Evidence to inform biopharmaceutical policy: call for research on the impact of public policies on investment in drug development.

This paper highlights the pressing need for updated, robust evidence to inform biopharmaceutical policy, particularly in light of recent initiatives such as the Inflation Reduction Act. Current estimates that inform such policies, including those from the Congressional Budget Office, rely on outdated data and models that fail to fully capture the complexities of modern investment decisions or the broader impact of policies on drug development in areas like oncology, rare diseases, and vaccines. Understanding how expectations of financial returns influence investment in all stages of drug development is critical for evaluating these policies' long-term effects on innovation.

Expected Out-Of-Pocket Costs: Comparing Medicare Advantage With Fee-For-Service Medicare.

We compared the generosity of Medicare plans in terms of out-of-pocket costs attributable to cost sharing and premiums, including both basic and supplemental services. From 2014 through 2019, projected out-of-pocket costs for a typical enrollee were 18-24 percent lower in Medicare Advantage than traditional fee-for-service Medicare.

Expanding Pharmaceutical Access Via Over the Counter Drugs.

This commentary addresses the recent U.S. Food & Drug Administration (FDA) proposed rule to expand access to nonprescription drugs through additional conditions of nonprescription use (ACNU).

Lessons for cannabinoid regulation from electronic nicotine delivery system product regulation.

Cannabis legalization continues to spread, with 38 states permitting the use of medical marijuana, 22 states permitting recreational use, and growing political momentum for federal legalization. The last time the Food and Drug Administration (FDA) was tasked with regulating a new product occurred with 2009's Family Smoking Prevention and Tobacco Control Act, which created the Center for Tobacco Products (CTP). Thus, the time is ripe to review the history of CTP with particular attention to difficulties the nascent center faced in regulating novel products such as e-cigarettes or electronic nicotine delivery systems (ENDS).

Expanding Medicare Coverage Of Anti-Obesity Medicines Could Increase Annual Spending By $3.1 Billion To $6.1 Billion.

The introduction of highly effective anti-obesity drugs, such as Wegovy, has prompted debate over Medicare's prohibition on coverage of such products. In this study, we estimated the costs of allowing Medicare coverage of anti-obesity medications. Our analysis incorporated data on drug costs, real-world adherence rates, and potential changes to other health care spending.

Using artificial intelligence to improve administrative process in Medicaid.

Administrative burden across state-federal benefits programs is unsustainable, and artificial intelligence (AI) and associated technologies have emerged and resulted in significant interest as possible solutions. While early in development, AI has significant potential to reduce administrative waste and increase efficiency, with many government agencies and state legislators eager to adopt the new technology. Turning to existing frameworks defining what functions are considered "inherently governmental" can help determine where more autonomous implementation could be not only appropriate but also provide unique advantages.

Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.

Applications of Artificial Intelligence in Health Care Delivery.

Health care costs now comprise nearly one-fifth of the United States' gross domestic product, with the last 25 years marked by rising administrative costs, a lack of labor productivity growth, and rising patient and physician dissatisfaction. Policy experts have responded with a series of reforms that have - ironically - increased patient and physician administrative burden with little meaningful effect on cost and quality. Artificial intelligence (AI), a topic of great consternation, can serve as the "wheat thresher" for health care delivery, empowering and freeing both patients and physicians by decreasing administrative burden and improving labor productivity.

Role of Patient Sorting in Avoidable Hospital Stays in Medicare Advantage vs Traditional Medicare.

Importance: Unlike traditional Medicare (TM), Medicare Advantage (MA) plans limit in-network care to a specific network of Medicare clinicians. MA plans thus play a role in sorting patients to a subset of clinicians. It is unknown whether the performance of physicians who treat MA and TM beneficiaries is different.

Socioeconomic vulnerability and differential impact of severe weather-induced power outages.

In response to concerns about increasingly intense Atlantic hurricanes, new federal climate and environmental justice policies aim to mitigate the unequal impact of environmental disasters on economically and socially vulnerable communities. Recent research emphasizes that standard procedures for restoring power following extreme weather could be one significant contributor to these divergent outcomes. Our paper evaluates the hypothesis that more economically and socially vulnerable communities experience longer-duration power outages following hurricanes than less vulnerable communities do, conditional on the severity of the impact of the storm itself.

An international comparative analysis and roadmap to sustainable biosimilar markets.

Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability. The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council.

The 510(k) Third Party Review Program: Promise and Potential.

Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating newer technology such as artificial intelligence (AI), machine learning (ML), and other software. As the complexity of these novel technologies and the number of applications is expected to increase in the coming years, statutory changes such as the 2016 21 Century Cures Act, regulations, and guidance documents have increased both the volume and complexity of device review.

The impact of the COVID-19 pandemic on global GDP growth.

This paper describes one of the first attempts to gauge the effect of the COVID-19 pandemic on the global trajectory of real GDP over the course of 2020 and 2021. It is also among the first efforts to distinguish between the role of domestic variables and global trade in transmitting the economic effects of COVID-19. We estimate panel data regressions of the quarterly growth in real GDP on pandemic variables for 90 countries over the period 2020 Q1 through 2021 Q4.

The influence of Medicare Part D on the list pricing of brand drugs.

Objective: To compare the Medicare Part D market share of brand drugs with their net-to-list price ratio.

Data Sources And Study Setting: SSR Health Brand Net Price Tool and Medical Expenditure Panel Survey, 2007-2019.

Study Design: For each drug, we calculated the ratio of net to list price and the percent of users that were Medicare-eligible.