Aaron S Kesselheim
Biographic Data
| ID | 5537887 |
|---|---|
| NAME | Aaron S Kesselheim |
| GIVEN NAMES | Aaron S |
| FAMILY NAME | Kesselheim |
| SIGNATURE | KESSELHEIM A S |
| AFFILIATIONS | Brigham and Women's Hospital |
| ORCID | 0000-0002-8867-2666 |
| VERIFIED | Yes |
| TOTAL WORKS | 35 |
| TOTAL CITATIONS | 1 |
| AUTHOR COUNT | 35 |
| EDITOR COUNT | 0 |
| FIRST PUBLICATION YEAR | 2013 |
| LATEST PUBLICATION YEAR | 2026 |
| H-INDEX | 1 |
Deeming Doesn't Deliver
Changes in Medication Use During Medicaid Continuous Enrollment and Unwinding
This cross-sectional study found that changes in Medicaid medication use during the COVID-19 pandemic continuous enrollment period and after unwinding were smaller than corresponding changes in enrollment. Unwinding had measurable impacts on patient access to prescription medications, but states that implemented protective policies were able to mitigate these changes
Law, Politics, and Expert Panels at the US Food and Drug Administration
This Viewpoint discusses the lawfulness and credibility of the US Food and Drug Administration’s recent move to using expert panels rather than advisory committees for decision-making
Health Professional Students’ Knowledge About FDA Drug and Medical Device Regulation
Pharmaceutical access in Brazil
BACKGROUND: Brazil faces challenges in ensuring equitable access to prescription drugs for its population. Socioeconomic disparities contribute to health inequalities, impacting access to health care services, including medicines. Brazil's Unified Health System aims to provide universal health care coverage, but only 30·5% of people obtain all of their prescribed medications through public channels free of charge. The objective is to characterize…
Revenue Differences Between Top-Selling Small-Molecule Drugs and Biologics in Medicare
This study compares the revenues earned by manufacturers 9 vs 13 years following US Food and Drug Administration approval for negotiation-eligible products from 2012 to 2022
Health Care Spending After Initiating Sacubitril-Valsartan vs Renin-Angiotensin System Blockers for Heart Failure Treatment
This cohort study found that Medicare beneficiaries initiating sacubitril-valsartan to treat HFrEF had similar total health care spending as those initiating ACE-I/ARBs; higher prescription drug spending was offset by lower inpatient and outpatient spending. However, sacubitril-valsartan use was associated with higher patient out-of-pocket costs, which may exacerbate health disparities and limit access and affordability
Physician Perspectives on Pharmaceutical Promotion
This survey study reports the responses of medical students and residents about their interactions with and attitudes toward the pharmaceutical industry and changes over 13 years, from 2011 to 2024
Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs
The results of this study suggest that there was greater use of DAAs after states relaxed coverage restrictions related to liver disease severity, sobriety, or prescriber specialty. Further reductions or elimination of these rules may improve access to a highly effective public health intervention for patients with HCV
Use, Spending, and Prices of Adalimumab Following Biosimilar Competition
This cross-sectional study examines the use, spending, and prices of adalimumab biosimilars in the first year of market competition in the US
Patient Out-of-Pocket Costs for Biologic Drugs After Biosimilar Competition
Findings of this cohort study suggest that biosimilar competition was not consistently associated with lower OOP costs for commercially insured outpatients, highlighting the need for targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability for patients who need biologics
Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines
The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccin…
Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D
This cross-sectional study examines the characteristics of prior authorization policies for new drugs in Medicare Part D to understand whether they are consistent with US Food and Drug Administration indications
Outcomes of the 340B Drug Pricing Program
In this scoping review of the 340B program, we found that the 340B program was associated with financial benefits for hospitals, clinics, and pharmacies; improved access to health care services for patients; and substantial costs to manufacturers. Increased transparency regarding the use of 340B program revenue and strengthened rulemaking and enforcement authority for the Health Resources and Services Administration would support compliance and h…
Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration
Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021
