In 2011 NCCN addressed two important policy areas in oncology – biosimilars and molecular testing – by forming Work Groups that identified areas of concern and developed recommendations where possible. NCCN held corresponding policy summits during which the areas of concern and recommendations were shared. At the end of September 2011, in anticipation of FDA guidance on biosimilars, JNCCN published the "NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives," which provided the NCCN Biosimilars Work Group's recommendations and comments about the challenges health care providers and other key stakeholders face in incorporating biosimilars into oncology practice in the United States. In December 2011, JNCCN published the "NCCN Molecular Testing White Paper: Effectiveness, Efficiency, and Reimbursement" which provided guidance regarding challenges of molecular testing in oncology to health care providers and other stakeholders.
On Tuesday, April 2, 2013, NCCN held the NCCN Oncology Policy Summit: Evolving Policy Issues in Oncology – Revisiting Biosimilars and Molecular Testing at the National Press Club in Washington, DC. Stakeholders gathered to examine how biosimilars and molecular testing in oncology have changed since they were addressed by NCCN Work Groups and at the NCCN Policy Summits in 2011. The Summit's agenda included discussion of the current status of these areas, review of the newest guidance documents and regulatory requirements, examination of payer viewpoints and practices, and discussion about where the oncology community is headed on these two important issues. The program, moderated by Clifford Goodman, PhD, of The Lewin Group, consisted of two short presentations and two roundtable discussions with vigorous discussion and audience participation.
The morning session, focused on biosimilars, commenced with an overview of the milestones of biosimilars development from James Hoffman, PharmD, MS, BCPS, St. Jude Children's Research Hospital. Dr. Hoffman reviewed key consensus statements, recommendations, and challenges identified by the NCCN Biosimilars Work Group in 2011 and highlighted areas of concern still surrounding biosimilars—safety, tracking, naming, substitution practices, and provider education.
This introductory presentation was followed by a roundtable discussion moderated by Dr. Goodman. The panelists included Jeff Allen, PhD, Friends of Cancer Research; Stan Bukofzer, MB, BCh, MMed, Hospira; Leah Christl, PhD, US Food and Drug Administration (FDA); Dr. Hoffman; Richard Markus, MD, PhD, Amgen; Lee Newcomer, MD, MHA, UnitedHealthcare; Marjorie Shapiro, PhD, FDA; and Andrew Zelenetz, MD, PhD, Memorial Sloan-Kettering Cancer Center. The discussion revolved around a variety of issues surrounding biosimilars development and their clinical use, including, but not limited to, interchangeability standards, formularies, and substitution practices.
The afternoon portion of the Summit was dedicated to molecular testing as Mark Kris, MD, Memorial Sloan-Kettering Cancer Center, explained how treatment has evolved due to the advent of molecular testing, using lung cancer as an example. Dr. Kris reviewed the general types of biomarkers and concluded with predictions of where the molecular testing field will be in 10 years. These predictions included, but were not limited to, more validated clinical targets with available therapies, as well as more comprehensive, cheaper, and faster multiplex testing for all targets at diagnosis.
Pam Germain, MBA, Roswell Park Cancer Institute; Ellie Guardino, MD, PhD, Genentech; Lawrence Jennings, MD, PhD, College of American Pathologists; Dr. Kris; Elizabeth Mansfield, PhD, FDA; Doug Moeller, MD, McKesson Health Solutions; and Dr. Newcomer, participated in a follow-up roundtable discussion. The group discussed the challenges for the broader integration of molecular testing into oncology practice, development of laboratory developed tests (LDTs), companion diagnostics, and coding and reimbursement of molecular testing.
A summary of the Summit is now available for those who could not attend.