Mountain State Medical Policy Bulletin
Section: Injections
Number: I-9
Topic: Ceredase/Cerezyme Injections
Effective Date: January 1, 2011
Issued Date: January 3, 2011
Date Last Reviewed:

General Policy Guidelines

Indications and Limitations of Coverage

Ceredase-J0205 and cerezyme (imiglucerase)-J1786 are drugs indicated for use as an enzyme replacement therapy for patients with a confirmed diagnosis and exhibiting signs and symptoms of Type I (adult) Gauchers disease (lipid metabolism disorder).

Coverage for therapeutic injections is determined according to individual or group customer benefits.

Ceredase and cerezyme are indicated for treatment when one or more of the following conditions exists in patients with Type I Gauchers disease:

  • Anemia with hemoglobin of:
    10 grams or less for females
    12 grams or less for males
  • Thrombocytopenia of 50,000 platelets or less and/or documented episodes of thrombocytopenic bleeding
  • Multiple bony lesions involving marrow and/or cortex (must be more than 3 bone lesions in number) and/or pathologic fracture of bone
  • Significant hepatomegaly or splenomegaly in association with thrombocytopenia

NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

J0205J1786    

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

Management of Neutralizing Antibody to Ceredase in a Patient with Type 3 Gaucher Disease, Pediatrics, Official Journal of the American Academy of Pediatrics, Vol. 100, No. 5, 12/1997

Gaucher Disease: Recommendations on Diagnosis, Evaluation, and Monitoring, Archives Internal Medicine, Vol. 158, No. 16, 09/1998

Cardiac Response to Enzyme-Replacement Therapy in Gaucher's Disease, The New England Journal of Medicine, Vol. 339, No. 16, 10/1998

Cessation of Enzyme Replacement Therapy in Gaucher Disease, Genetic Medicine, Vol. 4, No. 6, 11/2002

Ceredase® (alglucerase injection) drug label, Genzyme Corporation, Cambridge, MA, 10/2004

Cerezyme® (imiglucerase for injection) drug label, Genzyme Corporation, Cambridge, MA, 04/2005

Superior Effects of High-Dose Enzyme Replacement Therapy in Type I Gaucher Disease on Bone Marrow Involvement and Chitotriosidase Levels: A 2 Center Retrospective Analysis, Blood, Vol. 108, No. 3, 08/2006

The Clinical and Demographic Characteristics of Non-neuronopathic Gaucher Disease in 887 Children at Diagnosis, Archives of Pediatrics & Adolescent Medicine, Vol. 16, No. 6, 10/2006

Low-dose Therapy Trumps High-dose Therapy Again in the Treatment of Gaucher Disease, Blood, Vol. 108, No. 3, 08/2006

Prevalance and Transmission of Gaucher Disease, Accessed May 2, 2008. National Gaucher Foundation, Rockville, MD

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Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.