Automated World Health
L29087
BORTEZOMIB (VELCADE®)
04/12/2012
Indications and Limitations of Coverage and/or Medical Necessity
Bortezomib is FDA approved for injection for the following indications:
• Treatment of patient with multiple myeloma.
• Treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Bortezomib is covered for its FDA approved indications, as well as for the following off-labeled indications:
• Treatment of relapsed or refractory B-Cell Non-Hodgkin’s lymphoma specifically; follicular lymphoma.
• Induction therapy for multiple myeloma patients in combination with one or more drugs (NCCN, Multiple Myeloma, V.1.2007).
Route of Administration
• Per the National Comprehensive Cancer Network (NCCN) Drugs and Biologicals Compendia the OFF LABEL use of bortezomib for subcutaneous administration (SQ) is indicated for multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.
o Therefore, both IV and SQ administration are allowed for this indication.
CPT/HCPCS Codes
J9041 INJECTION, BORTEZOMIB, 0.1 MG
ICD-9 Codes that Support Medical Necessity
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
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
202.70 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
202.71 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
202.72 PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
202.73 PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
202.74 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
202.75 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.76 PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
202.77 PERIPHERAL T CELL LYMPHOMA, SPLEEN
202.78 PERIPHERAL T CELL LYMPHOMA, 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
203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.02 MULTIPLE MYELOMA, IN RELAPSE
203.10 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.12 PLASMA CELL LEUKEMIA, IN RELAPSE
203.80 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE
238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS
Documentation Requirements
• Documentation in the medical record must support that bortezomib is administered for an indication specified in this LCD and all applicable coverage criteria must be clearly documented.
• When a portion of the drug is discarded, the medical record must clearly show the amount administered and the amount wasted.
• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.
o The physician must state the clinical indications/medical need for using the chemotherapy drug in the order.
• Documentation must be available to Medicare upon request.
• The dose and frequency of administration should be consistent with the FDA product information.
o More than one 3.5 mg single dose vial would not be expected to be billed for each date of service.
o Based on the J9041 code descriptor, 0.1 mg is equal to one billed service.
o Therefore, up to 35 billed services are allowed.
Treatment Logic:
• Bortezomib (Velcade®) is an antineoplastic agent which inhibits the activity of the 26S proteasome.
• It exhibits cytotoxicity to various malignant cells, including myeloma and lymphoma cells.
• Bortezomib is given by intravenous injection (IV).
Sources of Information and Basis for Decision
Compendia-Based Drug Bulletin, Feb. 2008 Update. The Association of Community Cancer Centers. Available online @ http://www.accc-cancer.org.
FCSO LCD 29087, Bortezomib (Velcade®), 04/12/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.
Fisher, R. I., Wilmot, J. P. (2005). Mantle Cell Lymphoma: At Last, Some Hope for Successful Innovative Treatment Strategies. Journal Clinical Oncology, 23(4): 657-658.
Food and Drug Administration (FDA) approval letter NDA 21-602/S-015 and approval label, June 20, 2008.
Goy, A., Hagemeister, F., McLaughlin, P., Pro, B., Romaguera, J. E., & Younes, A. (2005). Phase II Study of Proteosome Inhibitor Bortezomib in Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma. Journal of Clinical Oncology, 23 (4): 667-675.
Moreau, P., Pylypenko, H., Grosicki,S., Karamanesht, L., Leleu, X., Grishunina, M., Rehtman, G., Maslink, Z., Robak, T., Shubina, A., Arnulf, B., Kropff, M., Cavet, J., Esseeltine, D., Feng, H., Girgis, S., Van De Velde, H., Deraedt, W., Harousseau, J., et al. (2011) Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomized, phase 3, non-inferiority study, The Lancet Oncology, 12, (5): 431- 440.
National Comprehensive Cancer Network, Inc. (2006). Multiple Myeloma. NCCN Clinical Practice Guidelines In Oncology – V.1.2007.
NCCN Drugs & Biologicals Compendium. (2011) website for Borezomib (Velcade). National Comprehensive Cancer Network. Retrieved 12/15/11 from http://www.nccn.org/professionals/drug_compendium/mainpage.aspx
O’Connor, O.A., MacGregor-Cortelli, B., Moskowitz, C., Muzzy, J., Stubblefield, M. & Wright, J. (2005). Phase II Clinical Experience With the Novel Proteosome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin’s Lymphoma and Mantle Cell Lymphoma. Journal of Clinical Oncology, 23 (4): 676-684.
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