RESUMO
BACKGROUND: The U.S. health care system's transition to a value-based reimbursement model holds important implications for medical innovation, care delivery, and value-based assessments of therapeutic interventions. This transition has been especially noteworthy in oncology, with substantial ongoing changes to payer reimbursement and the provider landscape, as well as the introduction of value frameworks to guide drug treatment decision making. The implications of these changes for provider assessments of drug value and evidence needs remain unclear. OBJECTIVES: To understand provider perspectives on drug value assessment and the utility of existing oncology value frameworks by identifying (a) key value-based trends in the evolving oncology landscape, (b) provider definitions of drug value, (c) the role of existing value frameworks in provider decision making, and (d) future provider evidence needs for making value-based treatment decisions. METHODS: We conducted a literature review to identify existing oncology value frameworks and definitions of drug treatment value in oncology. Using a structured discussion guide informed by this literature review, we conducted 12 telephone-based in-depth interviews in November and December 2017 with U.S. oncology providers involved in organizational drug treatment and formulary decision making within their practices. Responses to interview questions were analyzed and reported as averages and percentages across participants. RESULTS: Of 293 publications identified by keyword searches, 35 relevant articles were identified. Among these, the literature review identified no common definition for providers to assess drug value. Interview research participants described large ongoing changes in the oncology provider landscape, with economic pressures from payers as the foremost leading factor. Although 5 value frameworks were found in the literature, interviews found that in practice few providers consider these value frameworks to be key influences when evaluating treatment or formulary decisions. Furthermore, while 83% of participants' organizations employed some form of internal clinical pathways, only the minority (25%) with pathways integrated in their electronic medical record (EMR) systems saw these pathways as significantly affecting clinicians' drug treatment decision making. To aid the ongoing shift from volume-based to value-based care, we found that, rather than value frameworks, providers are looking for patient-level tools to make more appropriate drug decisions. CONCLUSIONS: Payer reimbursement pressures are leading to radical changes in the oncology provider landscape, and there is a need for improved guidance for providers in assessing drug value. In particular, this study identifies the need for a timely and multifaceted summary of information required to assess the value of alternative treatment options for a given patient. Manufacturers also need to make significant strides to help generate and improve the dissemination of evidence to support the value of their therapies. DISCLOSURES: Funding for this work was provided by Novartis Pharmaceuticals. The study sponsor was involved in study design, data interpretation, and data review. All authors contributed to the development of the manuscript and maintained control over the final content. Sasane, Howe, Wong, and Zacker were employees of Novartis at the time of this study. Frois, Jarvis, and Grice are or have been employed by Analysis Group, which received a grant from Novartis for this research. At the time of this study, Analysis Group received funding from multiple manufacturers with oncology products in their portfolio during this time period, including, but not limited to, Astellas and Genentech.