In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA actions and advisory committee votes was most frequently an approval after a negative vote. This study demonstrated that these committees have played a key role in the FDA's decision-making process but that the FDA sought independent expert advice le…
Simulated Medicare Drug Price Negotiation Under the Inflation Reduction Act of 2022
In this cross-sectional study, simulating the drug price negotiation provisions in the Inflation Reduction Act of 2022 revealed important limitations, including strict selection criteria and the potential for drugs to become ineligible for negotiation during the 2 years between selection and prices taking effect. Despite these limitations, the policy still delivered substantial savings because ceiling prices offered steep discounts, in part, by e…
Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019
In this cross-sectional study of 18 top-selling brand-name drugs, excluding 1 anomaly, Medicaid average net prices declined from 2015 to 2019. Simultaneously, for non-Medicaid payers, net price increased more than previously published marketwide growth rates, raising the importance of restraining drug price growth in non-Medicaid markets. Rigorous and transparent methods to estimate Medicaid discounts are imperative to understand patterns in Medi…
Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
Importance The number of drugs approved through the accelerated approval or conditional marketing authorization pathways has increased with unclear evidence of their therapeutic value. Objectives To assess the therapeutic value of drug indications granted accelerated approval in the US or conditional marketing authorization in the European Union (EU) overall and for cancer indications. Design, Setting, and Participants This cohort study used the …
What Should US Policymakers Learn From International Drug Pricing Transparency Strategies
This article analyzes differences in prescription drug pricing transparency practices among 3 Organisation for Economic Co-operation and Development member nations: the United Kingdom, Germany, and Canada. Specifically, this article compares these countries' policies on list and net price disclosures and on how international reference pricing is used to evaluate merits and drawbacks of different pricing transparency approaches. Finally, the artic…
A Global Intellectual Property Waiver is Still Needed to Address the Inequities of Covid-19 and Future Pandemic Preparedness
In October 2020, India and South Africa submitted a proposal to the World Trade Organization (WTO) to suspend IP on all COVID-19 vaccines, therapeutics, and diagnostics until widespread vaccination could help achieve immunity among people in low- and middle-income countries. After 18 months, the final WTO Decision substantially watered down the original text proposed by India and South Africa, limiting it only to patents on vaccines and the use o…
Government Patent Use to Promote Public Health in the United States
Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities Rebecca E. WolitzJD, PhD, Aaron S. KesselheimMD, JD, MPH, and Jonathan J. DarrowSJD, LLM, JD, MBA Affiliation Rebecca E. Wolitz is with the Moritz College of Law, The Ohio State University, Columbus. Jonathan J. Darrow and Aaron S. Kesselheim are with the Program on Regulation, Therapeutics, and Law, Department of Medicine, Brigham and Women’s …
Medicare Spending on Drugs With Accelerated Approval, 2015-2019
This article examines the budgetary implications of high-priced accelerated approval drugs by estimating Medicare spending on these drugs from 2015 through 2019
Estimating Rebates and Other Discounts Received by Medicare Part D
Models that fail to properly account for increasing rebates and other discounts will overestimate Medicare Part D expenditures. Rigorous and transparent methods for estimating discounts are critical for understanding patterns in spending and developing new cost-containment strategies
How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices
The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device risks. As debate continues over whether the pathway needs to be altered, features of ethical use of 510(k)-cleared devices can include (1) heightened caution with respect to newly cleared 510(k) product…
Drug Shortages and the Defense Production Act
Drug Shortages and the Defense Production Act Brooke L. Raunig JD, RN, Aaron S. Kesselheim MD, JD, MPH, and Jonathan J. Darrow SJD, JD, MBA Affiliation The authors are with the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.CopyRightCorrespondence should be sent to Brooke L. Raunig, Research Fellow, De…
The Role of Direct-to-Consumer Pharmaceutical Advertising in Patient Consumerism
