One of NCI's important successes over the past several years has been the establishment of partnerships with other government agencies to help improve service to the public. The announcement earlier this month about expanded coverage by Medicare for several NCI-sponsored clinical trials is an excellent example of collaborations between sister health agencies to promote better cancer care.

Under the initiative, the Centers for Medicare and Medicaid Services (CMS) will pay for Medicare beneficiaries to receive off-label treatment with drugs already approved for specific indications in colorectal cancer: oxaliplatin (Eloxatin), irinotecan (Camptosar), bevacizumab (Avastin), and cetuximab (Erbitux). Coverage, however, is contingent upon the beneficiary's participation in designated NCI clinical trials.

This is new territory for CMS that expands on its traditional role as a third-party health care payer. By collaborating with NCI on this venture, CMS is supporting clinical trials that should provide more evidence upon which the agency can base future payment decisions. Indeed, the trials that will be included in this initiative will attempt to answer some important clinical questions that could have a significant impact on patient care.

Research has suggested that the drugs included in this effort may offer some improvement over, or be an alternative to, existing treatments for indications other than those for which they have received FDA approval. For example, in several early-stage trials, both cetuximab and bevacizumab have shown activity against pancreatic cancer - a malignancy for which there has been a dearth of new treatments - but neither drug is approved by the FDA for that indication. NCI has put forward, as a top priority to CMS, a clinical trial that will compare both of these drugs in treating pancreatic cancer. Other proposed trials include testing treatments for head and neck cancer, as well as several different treatment approaches for colorectal cancers at various stages and at various points in the treatment continuum (e.g., first-line, adjuvant). The trials for which CMS will provide expanded coverage will be finalized over the coming months.

Although none of these trials were designed in response to this initiative, CMS's involvement should help to speed patient accrual and improve patient retention by assuring Medicare participants that drug and related administration costs, as well as diagnostic and monitoring tests (e.g., scans, blood tests), will be covered by CMS when they are not specifically provided for free as part of the research. In return, CMS will receive valuable information to help guide the agency as it grapples with tough decisions on what new cancer treatments to cover at a time when the health care dollar garners far less than it used to.

As CMS Administrator Dr. Mark B. McClellan stated in announcing this new initiative, CMS is hoping to focus on ensuring the most prudent use of the increasingly stretched taxpayer dollar while also improving the quality of cancer care. NCI concurs with CMS that a collaboration based on providing sound medical evidence for the most effective therapies for appropriate patients is a worthy goal, and one with which this new partnership can advance more rapidly.

Dr. Andrew C. von Eschenbach
Director, National Cancer Institute