Automated World Health
L29193
IBRITUMOMAB TIUXETAN (ZEVALIN ®) THERAPY
04/03/2012
Indications and Limitations of Coverage and/or Medical Necessity
• Medicare will consider use of Ibrumomab tiuxetan (Zevalin) as medically reasonable and necessary for the following FDA uses.
o Non-Hodgkin’s Lymphoma (NHL)
o For previously untreated follicular non-Hodgkin’s lymphoma (NHL) in patients who achieve a partial or complete response to first-line chemotherapy.
o For relapsed or refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL) including patients with rituximab refractory follicular (NHL).
• Ibritumomab Tiuxetan (Zevalin ®) therapy is intended and considered to be a single course treatment regime.
o The efficacy, safety, and toxicity of multiple courses of the therapy have not been established and more than one course of treatment is considered not reasonable and necessary.
o In addition, doses of Y-90 Zevalin greater than 32 mCi are considered excessive and are, therefore, not medically necessary.
o This therapy is contraindicated in patients with platelet counts <100,000/mm3.
CPT/HCPCS Codes
For the therapeutic (Y-90 Zevalin) component of the therapy:
79403 RADIOPHARMACEUTICAL THERAPY, RADIOLABELED MONOCLONAL ANTIBODY BY INTRAVENOUS INFUSION
A9543 YTTRIUM Y-90 IBRITUMOMAB TIUXETAN, THERAPEUTIC, PER TREATMENT DOSE, UP TO 40 MILLICURIES
ICD-9 Codes that Support Medical Necessity
HCPCS code A9543
200.00 RETICULOSARCOMA UNSPECIFIED SITE
200.01 RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.02 RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES
200.03 RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.04 RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.05 RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.06 RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES
200.07 RETICULOSARCOMA INVOLVING SPLEEN
200.08 RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.10 LYMPHOSARCOMA UNSPECIFIED SITE
200.11 LYMPHOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.12 LYMPHOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES
200.13 LYMPHOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.14 LYMPHOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.15 LYMPHOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.16 LYMPHOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES
200.17 LYMPHOSARCOMA INVOLVING SPLEEN
200.18 LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.20 BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE
200.21 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.22 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES
200.23 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.24 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.25 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.26 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES
200.27 BURKITT'S TUMOR OR LYMPHOMA INVOLVING SPLEEN
200.28 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.30 MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.31 MARGINAL ZONE LYMPHOMA,LYMPH NODES OF HEAD, FACE, AND NECK
200.32 MARGINAL ZONE LYMPHOMA,INTRATHORACIC LYMPH NODES
200.33 MARGINAL ZONE LYMPHOMA, INTRAABDOMINAL LYMPH NODES
200.34 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.35 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.36 MARGINAL ZONE LYMPHOMA, INTRAPELVIC LYMPH NODES
200.37 MARGINAL ZONE LYMPHOMA, SPLEEN
200.38 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
200.47 MANTLE CELL LYMPHOMA, SPLEEN
200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.50 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.51 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.52 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRATHORACIC LYMPH NODES
200.53 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.54 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.55 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.56 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRAPELVIC LYMPH NODES
200.57 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, SPLEEN
200.58 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.60 ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.61 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.62 ANAPLASTIC LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
200.63 ANAPLASTIC LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.64 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.65 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.66 ANAPLASTIC LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
200.67 ANAPLASTIC LARGE CELL LYMPHOMA, SPLEEN
200.68 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.70 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.75 LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.76 LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
200.77 LARGE CELL LYMPHOMA, SPLEEN
200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.80 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE
200.81 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.82 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES
200.83 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.84 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.85 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.86 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES
200.87 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING SPLEEN
200.88 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.00 NODULAR LYMPHOMA UNSPECIFIED SITE
202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES
202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES
202.07 NODULAR LYMPHOMA INVOLVING SPLEEN
202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE
202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES
202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES
202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN
202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES
Diagnoses that Support Medical Necessity
See ICD-9 Codes that Support Medical Necessity.
Documentation Requirements
• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of this therapy by clearly indicating the condition for which this drug is being used.
• This documentation is usually found in the history and physical, pathology report or in the office/progress notes.
• The patient’s weight and platelet count, as well as an explanation of the lymphoma type and previous treatment(s), should also be maintained in the medical record.
Utilization Guidelines
• Refer to the FDA prescribing information for appropriate dosing and administration schedules.
Treatment Logic
• Ibritumomab tiuxetan (Zevalin®) is an immunoconjugate resulting from a bond between the monoclonal antibody ibritumomab and the linker-chelator tiuxetan.
Sources of Information and Basis for Decision
Food and Drug Administration (FDA) drug label for Zevalin®, 2011.
IDEC Pharmaceuticals Corporation. (2002). Package insert. This document was utilized to determine the indications and limitations of coverage.
Spectrum Pharmaceuticals (2009). Zevalin prescribing information.
Witzig, T., Gordon, L., Cabanillas, F., et al. (2002). Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patient with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma. Journal of Clinical Oncology 20(10), 2453-2463. This article supports the appropriate indications for this therapy.
Zevalin Prescribing Information (March 2008). Cell Therapeutics, Inc.
04/03/2012
The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.
AMA CPT / ADA CDT Copyright Statement
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