Medicare Coverage Database |
Content Section
| Issue |
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.
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| Benefit Category |
| Diagnostic Tests (other), Incident to a physician's professional Service |
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| Requestor Name(s) |
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CMS internally generated request | | |
| Formal Request Accepted and Review Initiated |
| 7/26/2002 |
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| Expected NCA Completion Date |
| 7/25/2005 |
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| Proposed Decision Memo Released |
| 5/4/2005 |
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| Decision Memo Released |
| 7/25/2005 |
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| Lead Analyst(s) |
Francina Spencer
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| Lead Medical Officer(s) |
Lori Paserchia, MD
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| Actions Taken |
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| July 26, 2002 |
CMS begins national coverage determination review. |
| August 6, 2003 |
CMS has held multiple meetings internally and with industry and had extended discussions with FDA. As a result, we are narrowing the scope of this NCD to only consider off-label uses of Zevalin.
In addition, Tositumomab (Bexxar) had recently received FDA approval for limited indications in the treatment of non-Hodgkin's lymphoma. Bexxar constitutes another radioimmunotherapeutic regimen administered in discrete steps. Given the similar features of these two treatments employing diagnostic and radioimmuno-therapeutic phases, CMS will also add a review of the off-label uses of Bexxar to this NCD.
As a result of these actions, CMS will re-open the public comment period for 30 days. We invite the public to submit evidence or comments regarding off-label use(s) of Ibritumomab Tiuxetan and Tositumomab for non-Hodgkin's lymphoma. (The information should be submitted to Francina Spencer at CMS, 7500 Security Blvd., Mailstop C1-09-06; Baltimore, MD 21244-1850.)
We are also modifying the title of the NCD to reflect its expanded scope.
To accommodate this analysis, we will extend the due date for review of the NCD request to November 4, 2003 |
| November 17, 2003 |
To accommodate a request to meet with industry representatives to further discuss emerging data on off-label uses of ibritumomab and tositumomab, we will extend the due date for review of the NCD request to December 31, 2003 |
| January 29, 2004 |
CMS continues to review the off-label uses of Ibritumomab Tiuxetan and Tositumomab. Until CMS completes its review, coverage will continue to be determined by Medicare contractors in accordance with the Medicare statute.
We are establishing no new due date at this time. |
| January 28, 2005 |
CMS will shortly announce a proposed decision that will continue the current policies on use of Ibritumomab Tiuxetan and Tositumomab. |
| May 4, 2005 |
Proposed Decision is posted with a 30 day public comment period. |
| July 25, 2005 |
Final Decision Memorandum is posted. |
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