The expanded use of biologic agents in cancer has contributed substantially to the continued rise in US healthcare costs. Recent statistics show biologics accounting for 62% of the $18.5 billion USD total Medicare Part B drug spending, exerting additional pressure for drug-savings measures.1 Some experts have proposed that biosimilars could mitigate this continued upslope through competing market prices relative to their reference product. This is especially relevant because many patents for biologics are expiring within the next 5 years, including those for 4 of the top 10 drugs by cost.2 Such bending of the cost curve would require robust acceptance of biosimilars by the prescribing oncologists and the patients they treat.
Biosimilars contain a highly similar version of the active substance of an already approved biologic agent, referred to as the “reference product.”3 Regulatory agencies such as the FDA allow at least 1 of the approved indications for the reference product to be listed as an indication for the biosimilar, but the FDA mandates that safety, efficacy, dosing, route of administration, and immunogenicity are established first.3 In addition, the FDA allows extrapolation of safety and efficacy data from one biosimilar indication to another after rigorous requirements are fulfilled.4 These requirements are meant to assure clinicians that extrapolation is safe and effective. Extrapolation is a cost-saving measure welcomed in a resource-constrained environment that recognizes limitations of conducting expensive confirmatory randomized studies for every indication in every disease stage.4
Behavioral economics is a discipline that combines insights from psychology, economics, judgment, and decision-making to better understand, predict, and potentially change human behavior. Tversky and Khaneman5 launched the field with a series of experiments that confirmed that people are often irrational economic actors. The authors proposed that such irrational behavior relied on a limited number of heuristic principles, which reduce the complex intellectual tasks of assessing probabilities and predicting values to simplified judgment operations. These heuristics, however, can lead to serious erroneous biases in decision-making that may have significant impact on healthcare reform.
SheingoldSNguyenNX. Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit. Medicare Medicaid Res Rev2014;4.
NabhanCFillmanJErnstFRFeinbergBA. Community oncologists' perception and understanding of biosimilars' role in oncology. Presented at the ISPOR 22nd Annual International Meeting; May20–242017; Boston, MA. Available at: https://www.ispor.org/ScientificPresentationsDatabase/Presentation/71071. Accessed November 27 2017.