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Lindsey A.M. Bandini, Leigh Gallo, Terrell Johnson, Kara Martin, Alyssa A. Schatz, Kerin Adelson, Bryan A. Loy, Ronald S. Walters, Tracy Wong and Robert W. Carlson

NCCN Oncology Policy Summit: Defining, Measuring, and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care brought together physicians, payers, policymakers, patient advocates, and technology partners to explore

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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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Terrell Johnson, Lindsey A.M. Bandini, Kara Martin, Lee Jones, Jennifer Carlson, Ronald S. Walters and Robert W. Carlson

The American health system has experienced substantial changes over the last decade. A new phenomenon is the growing authority of states over health policies historically administered by federal policymakers. This shift, partially introduced by the

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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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Terrell Johnson, Lindsey A.M. Bandini, Darryl Mitteldorf, Elizabeth Franklin, Justin E. Bekelman and Robert W. Carlson

As the oncology ecosystem shifts from service-based care to outcomes and value-based care, stakeholders cite concerns regarding the lack of patient experience data that are important to the patient community. To address the patient perspective and highlight the challenges and opportunities within policy and clinical decision-making to improve patient-centered care, NCCN hosted the NCCN Patient Advocacy Summit: Delivering Value for Patients Across the Oncology Ecosystem on December 11, 2019, in Washington, DC. The summit featured multidisciplinary panel discussions, keynote speakers, and patient advocate presentations exploring the implications for patient-centered care within a shifting health policy landscape. This article encapsulates and expounds upon the discussions and presentations from the summit.