, or their insurance has denied coverage for Cerezyme, they may be eligible to receive Cerezyme through the Patient Assistance Program (PAP), where free product is provided through Sanofi Cares North America. To see if your patient qualifies, you will need to initiate a CareConnect PAP application. This can be done on paper or online, call the team at 1-800-745-4447, opt. 3, to learn how.

Billing and reimbursement

To bill for Cerezyme therapy, you must use the appropriate codes. The billing procedures may vary according to the site of service or third-party payer guidelines. Please reference this site or call a Sanofi Case Manager for updated billing codes.

In addition to the reimbursement expertise provided by our Sanofi Case Managers, Sanofi also offers a Guide to Cerezyme Billing and Reimbursement to help you through the process.

Cerezyme billing codes

ICD-10-CM    E75.22    Lipidosis (Gaucher Disease)
NDC    58468-4663-1    400 unit vial
HCPCSJ1786    Cerezyme® - injection, imiglucerase, 10 units
CPT-4    96365
96366
Intravenous infusion therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
Each additional hour (List separately in addition to primary procedure code, 96365)
   Revenue260
261
258
636
General IV therapy service
Infusion pump
IV solutions
Drugs and biologicals requiring a HCPCS code

The unique J-code assigned to Cerezyme, significantly streamlines the reimbursement process. Cerezyme is eligible for reimbursement by commercial payers and Medicare. However, specific policies vary across insurers and from plan to plan.

Providers are responsible for the selection of appropriate codes. Information in the table above provides a general framework for understanding possible coding alternatives. It should not be used as a substitute for a healthcare professional’s own judgment. Any specific guidance or direction regarding claims submission offered by the payer supersedes the information below.

Since third party payers evaluate treatment based on medical necessity, expected outcome, and cost, they generally require documentation of diagnosis and clinical symptoms of Gaucher disease type 1. Refer to the Statement of Medical Necessity sample. This information may need to be submitted with the claim; for specific requirements, check with the payer or contact your Sanofi Case Manager.

To help avoid potential problems obtaining reimbursement, the treating physician should request written confirmation of coverage from the third party payer prior to initiation of enzyme replacement therapy. Sanofi Case Managers can assist in obtaining written authorization for Cerezyme treatment.

For more information, contact Sanofi Support Services at 1‑800‑745‑4447, option 3.

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Indication

Indication and Usage:

Cerezyme® (imiglucerase) for injection is indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions:

  • anemia
  • thrombocytopenia
  • bone disease
  • hepatomegaly or splenomegaly

Important Safety Information

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue CEREZYME and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis, and to seek immediate medical care should symptoms occur.

Warnings and Precautions:

Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.
Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Consider periodic monitoring during the first year of treatment for lgG antibody formation.

Consider risks and benefits of readministering Cerezyme to individual patients following a severe reaction. Consider reducing the rate of infusion, pretreat with antihistamines and/or corticosteroids, and monitor patients for new signs and symptoms of a severe hypersensitivity reaction.

Infusion-Associated Reactions:
Infusion associated reactions (IARs) have been observed in patients treated with Cerezyme. If an IAR occurs, decreasing the infusion rate, temporarily stopping the infusion and/or administering antihistamines and/or antipyretics may ameliorate the symptoms. Closely monitor patients who have experienced IARs when re-administering Cerezyme.

Adverse Reactions:
Adverse reactions reported in adults include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting.

Adverse reactions reported in pediatric patients 2 years of age and older are similar to adults.

Please see full Prescribing Information, including Boxed WARNING.

Indication

Important Safety Information

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