|
Medical Policy: 05.01.18
Original Effective Date: February 2008
Reviewed: January 2012
Revised: January 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Ibritumomab is a murine anti-human antigen CD20 monoclonal antibody conjugated with the chelating agent tiuxetan. Ibritumomab tiuxetan readily chelates the radioisotopes indium 111 and yttrium 90 and is used as a radioimmunotherapeutic agent. After infusion the monoclonal antibody targets the CD20 antigen, which is found on the surface of mature B cells and B-cell tumors. The CD20 antigen is expressed on more than 90 percent of B-cell non-Hodgkin’s lymphomas. In this manner, cytotoxic radiation is delivered directly to malignant tumor cells.
Ibritumomab tiuxetan must be used along with rituximab, another monoclonal antibody that targets malignant B-lymphocytes and been approved for the treatment of low-grade non-Hodgkin’s lymphoma. Ibritumomab tiuxetan is marketed under the trade name Zevalin®.
Until recently, the ibritumomab regimen was administered in two parts. Patients first received rituximab followed by a form of ibritumomab tiuxetan with a low dose of the radioactive chemical Indium-111 for imaging purposes. If the tumors were properly targeted with this imaging procedure, the patient received rituximab again with a form of ibritumomab that has a different radioactive chemical, Yttrium 90, which provides a therapeutic benefit. In November, 2011, The U.S. Food and Drug Administration (FDA) approved the removal of the pretreatment biodistribution evaluation requirement using Indium-111 Zevalin imaging dose followed by gamma scan before administering the Zevalin therapeutic dose. Now patients undergoing treatment with Zevalin will receive the two infusions of rituximab followed by a 10-minute injection of Zevalin. This simplified regimen will now be called “RRZ” – rituximab, rituximab, Zevalin.
Tositumomab is a murine anti-human antigen CD20 monoclonal antibody that covalently binds the radioisotope iodine I 131 and is used as a radioimmunotherapeutic agent. Like ibritumomab tiuxetan, tositumomab targets the CD20 antigen found on the surface of mature B cells and B-cell tumors.
The tositumomab regimen is administered in two steps: the dosimetric and therapeutic steps. Each step consists of a sequential infusion of tositumomab followed by iodine-131 tositumomab. The therapeutic step is administered 7 to 14 days after the dosimetric step. The intent of the dosimetric step is to provide a consistent dose of radiation by adjusting for the individual patient’s rate of clearance of the drug. Those with high tumor burden, splenomegaly, or bone marrow involvement have demonstrated a faster clearance, shorter terminal half-life, and larger volume of distribution.
Tositumomab is marketed under the trade name Bexxar®.
See also policy 06.01.14 Tumor Scintigraphy
 Top
Prior Approval:
Not applicable
Top
Policy:
A single course of tositumomab (Bexxar®) used for the treatment of antigen CD-20-positive, follicular, non-Hodgkin lymphoma, with or without transformation, whose disease is refractory to rituximab and has relapsed following chemotherapy may be considered medically necessary.
A single course of ibritumomab tiuxetan (Zevalin®) used for the treatment of patients with relapsed or refractory CD20-positive low-grade, follicular, or transformed B-cell non-Hodgkin lymphoma, including patients with rituximab-refractory follicular non-Hodgkin lymphoma, may be considered medically necessary.
Tositumomab (Bexxar®) or ibritumomab tiuxetan (Zevalin®) may be considered medically necessary for the initial treatment of follicular lymphoma in patients who are unable to tolerate standard chemotherapy, e.g., elderly or frail patients.
Tositumomab (Bexxar®) or ibritumomab tiuxetan (Zevalin®) may be considered medically necessary for consolidation after chemotherapy in non-Hodgkin lymphoma patients who achieve a partial or complete response.
All other uses of Zevalin® and Bexxar® are considered investigational, including when used as part of a preparatory regimen prior to hematopoietic stem cell transplantation in patients with non-Hodgkin lymphoma.
Top
Procedure Codes and Billing Guidelines:
-
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
-
A9543 Yttrium Y-90 ibritumomab tiuxetan, therapeutic, per treatment dose, up to 40 millicuries
-
A9545 Iodine I-131 tositumomab, therapeutic, per treatment dose
Top
Selected References:
-
Witzig TE, Molina A, Gordon LI et al. Long-term responses in patients with recurring or refractory B-cell non-Hodgkin’s lymphoma treated with yttrium 90 ibritumomab tiuxetan. Cancer. 2007;109(9):1804-1810.
