Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

Background: The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety.

Choice architecture is a better strategy than engaging patients to spur behavior change.

Patient engagement is increasingly seen as a potentially effective way to improve quality and lower costs in health care. We review and synthesize current research, including our work with patients' use of prescription medications, to explore whether and in what settings patient engagement may not be realistic or even necessary. Our commentary argues that a more tempered assessment of patient engagement is warranted for the following three reasons: Evidence of the effectiveness of interventions to increase patient engagement on health outcomes is not definitive; ongoing and sustained patient engagement conflicts with cognitive limitations that are the hallmark of basic human nature; and, in some settings, choice architecture and associated strategies provide a clear alternative for improving behavior and decisions without relying on ongoing engagement.