In 2012, pharmaceutical and medical device manufacturers spent more than $4 billion in the U.S. to promote their products to patients These direct-to-consumer advertisements (DTCA) are disseminated via television and radio, magazines and newspapers, and-increasingly-the Internet. DTCA has important implications for the consumerism movement in health care. High-tech media like smartphones and the growth in wireless Internet connectivity are allowi…
Prescription Drug Insurance Coverage and Patient Health Outcomes
Previous reviews have shown that changes in prescription drug insurance benefits can affect medication use and adherence. We conducted a systematic review of the literature to identify studies addressing the association between prescription drug coverage and health outcomes. Studies were included if they collected empirical data on expansions or restrictions of prescription drug coverage and if they reported clinical outcomes. We found 23 studies…
Protecting Pharmaceutical Patents and Test Data
The Trans-Pacific Partnership (TPP) Agreement is a proposed free trade agreement between the US and 11 other countries in Asia and South America covering many consumer goods, including prescription medicines. This review describes how the TPP could affect international laws governing intellectual property rights for prescription drugs, focusing on patents and exclusivity protections for test data, including their effect on reimbursement decisions…
Reprioritizing Research Activity for the Post‐Antibiotic Era
Many hold that the so‐called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this cris…
The Real‐World Ethics of Adaptive‐Design Clinical Trials
From the earliest application of modern randomized controlled trials in medical research, scientists and observers have deliberated the ethics of randomly allocating study participants to trial control arms. Adaptive RCT designs have been promoted as ethically advantageous over conventional RCTs because they reduce the allocation of subjects to what appear to be inferior treatments. Critical assessment of this claim is important, as adaptive desi…
Eliminating Coverage Discrimination Through the Essential Health Benefit's Anti-Discrimination Provisions
Transparency in Health and Health Care in the United States
Pain Management and Opioid Regulation
The still-growing US opioid epidemic lies at the intersection of two major public health challenges: reducing suffering from pain and containing the rising toll of harms associated with the use of opioids medications. Responding successfully to these challenges requires a substantial investment in surveillance and research on many fronts and a coordinated policy response by federal and state agencies and stakeholder organizations. A 2017 report o…
Drug Shortages and the Defense Production Act
Drug Shortages and the Defense Production Act Brooke L. Raunig JD, RN, Aaron S. Kesselheim MD, JD, MPH, and Jonathan J. Darrow SJD, JD, MBA Affiliation The authors are with the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.CopyRightCorrespondence should be sent to Brooke L. Raunig, Research Fellow, De…
Medicare Spending on Drugs With Accelerated Approval, 2015-2019
This article examines the budgetary implications of high-priced accelerated approval drugs by estimating Medicare spending on these drugs from 2015 through 2019
Estimating Rebates and Other Discounts Received by Medicare Part D
Models that fail to properly account for increasing rebates and other discounts will overestimate Medicare Part D expenditures. Rigorous and transparent methods for estimating discounts are critical for understanding patterns in spending and developing new cost-containment strategies
How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices
The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device risks. As debate continues over whether the pathway needs to be altered, features of ethical use of 510(k)-cleared devices can include (1) heightened caution with respect to newly cleared 510(k) product…
Associations Between Copays, Coverage Limits for Opioid Use Disorder Medications, and Prescribing in Medicaid, 2018
BACKGROUND: Opioid use disorder (OUD) affects millions of Americans, but only a fraction receive treatment. Many patients with OUD are enrolled in Medicaid, but elements of different state Medicaid programs' drug benefit designs may impact patients' access to life-saving care. OBJECTIVE: To describe medication for OUD (mOUD) use in Medicaid and examine the relationship between mOUD use and state drug benefit design plans. DESIGN/SUBJECTS: Cross-s…
Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
Importance The number of drugs approved through the accelerated approval or conditional marketing authorization pathways has increased with unclear evidence of their therapeutic value. Objectives To assess the therapeutic value of drug indications granted accelerated approval in the US or conditional marketing authorization in the European Union (EU) overall and for cancer indications. Design, Setting, and Participants This cohort study used the …