-
Dreyling M, Trumper L et al. Results of a national consensus workshop: therapeutic algorithm in patients with follicular lymphoma- role of radioimmunotherapy. Ann Hematol. 2007;86(2):81-87.
-
Schulz H, Bohlius JF, trelle S et al. Immunochemotherapy with rituximab and overall survival in patients with indolent or mantle cell lymphoma: a systematic review and meta-analysis. J Natl Cancer Inst. 2007;99(9):706-714.
-
Fisher RI, Kaminski MS, Wahl RL et al. Tositumomab and iodine-131 tositumomab produces durable complete remissions in a subset of heavily pretreated patients with low-grade and transformed non-Hodgkin’s lymphoma. J Clin Oncol. 2005;23(30):7565-7573.
-
Fisher RI, Leblanc M, Press OW et al. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol. 2005;23(33):8447-8452.
-
Fietz T, Thiel E. Antibody therapy in non-Hodgkin’s lymphoma: the role of rituximab, 90Y-ibritumomab tiuxetan, and alemtuzumab. Recent Results Cancer Res. 2007;176:153-163.
-
Pohar R, Clark M, Nkansah E. radioimmunotherapies for Non-Hodgkin Lymphoma: Systematic Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines. Ottawa: Canadian Agency for Drugs and technologies in health; 2009.
-
Goff L, Summers K, Iqbal S et al. Quantitative PCR analysis for Bcl-2/IgH in a phase III study of Yttrium-90 Ibritumomab Tiuxetan as consolidation of first remission in patients with follicular lymphoma. J Clin Oncol. 2009 Oct 26. [Epub ahead of print]
-
Morschhauser F, Dreyling M, Rohatiner A et al. Rationale for consolidation to improve progression-free survival in patients with non-Hodgkin’s lymphoma: a review of the evidence. Oncologist 2009; 14(suppl 2):17-29.
-
Gisselbrecht C, Vose J, Nademanee A et al. Radioimmunotherapy for stem cell transplantation in non-Hodgkin’s lymphoma: in pursuit of a complete response. Oncologist 2009; 14(suppl 2):41-51.
-
Devizzi L, Guidetti A, Tarella C et al. High-dose yttrium-90-ibritumomab tiuxetan with tandem stem-cell reinfusion: an outpatient preparative regimen for autologous hematopoietic cell transplantation. J Clin Oncol 2008; 26(32):5175-82.
-
Shimoni A, Zwas S, Oksman Y et al. Ibritumomab tiuxetan (Zevalin) combined with reduced-intensity conditioning and allogeneic stem-cell transplantation (SCT) in patients with chemorefractory non-Hodgkin’s lymphoma. Bone Marrow Transplant 2008; 41(4):355-61.
-
Palanca-Wessels M, Press OW. Improving the efficacy of radioimmunotherapy for non-Hodgkin lymphomas, cancer 2010; 116(4 supple):1126-33.
-
Decaudin D, Mounier N, Tilly H et al. (90) Y ibritumomab tiuxetan (Zevalin) combined with BEAM (Z-BEAM) conditioning regimen plus autologous stem cell transplantation in relapsed or refractory low-grade CD20-positive B-cell lymphoma. A GELA phase II prospective study. CLin Lymphoma Myeloma Leuk. 2011 Apr; 11(2):212-8. Epub 2011 Apr 9.
-
Ria R, Musto P, Reale A et al. 90Y-ibritumumab tiuxetan as consolidation therapy after autologous stem cell transplantation in aggressive non-Hodgkin lymphoma. J Nucl Med. 2011 Jun; 52(6):891-5. Epub 2011 May 13.
-
Guidetti A, Carlo-Stella C, Ruella M et al. Myeloablative doses of yttrium-90-ibritumumab tiuxetan and the risk of secondary myelodysplasia/acute myelogenous leukemia. Cancer. 2011 Nov 15; 117(22):5074-84. doi: 10.1002/cncr.26182. Epub 2011 May 12.
-
Schaefer NG, Huang P, Buchanan JW et al. Radioimmunotherapy in non-Hodgkin lymphoma: opinions of nuclear medicine physicians and radiation oncologists. J Nucl Med. 2011 May; 52(5):830-8.
-
Han EJ, Lee SE, Kim SH et al. Clinical outcomes of post-remission therapy using (90) yttrium ibritumomab tiuxetan (Zevalin®) for high-risk patients with diffuse large B-cell lymphoma. Ann Hematol. 2011 Sep; 90(9):1075-82. Epub 2011 Feb 19.
Top
Policy History:
Date Reason Action
January 2011 Annual review Policy revised
January 2012 Annual review Policy renewed
Top
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
|
 |
