William T. McGivney

NCCN: your best resource in the fight against cancer.

An oncologist came up to me not that many years ago and said, “We thank NCCN; NCCN is our last, best hope.” Those words still ring true. The policies and processes in the cancer care delivery system increasingly attempt to limit the autonomy and authority of oncologists and other clinicians to decide—in concert with patients and caregivers—what is best for patients. The strength of NCCN has been and shall be the ongoing commitment to integrating scientific evaluation of the results of clinical research with the vast experience, expertise, and clinical judgment of NCCN panel members and others to establish evidence-based/expert-based recommendations regarding appropriate therapeutic options. The NCCN Guidelines stand as testament to the dedication and commitment of those who, through the years, have painstakingly established the thousands of pages of recommendations. The NCCN Guidelines quickly became the standard of oncology care in the United States in the early 2000s. Soon thereafter, payers began using guideline recommendations as the basis for coverage policy. NCCN was fastidious and driven about timely updating and communicating recommendations about new technologies and important issues. NCCN also was exceedingly adept at applying formats to attract and facilitate the work of decision-makers (eg, physicians, practice managers, payers). As an example of this, the NCCN Drugs & Biologics Compendium (NCCN Compendium), a derivative of the NCCN Guidelines, became the basis for and the driver of coverage policy for drugs and biologics.

Access to and Appropriateness of Cancer Care: Who Decides?

William T. McGivney, PhD, is Chief Executive Officer of the NCCN, responsible for the development of strategies and programs to improve the quality of care available to cancer patients. Such programs include the NCCN Clinical Practice Guidelines in Oncology, NCCN Oncology Outcomes Database, NCCN Oncology Research Program, and NCCN Drugs & Biologics Compendium. Strategically, Dr. McGivney is responsible for the growth of NCCN’s influence in the oncology community and for assuring the development of partnerships with managed care companies and employers, the development of NCCN’s health information capabilities, and the expansion of centralized research programs. Before joining NCCN, Dr. McGivney was Director of the Division of Health Care Technology at the American Medical Association and then Vice President for Clinical and Coverage Policy at Aetna Health Plans. While at Aetna, he helped establish the first formal independent outside review process. Dr. McGivney, a recognized expert in coverage policy and in drug and device regulatory policy, was awarded the FDA Commissioner’s Medal of Appreciation in 1989. He has served on numerous national boards and committees including as President of the Board of the Patient Advocate Foundation and National Patient Advocate Foundation and as a member of the UNOS Board of Directors and the Medicare Coverage Advisory Committee. Access to and Appropriateness of Cancer Care: Who Decides?

Pathways: A Road to Restriction?

Not all pathways are created equal. Similar to and derived from the concept of guideline development and adherence, the development of specific pathways or protocols can and should be an evidence-based, evaluative process with the goal of more tightly defining appropriate care for the patient populations served by oncology practices or centers. Indeed, there are examples of well-defined, scientifically based sets of such pathways and, even more specifically, protocols that offer high-quality and effective care. Our free-wheeling society, however, also presents opportunities for permutations and perversions of appropriately methodical, scientifically based processes. Entrepreneurs and those with an entrepreneurial bent seek to satisfy and capitalize on market needs and niches. For practicing oncologists today, the introduction and provision of pathways to health insurance companies by for-profit vendors represents yet another layer. These pathways also represent another challenge to the care provider’s individual autonomy to make decisions based on evidence and expert judgment in the best interests of the patients sitting in front of them seeking help. The goal of some pathway programs seems to be to please the insurer with the promise, if not guarantee, that implementing a limited set of clinical pathways will significantly reduce the costs of treating patients with cancer. Proof of cost savings might be proffered by implementing pathways that lead to and may focus drug use on generic or generic-based regimens. Although such savings may be real in the specific circumstance reported, broader application to everyday management across multiple tumor types, and the subpopulations of patients within such tumor types, is extremely limited. Further, the gains offered by innovative biologics and drugs (while incremental in some indications) can be removed from consideration depending on the use specifications of the pathway program by insurers. The sale of one of these pathway companies for over

NCCN Guidelines and Their Impact on Coverage Policy

500 million in 2010 seems to have incited what could be seen as a metaphoric gold rush, stampede, or even uncontrollable metastasis. The presence of a for-profit incentive in no way eliminates the potential for attaining good, and in many instances the good can be achieved more quickly with this incentive. However, some observers of pathway companies are concerned about the seeming lack of openness and transparency of the processes for pathway development. They are concerned by what are perceived to be pathways dominated by the drive for cost reduction without due consideration of the evidence for and ability of “more expensive” innovative protocols to deliver significant benefit and to meet individual patient needs. They are concerned with limitations in the ability to update quickly. Finally, some see dichotomous situations in which a company might provide services to oncology practices on one hand and own a company that sells pathways and protocols—with attendant limitations on those same practices— on the other. My last commentary, in the March issue (JNCCN 2010;9:265–266), focused on the major issue confronting patient and provider communities—who decides on access to and appropriateness of cancer care. The Wennberg1,2 studies on practice variation and the announcement of the “Era of Accountability” by Relman3 in the late 1980s were clarion calls to clinicians to build, establish, and apply a foundation of scientific evidence integrated with expert judgment in a more formal and systematic way to decision-making on population, sub-population and, individual patient levels. Guideline, pathway, and protocol efforts are a necessary and key part of this formal process. The goal of most such efforts is to ultimately provide better care to patients so that they can live longer and better lives. Economic issues and considerations now William T. McGivney, PhD