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Paul F. Engstrom, Mara G. Bloom, George Daniel Demetri, Phillip G. Febbo, William Goeckeler, Marc Ladanyi, Bryan Loy, Kate Murphy, Michael Nerenberg, Paul Papagni, Mark Robson, Robert W. Sweetman, Sean Tunis, Jessica DeMartino and Jonathan K. Larsen

diagnostics: where we are, where we need to be . Biotechnol Healthc 2010 ; 7 : 22 – 25 . 18 Meckley LM Neumann PJ . Personalized medicine: factors influencing reimbursement . Health Policy 2010 ; 94 : 91 – 100 . 19 Blank PR Moch H

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Andrew D. Zelenetz, Islah Ahmed, Edward Louis Braud, James D. Cross, Nancy Davenport-Ennis, Barry D. Dickinson, Steven E. Goldberg, Scott Gottlieb, Philip E. Johnson, Gary H. Lyman, Richard Markus, Ursula A. Matulonis, Denise Reinke, Edward C. Li, Jessica DeMartino, Jonathan K. Larsen and James M. Hoffman

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.

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Bradford R. Hirsch and Gary H. Lyman

The introduction of alternative versions of biologic products, also known as biosimilars, into the United States market has been gaining increasing visibility as patents for many agents are nearing expiration. Unlike generics, which are regulated under the Hatch-Waxman legislation passed in 1984, the approval process for biosimilars in the United States has not been defined. In 2004, the European Union established a regulatory pathway for these agents, and the FDA is now following suit. The economic implications are large, with $66.9 billion spent on the top 20 biologics in 2009. Of the top 10 biologics, 6 are routinely used in oncology. As the regulatory requirements are debated, several critical issues must be resolved. The most obvious is that the agents must be shown to be comparable to the original biologic they intend to replace. Knowledge of pharmacokinetic parameters alone will not be adequate, but the amount of clinical data required by the FDA remains unclear. The regulations will define the ease with which a biosimilar can be brought to market, and the associated costs of trials will influence the ultimate price of the medications. Balancing the needs of the relevant stakeholders is critical to ensure patient safety while controlling costs, improving access, and encouraging innovation. This is not an easy balance to strike.

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Alyssa A. Schatz, Katy Winckworth Prejsnar, James McCanney, Meghan Gutierrez, Stefanie Joho, Joseph Alvarnas and Robert W. Carlson

-quality cancer care. To understand how shifting trends in health policy are impacting the oncology ecosystem, NCCN convened the NCCN Policy Summit: Policy Strategies for the “New Normal” in Healthcare to Ensure Access to High-Quality Cancer Care on June 25, 2018

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William T. McGivney

In the torrent of writings in health policy and in the sagacity of legislative discussions and health care reform, policy makers vie for inclusion, or even a vague recognition, of their personal view and plan for improving decision-making in the

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Nora Janjan

local disease control. Depending on the grade and uncontrolled pain of mucositis during chemoradiation, costs increased between $1700 and $6000 per patient. Reflecting changes in health policy, emphasis is increasingly being placed on patient

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Ndiya Ogba, Nicole M. Arwood, Nancy L. Bartlett, Mara Bloom, Patrick Brown, Christine Brown, Elizabeth Lihua Budde, Robert Carlson, Stephanie Farnia, Terry J. Fry, Morgan Garber, Rebecca A. Gardner, Lauren Gurschick, Patricia Kropf, Jeff J. Reitan, Craig Sauter, Bijal Shah, Elizabeth J. Shpall and Steven T. Rosen

Patients with relapsed or refractory (R/R) cancers have a poor prognosis and limited treatment options. The recent approval of 2 chimeric antigen receptor (CAR) autologous T-cell products for R/R B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma treatment is setting the stage for what is possible in other diseases. However, there are important factors that must be considered, including patient selection, toxicity management, and costs associated with CAR T-cell therapy. To begin to address these issues, NCCN organized a task force consisting of a multidisciplinary panel of experts in oncology, cancer center administration, and health policy, which met for the first time in March 2018. This report describes the current state of CAR T-cell therapy and future strategies that should be considered as the application of this novel immunotherapy expands and evolves.

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William T. McGivney

The entry of the United States health care system into the “era of accountability” was heralded by Arnold Relman, MD, then editor of The New England Journal of Medicine, in 1987. This new era of medicine was envisioned to involve a greater emphasis and reliance on evidence in setting policies and, most especially, a system whereby provider groups or even individual providers could be evaluated on the quality, effectiveness, and efficiency of the care that they delivered. Since that widely acclaimed heralding, health care constituencies have entered this “house of accountability,” but they have not made it much past the front foyer. Clearly, considerable resources and efforts have been invested in making decision-making in health care based more on evidence. Although all clinical researchers have long lived by the “evidence-based decision-making” credo, one of the two major accomplishments of managed care in the 1990s was enhanced integration of this basis for decision-making into processes for establishing clinical policies, health policies, and coverage policies. However, the brief era of managed care in the United States did not establish substantial capabilities to evaluate the quality or value of care delivered. Rather, the focus of the managed care environment in the 1990s was on micromanagement rather than on more global analyses and interventions. Managed care companies attempted to improve the value of the care that they managed for patients and employers, as purchasers, through focus on and scrutiny of individual care decisions, often at the point of delivery. Although such attempts at point-of-care...
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Melissa A. Simon, Laura S. Tom and XinQi Dong

Health expenditures have been an ongoing topic of debate in many health policy spheres. This issue of JNCCN includes an article, “Wealth, Health Expenditure, and Cancer: A National Perspective” (see page 972 ), that aims to provide a national

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Alicia K. Matthews, Patrick W. Corrigan and Judith Lee Rutherford

. Mental health policy project: Policy and service guidance package . Executive Summary. Department of Mental Health and Substance Abuse, Mental Health Policy and Service Department. Geneva, Switzerland , 2001 . 21 Eker D . Attitudes