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Importance: Biologics account for a substantial proportion of health care expenditures. Their costs have been projected to reach US $452 billion in global spending by 2022. Given recent expiration of patent protection of biologics, a shift toward greater follow-on competition among biosimilars would be expected that would allow greater uptake and lower drug costs., Objective: To assess uptake and prices of biosimilars in the US compared with 2 European countries (Germany and Switzerland) with national mechanisms for drug price negotiation., Design, Setting, and Participants: In this cohort study, biologics and biosimilars that were approved in the US, Germany, and Switzerland until August 2020 were identified. Prices and sales data were extracted from public and commercial databases for the years 2011 to 2020. Data were analyzed from August 1, 2021, to February 28, 2022., Main Outcomes and Measures: Descriptive statistics were used to show temporal trends in the uptake of biosimilars and relative prices compared with those of reference products (ie, biologic agents) for each country. Descriptive analysis was also performed to compare the uptake of biosimilars between the 3 countries limited to biologics that have biosimilars on the market in all countries. To test if biosimilar awareness in each country increased over the last decade, a linear least squares regression was applied., Results: The study cohort included 15 biosimilars and 6 biologics for the US, 52 biosimilars and 15 biologics for Germany, and 28 biosimilars and 13 biologics for Switzerland. Uptake of biosimilars increased over time in all countries. On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the US. Monthly treatment costs of biosimilars in the US were a median of 1.94 (IQR, 1.78-2.44) and 2.74 (IQR, 1.91-3.46) higher than corresponding costs in Germany and Switzerland, respectively., Conclusions and Relevance: The findings of this cohort study suggest that more biosimilars have been marketed in Germany and Switzerland than in the US. Policies that counter anticompetitive practices in the US could allow biosimilars to enter the market sooner and could also lower health care costs with improved access. Awareness of biosimilars should be promoted to increase uptake of biosimilars globally.

Background: Long-term prescriptions of strong opioids for chronic noncancer pain-which are not supported by scientific evidence-suggest miscalibrated risk perceptions among those who prescribe, dispense, and take opioids. Because risk perceptions and behaviors can differ depending on whether people learn about risks through description or experience, we investigated the effects of descriptive versus simulated-experience educative formats on physicians' risk perceptions of strong opioids and their prescription behavior for managing chronic noncancer pain., Methods: Three hundred general practitioners and 300 pain specialists in Germany-enrolled separately in two independent exploratory randomized controlled online trials-were randomly assigned to either a descriptive format (fact box) or a simulated-experience format (interactive simulation)., Primary Endpoints: Objective risk perception (numerical estimates of opioids' benefits and harms), actual prescriptions of seven therapy options for managing chronic pain., Secondary Endpoint: Implementation of intended prescriptions of seven therapy options for managing chronic pain., Results: Both formats improved the proportion of correct numerical estimates of strong opioids' benefits and harms immediately after intervention, with no notable differences between formats. Compared to description, simulated experience led to significantly lower reported actual prescription rates for strong and/or weak opioids, and was more effective at increasing prescription rates for non-drug-based therapies (e.g., means of opioid reduction) from baseline to follow-up for both general practitioners and pain specialists. Simulated experience also resulted in a higher implementation of intended behavior for some drug-based and non-drug-based therapies., Conclusions: The two formats, which recruit different cognitive processes, may serve different risk-communication goals: If the goal is to improve exact risk perception, descriptive and simulated-experience formats are likely to be equally suitable. If, however, the goal is to boost less risky prescription habits, simulated experience may be the better choice., Trial Registration: DRKS00020358 (German Clinical Trials Register, first registration: 07/01/2020)., (© 2022. The Author(s).)

Objectives: Opioid prescription rates worldwide suggest miscalibrated risk perceptions among those who prescribe, dispense, and take opioids. Findings from cognitive science show that risk perceptions can differ systematically depending on whether people learn about risks by description or experience. We investigated the effects of descriptive and simulated experience risk formats on patients' risk perceptions and behavior regarding long-term strong opioid use., Methods: 300 German patients with chronic noncancer pain were randomly assigned in an exploratory randomized controlled trial to either a descriptive format (fact box) or a simulated experience format (interactive simulation). Primary endpoints were subjective and objective risk perceptions and intended intake behavior., Results: Both formats significantly improved patients' objective risk perception; patients who saw the fact box estimated some outcomes more accurately (p = .031). Formats were equally effective in improving patients' subjective risk perception in terms of opioids' harms; however, patients receiving the simulation showed a greater reduction and termination of their opioid intake (p = .030) and a higher uptake of alternative therapies., Conclusions: Descriptive and simulated experience risk formats improve risk perceptions and behavior regarding potent but highly risky drugs., Practice Implications: To eliminate risky behavior, simulated experience formats may be superior to descriptive formats., (Copyright © 2021. Published by Elsevier B.V.)

Overtreatment at the End of Life in Oncology Abstract. The term overtreatment refers to situations, in which we evaluate the use of diagnostic or therapeutic measures negatively. On the one hand, these negative judgments refer to questionable scientific foundations of using respective measures. On the other hand, we challenge the adequacy of using medical measures in the context of overtreatment with reference to principle of beneficence. To determine the indication of medical measurements in a medically and ethically reflected way may serve as one starting point for avoiding overtreatment. Over the last two decades numerous studies, mainly in the United States of America and Europe, have shown that the use of anticancer treatments at the end of life has increased considerably. Moreover, the overuse of chemotherapy or targeted therapeutic agents as well as radiotherapy in terminally ill cancer patients in the last months of life was associated with an increased risk of undergoing cardiopulmonary resuscitation, mechanical ventilation or both and of dying in an intensive care unit. More recently, early provision of palliative care for patients with incurable cancer has gained increased attention as a feasible and efficacious approach for improving quality of life. Therefore, the doctor-patient communication is central for the avoidance of overtreatment. It should clarify not only the patient's wishes and priorities, but also his or her understanding of the approaching end of life. In spite of this, both is not the norm in everyday clinical practice; the reasons are to be found in a lack of training, structural obstacles, but also projections and assumptions on both sides. An early and structured approach, if necessary with the help of palliative medicine, can reduce these deficiencies.