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The Centers for Medicare & Medicaid Services (CMS) and the National Cancer Institute (NCI) announced today they are working together to improve the process for bringing new, life-saving anti-cancer drugs to patients.

CMS Administrator Mark B. McClellan, M.D., Ph.D., and NCI Director Andrew C. von Eschenback, M.D., said collaborations being developed also will seek to increase the body of information that clinicians and patients use to guide decisions about how new technologies can be used more effectively to improve the lives of cancer patients.

"With so many new therapeutic options available to patients and doctors, and with patients becoming more active in their medical care, it's important that we make sure that they have relevant and reliable information to support the choices they're making," McClellan said. "Setting proper priorities for clinical research -- and finding more ways to support the critical clinical research studies -- is an important priority for us. We need to work together to serve society's long-term need for new knowledge, new technologies, and, above all, for effective healthcare that is affordable for all," McClellan said.

CMS and NCI, both components of the Department of Health and Human Services, are developing a joint Memorandum of Understanding that will address how the two agencies can work together in five areas of technology, science, and patient care:

1. A joint process for identifying high-priority clinical questions about the optimal use of new cancer technologies and the creation of a process for conducting post-approval studies to address these priority questions;
2. Defining a systematic process for consultations between CMS and NCI experts in the evaluation of new diagnostic and therapeutic cancer technologies for the purposes of payment and coverage decisions;
3. Developing more efficient methods of collecting clinical evidence on new cancer technologies and strategies for making this information more widely available to patients, clinicians, and researchers. The two agencies will also explore the inclusion of CMS claims data on the NCI bioinformatics grid, CA-BIG, to make this information more easily availability for research on outcomes, on comparative utilization of existing treatments, and other similar evaluations;
4. Developing a joint process for the prospective identification and evaluation of emerging technologies such as molecular imaging so that reimbursement policies will fully anticipate promising new cancer technologies and help expedite their adoption in the marketplace; and
5. The two agencies will identify opportunities for sharing data and resources aimed at improving the quality of care for cancer patients and addressing additional concerns such as cancer health disparity issues, reducing unwarranted variation in treatment patterns, and improving palliative and end of life care.

"In taking these important concrete steps, we are moving the NCI-CMS partnership from an idea to a working reality that will make a difference for patients," von Eschenbach said. "Our goal is to reduce the burden of cancer for all Americans through the improved development and delivery of safe, more effective therapies."

Major changes in the understanding of the biology of cancer are leading to a major shift in diagnostic and therapeutic approaches. CMS and NCI intend to work together to ensure that the reimbursement framework can adapt to these potentially critical changes. The CMS-NCI collaboration will better align the two agencies in order to make possible earlier access to safe and effective promising new technologies for the treatment of cancer.

CMS and NCI also have agreed to work together to develop collaborative efforts to identify and initiate high-priority clinical trials in areas where clinicians and patients have said that they need more and better clinical information to guide their decision making about new or competing treatment regimens.

As a first step in their collaboration, the two agencies will work together to develop a strategic approach for prioritizing these clinical questions and adopting joint processes that will allow for better clinical data collection after new treatments are approved by the Food and Drug Administration. Building on the successful work between NCI and FDA, this new collaboration between NCI and CMS will better align the efforts of all three agencies.

The NCI and CMS will also work together to coordinate standards and develop tools to streamline their interactions and accelerate the overall development of evidence for new cancer drugs. These activities will become part of the NCI's cancer Biomedical Informatics Grid, in which CMS has agreed to participate.

CMS will engage appropriate clinical experts from NCI in all stages of national coverage determination development, reach out to experts identified by NCI, and as appropriate, convene expert workshops and other opportunities for public comment to address complex or crosscutting questions.