What Should US Policymakers Learn From International Drug Pricing Transparency Strategies
This article analyzes differences in prescription drug pricing transparency practices among 3 Organisation for Economic Co-operation and Development member nations: the United Kingdom, Germany, and Canada. Specifically, this article compares these countries' policies on list and net price disclosures and on how international reference pricing is used to evaluate merits and drawbacks of different pricing transparency approaches. Finally, the artic…
A Global Intellectual Property Waiver is Still Needed to Address the Inequities of Covid-19 and Future Pandemic Preparedness
In October 2020, India and South Africa submitted a proposal to the World Trade Organization (WTO) to suspend IP on all COVID-19 vaccines, therapeutics, and diagnostics until widespread vaccination could help achieve immunity among people in low- and middle-income countries. After 18 months, the final WTO Decision substantially watered down the original text proposed by India and South Africa, limiting it only to patents on vaccines and the use o…
Government Patent Use to Promote Public Health in the United States
Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities Rebecca E. WolitzJD, PhD, Aaron S. KesselheimMD, JD, MPH, and Jonathan J. DarrowSJD, LLM, JD, MBA Affiliation Rebecca E. Wolitz is with the Moritz College of Law, The Ohio State University, Columbus. Jonathan J. Darrow and Aaron S. Kesselheim are with the Program on Regulation, Therapeutics, and Law, Department of Medicine, Brigham and Women’s …
Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines
The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccin…
Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D
This cross-sectional study examines the characteristics of prior authorization policies for new drugs in Medicare Part D to understand whether they are consistent with US Food and Drug Administration indications
Outcomes of the 340B Drug Pricing Program
In this scoping review of the 340B program, we found that the 340B program was associated with financial benefits for hospitals, clinics, and pharmacies; improved access to health care services for patients; and substantial costs to manufacturers. Increased transparency regarding the use of 340B program revenue and strengthened rulemaking and enforcement authority for the Health Resources and Services Administration would support compliance and h…
Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021
This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration
Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021
In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA actions and advisory committee votes was most frequently an approval after a negative vote. This study demonstrated that these committees have played a key role in the FDA's decision-making process but that the FDA sought independent expert advice le…
Simulated Medicare Drug Price Negotiation Under the Inflation Reduction Act of 2022
In this cross-sectional study, simulating the drug price negotiation provisions in the Inflation Reduction Act of 2022 revealed important limitations, including strict selection criteria and the potential for drugs to become ineligible for negotiation during the 2 years between selection and prices taking effect. Despite these limitations, the policy still delivered substantial savings because ceiling prices offered steep discounts, in part, by e…
Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019
In this cross-sectional study of 18 top-selling brand-name drugs, excluding 1 anomaly, Medicaid average net prices declined from 2015 to 2019. Simultaneously, for non-Medicaid payers, net price increased more than previously published marketwide growth rates, raising the importance of restraining drug price growth in non-Medicaid markets. Rigorous and transparent methods to estimate Medicaid discounts are imperative to understand patterns in Medi…
Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs
The results of this study suggest that there was greater use of DAAs after states relaxed coverage restrictions related to liver disease severity, sobriety, or prescriber specialty. Further reductions or elimination of these rules may improve access to a highly effective public health intervention for patients with HCV
Medicine (26 works) · Pharmaceutical Economics and Policy (22 works) · Health Systems, Economic Evaluations, Quality of Life (18 works) · Political science (14 works) · Business (13 works) · Pharmacology (13 works) · Health care (12 works) · Law (12 works) · Pharmaceutical industry and healthcare (12 works) · Medical prescription (10 works)