Oxaliplatin is an antineoplastic agent (a platinum analogue) approved by the Food and Drug Administration (FDA), under the trade name Eloxatin, for use in combination with 5-fluorouracil (5-FU) and leucovorin in patients with colorectal cancer whose disease has recurred or has become worse following initial therapy with a combination of irinotecan with 5-FU and leucovorin. It is not approved for patients with newly diagnosed colorectal cancer. Given the potential impact of this treatment on the Medicare program, the Centers for Medicare & Medicaid Services (CMS) has internally generated a national coverage determination to evaluate when oxaliplatin is reasonable and necessary in the Medicare population.
After internal review of clinical studies and analysis of public comments, we have decided to limit our national coverage determination review to consideration of off-label, adjuvant use of anti-cancer chemotherapy for patients with colorectal cancer. We will review both irinotecan (Camptosar) and oxaliplatin (Eloxatin).
We invite the public to submit evidence or comments regarding off-label, adjuvant drug therapy for colorectal cancer. We will extend the public comment period by 30 days, ending on 6/2/03. (This information should be submitted to Gay Burton at CMS, 7500 Security Blvd., Mailstop C1-09-06, Baltimore, MD 21244-1850.)
To accommodate this review, we will extend the due date for review of the NCD request to 7/2/03.
CMS accepts a formal request to extend the public comment period six weeks, ending on 7/14/03, to enable the preparation of a submission detailing information relating to irinotecan (Camptosar®) in the adjuvant therapy of colon cancer.
We invite the public to submit evidence or comments regarding off-label, adjuvant drug therapy for colorectal cancer during the extended comment period. (This information should be submitted to Gay Burton at CMS, 7500 Security Blvd., Mailstop C1-09-06, Baltimore, MD 21244-1850.)
To accommodate this review, we will extend the due date for review of the NCD request to 8/14/03.
CMS has held multiple meetings with industry representatives, has had extended discussions with the National Cancer Institute staff and has received substantive information on off-label uses of the drugs under review, including but not limited to first line therapy for oxaliplatin and adjuvant therapy for both drugs. To accommodate the analysis of this evidence, we will extend the due date for review of the NCD request to 11/17/2003.
We are also modifying the title of the NCD to reflect its current scope.
We are modifying our national coverage determination review to include consideration of off-label uses of oxaliplatin, irinotecan, bevacizumab, and cetuximab that are not listed as indicated in one or more of the major drug compendia cited in §1861(t)(2)(B)(ii)(I) of the statute.
We are modifying the title of the NCD tracking sheet to reflect the current scope.
We are meeting with the National Cancer Institute on September 15, 2004 to discuss clinical and scientific issues including identification of high-priority clinical questions and collection of evidence about the optimal use of these drugs.
We are posting our proposed decision memorandum. We invite comments on the decision memorandum, the trials recommended for coverage, the process for selecting future trials, and the process contractors use to approve off-labeled use of anticancer drugs.