The Milbank quarterly
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The Milbank quarterly · Dec 2020
Comparative StudyApproval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Policy Points Regulatory agencies may have limited evidence on the clinical benefits and harms of new drugs when deciding whether new therapeutic agents are allowed to enter the market and under which conditions, including whether approval is granted under special regulatory pathways and obligations to address knowledge gaps through postmarketing studies are imposed. In a matched comparison of marketing applications for cancer drugs of uncertain therapeutic value reviewed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we found frequent discordance between the two agencies on regulatory outcomes and the use of special regulatory pathways. Both agencies often granted regular approval, even when the other agency judged there to be substantial uncertainty about drug benefits and risks that needed to be resolved through additional studies in the postmarketing period. Postmarketing studies imposed by regulators under special approval pathways to address remaining questions of efficacy and safety may not be suited to deliver timely, confirmatory evidence due to shortcomings in study design and delays, raising questions over the suitability of the FDA's Accelerated Approval and the EMA's Conditional Marketing Authorization as tools for allowing early market access for cancer drugs while maintaining rigorous regulatory standards.
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The Milbank quarterly · Dec 2020
The Role of Value-Based Payment in Promoting Innovation to Address Social Risks: A Cross-Sectional Study of Social Risk Screening by US Physicians.
Policy Points One of the most important possibilities of value-based payment is its potential to spur innovation in upstream prevention, such as attention to social needs that lead to poor health. Screening patients for social risks such as housing instability and food insecurity represents an early step physician practices can take to address social needs. At present, adoption of social risk screening by physician practices is linked with having high innovation capacity and focusing on low-income populations, but not exposure to value-based payment. Expanding social risk screening by physician practices may require standardization and technical assistance for practices that have less innovative capacity.
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The Milbank quarterly · Dec 2020
Dark Nudges and Sludge in Big Alcohol: Behavioral Economics, Cognitive Biases, and Alcohol Industry Corporate Social Responsibility.
Policy Points Nudges steer people toward certain options but also allow them to go their own way. "Dark nudges" aim to change consumer behavior against their best interests. "Sludge" uses cognitive biases to make behavior change more difficult. We have identified dark nudges and sludge in alcohol industry corporate social responsibility (CSR) materials. These undermine the information on alcohol harms that they disseminate, and may normalize or encourage alcohol consumption. Policymakers and practitioners should be aware of how dark nudges and sludge are used by the alcohol industry to promote misinformation about alcohol harms to the public.
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The Milbank quarterly · Dec 2020
Educational Inequalities in Hospital Use Among Older Adults in England, 2004-2015.
Policy Points US policymakers considering proposals to expand public health care (such as "Medicare for all") as a means of reducing inequalities in health care access and use could learn from the experiences of nations where well-funded universal health care systems are already in place. In England, which has a publicly funded universal health care system, the use of core inpatient services by adults 65 years and older is equal across groups defined by education level, after controlling for health status. However, variation among these groups in the use of outpatient and emergency department care developed between 2010 and 2015, a period of relative financial austerity. Based on England's experience, introducing universal health care in the United States seems likely to reduce, but not entirely eliminate, inequalities in health care use across different population groups.
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The Milbank quarterly · Dec 2020
A Commons for a Supply Chain in the Post-COVID-19 Era: The Case for a Reformed Strategic National Stockpile.
Policy Points Reflecting on current response deficiencies, we offer a model for a national contingency supply chain cell (NCSCC) construct to manage the medical materials supply chain in support of emergencies, such as COVID-19. We develop the following: a framework for governance and response to enable a globally independent supply chain; a flexible structure to accommodate the requirements of state and county health systems for receiving and distributing materials; and a national material "control tower" to improve transparency and real-time access to material status and location.