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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 10/20/2005 Title: Radioimmunotherapy
Revision Date: Document: BI126:00
CPT Code(s): J3490, J3590, J9999
Public Statement

Radioimmunotherapy is designed to deliver radiation directly to tumor cells. This can be done by using monoclonal antibodies that are linked to radio-isotopes.

 

Two of these are: Zevalin (Ibritumomab tiuxetan) and Bexxar (Tositumomab). These are infusions designed for the treatment of certain forms of Non-Hodgkins Lymphoma. They are approved by the FDA for single courses of therapy.

 

These therapies require pre-payment review.


Medical Statement
  1. Ibritumomab tiuxetan (Zevalin)

Zevalin (radioimmunotherapy with ibritumomab tiuxetan) is considered medically necessary for the treatment of relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin`s lymphoma (NHL), when the patient meets the following criteria:

    1. Marrow involvement is less than 26 percent; and
    2. Platelet count is 100,000 cells/mm3 or greater; and
    3. Neutrophil count is 1,500 cells/mm3 or greater.

 

  1. Tositumomab (Bexxar)

Bexxar ( radioimmunotherapy with tositumomab ) is considered medically necessary for treatment of CD20 positive, follicular, non-Hodgkin`s lymphoma, with and without transformation, which is refractory to rituximab and has relapsed following chemotherapy, when the patient meets the following criteria:

    1. Marrow involvement is less than 26 percent; and
    2. Platelet count is 100,000 cells/mm3 or greater; and
    3. Neutrophil count is 1,500 cells/mm3 or greater.

Limits
  • The Zevalin therapeutic regimen is considered experimental and investigational for the initial treatment of persons with non-Hodgkin`s lymphoma.
  • A single course of treatment with Zevalin therapeutic regimen is considered medically necessary for members who meet the medical criteria.
  • The U.S. Food and Drug Administration (FDA) has stated that the safety of multiple courses of the Zevalin therapeutic regimen, or combination of this regimen with other forms of irradiation, has not been evaluated.

 

  • The Bexxar therapeutic regimen is considered experimental and investigational for the initial treatment of persons with NHL.
  • A single course of treatment with Bexxar therapeutic regimen is considered medically necessary for members who meet the medical criteria
  • The FDA has stated that the safety of multiple courses of the Bexxar therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.

Background

Ibritumomab tiuxetan consists of a monoclonal antibody linked to the radioactive isotope yttrium-90. After infusion into a patient, 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 cells.

Ibritumomab tiuxetan must be used along with rituximab (Rituxan), another monoclonal antibody that targets malignant B-lymphocytes and has been approved for treatment of low-grade B-cell NHL. Ibritumomab tiuxetan is approved by the U.S. Food and Drug Administration (FDA) for patients who have not responded to standard chemotherapy treatments or to the use of rituximab alone.

The Zevalin therapeutic regimen is administered in two parts. Patients first receive rituximab followed by a form of Zevalin with a low dose of radioactive chemical Indium-111 for screening purposes. If patients` tumors are properly targeted with this procedure, they receive rituximab again with a form of Zevalin that has a different radioactive chemical, Yttrium-90, that can provide a treatment benefit.

Bexxar consists of a monoclonal antibody, tositumomab, linked to the radioactive isotope iodine iodine-131. The monoclonal antibody targets the CD20 antigen, which is found on the surface of mature B cells and B cell tumors.

The Bexxar therapeutic regimen is administered in two steps: the dosimetric and therapeutic steps. Each step consists of a sequential infusion of tositumomab followed by iodine-131 (I 131) tositumomab. The therapeutic step is administered 7 -14 days after the dosimetric step.

The purpose of the dosimetric step is to provide a consistent radiation dose by adjusting for the individual patient`s rate of clearance of the drug. Clinical studies found that patients with high tumor burden, splenomegaly, or bone marrow involvement have a faster clearance, shorter terminal half-life, and larger volume of distribution. Patient-specific dosing, based on total body clearance, has been found to provide a consistent radiation dose, despite variable pharmacokinetics, by allowing each patient`s administered activity to be adjusted for individual patient variables.


