BIO Submits Comments Re: ASCO Value Framework

The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback on the American Society of Clinical Oncology’s (ASCO’s) Value Framework released on June 22, 2015.

BIO represents biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO represents an industry that is devoted to discovering, and ensuring patient access to, innovative treatments. Accordingly, we closely monitor payment policies for their potential impact on medical innovation and patient access to drugs and biologicals, and appreciate the opportunity to review a draft of the Value Framework. BIO is very much aligned with ASCO’s goal of making clinically meaningful progress against cancer through research and the delivery of high-quality care to all patients with cancer. BIO also supports ASCO’s broader goal of creating tools “to assist the physician and patient in shared decision making with regard to cancer treatment.” We agree that patients and providers should have access to all of the relevant information when choosing a treatment regimen. However, we are concerned that the structure of the Value Framework as drafted will not achieve this goal.

Specifically, we are deeply concerned that the Value Framework does not meaningfully and systematically account for patient preferences and the need to construct individualized treatment plans. In fact, the Value Framework appears to focus on population-based, rather than personalized, decision-making. We also are concerned that the proposed cost measures do not provide sufficiently comprehensive information with regard to the costs and savings of a specific treatment regimen to patients and are not relevant in the context of individual patient/provider decision-making. Additionally, while ASCO does identify the limitations of the Value Framework—as they pertain to the net health benefit (NHB) and cost measures—BIO remains concerned that there is a significant potential for other stakeholders to use this information out of context, and to the direct detriment of patient access to needed therapies.