Molecular testing and biosimilars offer the potential for increased access to targeted treatment options and reduction in healthcare costs, but come with significant challenges in ensuring patient access to innovation in cancer care while maintaining safe, effective, ethical, and affordable treatment options. As providers, payers, patients, and the larger healthcare systems become inundated with a wide variety of molecular diagnostics and an increased number of biosimilars coming to market, it will be important to understand regulatory guidance and policy implications relating to the appropriateness of molecular testing and the clinical use of biosimilars in cancer care. In September 2016, NCCN hosted the Molecular Testing and Biosimilars Policy Summit to address the challenges, issues, and opportunities in both the molecular testing and biosimilar landscapes. Keynote presentations and panelists further discussed the status and future of molecular testing and biosimilars within the oncology space, as well as patient access and education needs moving forward.
Katy Winckworth-Prejsnar, Elizabeth A. Nardi, Lisa Korin Lentz, Jeffrey A. Crawford, C. Lyn Fitzgerald and Robert W. Carlson
Katy Winckworth-Prejsnar, Lisa Korin Lentz, Elizabeth A. Nardi, Sandhya Pruthi, C. Lyn Fitzgerald and Robert W. Carlson
In order to empower patients as partners in their healthcare decisions, there is an identified need for value tools that provide enough information to help them make decisions regarding their cancer care journey. NCCN convened a multistakeholder working group to identify the gaps and needs of current value tools and develop a set of findings and recommendations for the evolution of value tools for patients. The findings and recommendations of the working group were then presented at the Value Tools for Patients in Cancer Care Patient Advocacy Summit in December 2016, and multistakeholder roundtable panel discussions explored these findings and recommendations along with additional items. This article encapsulates the discussion from the NCCN Working Group meetings and the NCCN Patient Advocacy Summit, including identified gaps and needs in defining value in cancer care, identified principles and parameters of value tools for patients in cancer care, and consensus statements and recommendations offered by the NCCN Working Group.
Katy Winckworth-Prejsnar, Elizabeth A. Nardi, James McCanney, F. Marc Stewart, Terry Langbaum, Bruce J. Gould, C. Lyn Fitzgerald and Robert W. Carlson
The inability to obtain the right high-quality cancer care in a timely and safe manner can have devastating results for patients. As cancer care becomes inundated with cutting edge and novel treatments, such as personalized medicine, oral chemotherapy, biosimilars, and immunotherapy, new safety challenges are emerging at increasing speed and complexity. Moreover, shifting federal healthcare policies could have significant implications for the safety and access to high-quality and effective cancer care for millions of patients with cancer. Challenges and opportunities in ensuring patient access to safe, affordable, and high-quality cancer care remain significant within the policy landscape. To address these concerns, NCCN hosted the Ensuring Safety and Access in Cancer Care Policy Summit in June 2017 to discuss pertinent patient safety issues and access implications under the Trump administration, as well as policy and advocacy strategies to address these gaps and build on opportunities moving forward.
Robert W. Carlson, Jonathan K. Larsen, Joan McClure, C. Lyn Fitzgerald, Alan P. Venook, Al B. Benson III and Benjamin O. Anderson
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) are evidence- and consensus-based clinical practice guidelines addressing malignancies that affect more than 97% of all patients with cancer in the United States. The NCCN Guidelines are used extensively in the United States and globally. Use of the guidelines outside the United States has driven the need to adapt the guidelines based on local, regional, or national resources. The NCCN Guidelines Panels created, vetted, and continually update the NCCN Guidelines based on published scientific data on cancer detection, diagnosis, and treatment efficacy. The guidelines are developed within the context of commonly available resources, methods of payment, societal and cultural expectations, and governmental regulations as they exist in the United States. Although many of the cancer management recommendations contained in the NCCN Guidelines apply broadly from a global perspective, not all do. Disparities in availability and access to health care exist among countries, within countries, and among different social groups in the same country, especially regarding resources for cancer prevention, early detection, and treatment. In addition, different drug approval and payment processes result in regional variation in availability of and access to cancer treatment, especially highly expensive agents and radiation therapy. Differences in cancer risk, predictive biomarker expression, and pharmacogenetics exist across ethnic and racial groups, and therefore across geographic locations. Cultural and societal expectations and requirements may also require modification of NCCN Guidelines for use outside the United States. This article describes the adaptation process, using the recent Latin American adaptation of the 2013 NCCN Guidelines for Colorectal Cancer as an example.
Katy Winckworth-Prejsnar, James McCanney, Alyssa A. Schatz, Warren Smedley, Leonidas C. Platanias, Cecil M. Benitez, Lee N. Newcomer, C. Lyn Fitzgerald and Robert W. Carlson
Multiple factors are forcing the healthcare delivery system to change. A movement toward value-based payment models is shifting these systems to team-based integration and coordination of care for better efficiencies and outcomes. Workforce shortages are stressing access and quality of care for patients with cancer and survivors, and their families and caregivers. Innovative therapies are expensive, forcing payers and employers to prioritize resources. Patients are advocating for care models centered on their needs rather than those of providers. In response, payment policies have recently focused on the promotion of alternative payment models that incentivize coordinated, high-quality care with consideration for value and controlling the increasing overall costs associated with cancer and its treatment. Given the multitude of factors confounding cancer care, NCCN convened a multistakeholder working group to examine the challenges and opportunities presented by changing paradigms in cancer care delivery. The group identified key challenges and developed policy recommendations to address 4 high-visibility topics in cancer care delivery. The findings and recommendations were then presented at the NCCN Policy Summit: Policy Challenges and Opportunities to Address Changing Paradigms in Cancer Care Delivery in September 2018, and multistakeholder roundtable panel discussions explored these findings and recommendations along with additional items. This article encapsulates the discussion from the NCCN Working Group meetings and the NCCN Policy Summit, including multistakeholder policy recommendations on delivery issues in cancer care designed to help inform national policies moving forward.
Elizabeth A. Nardi, Julie A. Wolfson, Steven T. Rosen, Robert B. Diasio, Stanton L. Gerson, Barbara A. Parker, Joseph C. Alvarnas, Harlan A. Levine, Yuman Fong, Dennis D. Weisenburger, C. Lyn Fitzgerald, Maggie Egan, Sharon Stranford, Robert W. Carlson and Edward J. Benz Jr
Key challenges facing the oncology community today include access to appropriate, high quality, patient-centered cancer care; defining and delivering high-value care; and rising costs. The National Comprehensive Cancer Network convened a Work Group composed of NCCN Member Institution cancer center directors and their delegates to examine the challenges of access, high costs, and defining and demonstrating value at the academic cancer centers. The group identified key challenges and possible solutions to addressing these issues. The findings and recommendations of the Work Group were then presented at the Value, Access, and Cost of Cancer Care Policy Summit in September 2015 and multi-stakeholder roundtable panel discussions explored these findings and recommendations along with additional items.