CMS to Re-open Public Comment Period Regarding Off-label Use(s) of Ibritumomab Tiuxetan and Tositumomab for Non-Hodgkin's Lymphoma

August 8, 2003

CMS to Re-open Public Comment Period Regarding Off-label Use(s) of Ibritumomab Tiuxetan and Tositumomab for Non-Hodgkin's Lymphoma

The comment period regarding off-label use(s) of Ibritumomab Tiuxetan and Tositumomab for Non-Hodgkin's Lymphoma will re-open for 30 days. CMS is modifying the title of the NCD to reflect its expanded scope. The due date for review of the NCD request is extended to November 4, 2003.

"Ibritumomab Tiuxetan is a radioimmunotherapy approved by the Food and Drug Administration, under the trade name Zevalin, to treat certain forms of non-Hodgkin's lymphoma. The therapeutic links monoclonal antibodies that bind to malignant and normal B cells with a radioisotope that provides localized radiation. The treatment regimen consists of Rituximab, a monoclonal antibody, preceding Indium-111 Ibritumomab Tiuxetan, to determine if the patient is a candidate for therapy, followed 7 to 9 days later by a second infusion of Rituximab prior to Yttrium-90 Ibritumomab Tiuxetan, the therapeutic arm. Given the uniqueness of this treatment which employs a diagnostic with a radioimmunotherapy, the Centers for Medicare and Medicaid Services (CMS) has internally generated a national coverage determination to assure that Ibritumomab Tiuxetan is appropriately used in the Medicare population. . . ."