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National Coverage Analysis (NCA) Tracking Sheet for Anticancer Chemotherapy for Colorectal Cancer (CAG-00179N)

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.

Incident to a physician's professional Service
Requestor Name(s)CMS internally generated request
Formal Request Accepted and Review Initiated02/12/2003
Expected NCA Completion Date01/31/2005
Public Comment Period05/02/2003 - 06/02/2003
Proposed Decision Memo Released11/01/2004
Proposed Decision Memo Public Comment Period: 11/01/2004 - 12/31/2004 
Decision Memo Released01/28/2005
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • Michael Lyman, RN, MPH
Lead Medical Officer(s)
  • James Rollins, MD

February 12, 2003

CMS begins national coverage determination review.

May 2, 2003

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.

June 3, 2003

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.

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August 18, 2003

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.

November 17, 2003

To accommodate a request to meet with industry representatives to further discuss emerging data on off-label uses of oxaliplatin and irinotecan, we will extend the due date for review of the NCD request to December 31, 2003

December 31, 2003

CMS is extending the due date to January 31, 2004, to allow time for internal review and clearance.

January 29, 2004

CMS continues to review the off-label uses of oxaliplatin and irinotecan. 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. The listed due date is for database purposes only.

February 12, 2004

The FDA approves cetuximab (Erbitux™), used either in combination with irinotecan or alone in patients who can not tolerate irinotecan, for the treatment of patients with colorectal cancer that has spread to other parts of the body, i.e., metastatic colorectal cancer.

February 26, 2004

The FDA approves bevacizumab (Avastin™), used in combination with intravenous 5-fluorouracil-based chemotherapy, as a first-line treatment for patients with metastatic colorectal cancer.

September 1, 2004

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.

November 1, 2004

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.

November 19, 2004

Because of the comlexity of questions for which we are requesting public comment, we are extending the due date for receipt of public comments 30 days to 12/31/04. The due date for publication of the final decision is 1/31/05.

December 31, 2004

Public comment period ended.

January 28, 2005

Final Decision Memorandum  has been posted to the CMS website.
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