Reference
  1. U.S. Food and Drug Administration, Office of Public Affairs. FDA approves first radiopharmaceutical product to treat non-Hodgkin`s lymphoma. T02-11. FDA Talk Paper. Rockville, MD: FDA; February 19, 2002. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01138.html .
  2. IDEC Pharmaceuticals. Zevalin (ibritumomab tiuxetan) prescribing information. San Diego, CA: IDEC; January 2002. Available at: http://www.zevalin.com/pdfs/zevalin_pi.pdf. Accessed March 5, 2003.
  3. No authors listed. Ibritumomab tiuxetan (Zevalin) for non-Hodgkin`s lymphoma. Med Lett Drugs Ther. 2002;44(1144):101-102.
  4. Gibson AD. Updated results of a phase III trial comparing Ibritumomab tiuxetan with rituximab in previously treated patients with non-Hodgkin`s lymphoma. Clin Lymphoma. 2002;3(2):87-89.
  5. Wiseman GA, Gordon LI, Multani PS, et al. Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia: A phase II multicenter trial. Blood. 2002;99(12):4336-4342.
  6. Witzig TE, Gordon LI, Cabanillas F, et al. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin`s lymphoma. J Clin Oncol. 2002;20(10):2453-2463.
  7. Wiseman GA, White CA, Sparks RB, et al. Biodistribution and dosimetry results from a phase III prospectively randomized controlled trial of Zevalin radioimmunotherapy for low-grade, follicular, or transformed B-cell non-Hodgkin`s lymphoma. Crit Rev Oncol Hematol. 2001;39(1-2):181-194.
  8. Wiseman GA, White CA, Stabin M, et al. Phase I/II 90Y-Zevalin (yttrium-90 ibritumomab tiuxetan, IDEC-Y2B8) radioimmunotherapy dosimetry results in relapsed or refractory non-Hodgkin`s lymphoma. Eur J Nucl Med. 2000;27(7):766-777.
  9. Witzig TE, White CA, Wiseman GA, et al. Phase I/II trial of IDEC-Y2B8 radioimmunotherapy for treatment of relapsed or refractory CD20(+) B-cell non-Hodgkin`s lymphoma. J Clin Oncol. 1999;17(12):3793-3803.
  10. Witzig TE, Flinn IW, Gordon LI, et al. Treatment with ibritumomab tiuxetan radioimmunotherapy in patients with rituximab-refractory follicular non-Hodgkin`s lymphoma. J Clin Oncol. 2002;20(15):3262-3269.
  11. Wiseman GA, Leigh BR, Erwin WD, et al. Radiation dosimetry results from a phase II trial of ibritumomab tiuxetan (Zevalin trade mark) radioimmunotherapy for patients with non-Hodgkin`s lymphoma and mild thrombocytopenia. Cancer Biother Radiopharm. 2003;18(2):165-178.
  12. Witzig TE, White CA, Gordon LI, et al. Safety of yttrium-90 ibritumomab tiuxetan radioimmunotherapy for relapsed low-grade, follicular, or transformed non-Hodgkin`s lymphoma. J Clin Oncol. 2003;21(7):1263-1270.
  13. Wiseman GA, Kornmehl E, Leigh B, et al. Radiation dosimetry results and safety correlations from 90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory non-Hodgkin`s lymphoma: Combined data from 4 clinical trials. J Nucl Med. 2003;44(3):465-474.
  14. Sgouros G, Squeri S, Ballangrud AM, et al. Patient-specific, 3-dimensional dosimetry in non-Hodgkin`s lymphoma patients treated with 131I-anti-B1 antibody: Assessment of tumor dose-response. J Nucl Med. 2003;44(2):260-268.
  15. Kaminski MS, Zelenetz AD, Press OW, et al. Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin`s lymphomas. J Clin Oncol. 2001;19(19):3918-3128.
  16. Kaminski MS, Estes J, Zasadny KR, et al. Radioimmunotherapy with iodine (131)I tositumomab for relapsed or refractory B-cell non-Hodgkin lymphoma: Updated results and long-term follow-up of the University of Michigan experience. Blood. 2000;96(4):1259-1266.
  17. Vose JM, Wahl RL, Saleh M, et al. Multicenter phase II study of iodine-131 tositumomab for chemotherapy-relapsed/refractory low-grade and transformed low-grade B-cell non-Hodgkin`s lymphomas. J Clin Oncol. 2000;18(6):1316-1323.
  18. Gopal AK, Gooley TA, Maloney DG, et al. High-dose radioimmunotherapy versus conventional high-dose therapy and autologous hematopoietic stem cell transplantation for relapsed follicular non-Hodgkin`s lymphoma: A multivariable cohort analysis. Blood. 2003;102(7):2351-2357.
  19. Cheson BD. Radioimmunotherapy of non-Hodgkin lymphomas. Blood. 2003;101(2):391-298.
  20. Corxia Corporation and GlaxoSmithKline. Bexxar (tositumomab and iodine I-131 tositumomab) product labeling. P/N: 400009-1. Rockville, MD: U.S. Food and Drug Administration; June 2003. Available at: http://www.fda.gov/cder/foi/appletter/2003/tosicor062703L.htm .
  21. National Horizon Scanning Centre (NHSC). 131-iodine tositumomab for non-Hodgkin`s lymphoma. Birmingham, UK: NHSC; 2002.
  22. National Horizon Scanning Centre (NHSC). Ibritumomab tiuxetan for NHL. Birmingham, UK: National Horizon Scanning Centre (NHSC); 2002.
  23. Pandit-Taskar N, Hamlin PA, Reyes S, et al. New Strategies in radioimmunotherapy for lymphoma. Curr Oncol Rep. 2003;5(5):364-371.
  24. Press OW, Unger JM, Braziel RM, et al. A phase 2 trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin lymphoma: Southwest Oncology Group Protocol S9911. Blood. 2003;102(5):1606-1612.
  25. Zelenetz AD. A clinical and scientific overview of tositumomab and iodine I 13 tositumomab. Semin Oncol. 2003;30(2 Suppl 4):22-30.
  26. Vose JM. Bexxar: Novel radioimmunotherapy for the treatment of low-grade and transformed low-grade non-Hodgkin`s lymphoma. Oncologist. 2004;9(2):160-172.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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