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Collaboration with CMS Breaking New Ground in Cancer Clinical Trials
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
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