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JAMA Oncology
Original Investigation
April 4, 2024
Ariadna Tibau,Ѷ, PhD; Thomas J.Hwang,Ѷ; Consolacion Molto,Ѷ, PhD; Jerry Avorn,Ѷ; Aaron S.Kesselheim,Ѷ, JD, MPH
JAMA Oncol. 2024; 10(5):634-641. 10.1001/jamaoncol.2024.0194
This cohort study assesses the validity of molecular targets and therapeutic benefits of US Food and Drug Administration (FDA)–approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.
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JAMA Oncology
Viewpoint
September 7, 2023
Thomas J.Hwang,Ѷ; Benjamin J.Davies,Ѷ; Mark A.Preston,Ѷ, MPH
JAMA Oncol. 2023; 9(11):1491-1492. 10.1001/jamaoncol.2023.3304
This Viewpoint encourages investigators to move beyond FDA guidance toward patient-centered therapies and health equity for BCG-unresponsive bladder cancer.
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Ƶ Network Open
Research Letter
Health Policy
January 13, 2023
Neeraj G.Patel, BA; Thomas J.Hwang,Ѷ; Steven Woloshin,Ѷ, MS; Aaron S.Kesselheim,Ѷ, JD, MPH
open access
Ƶ Netw Open. 2023; 6(1):e2250991. 10.1001/jamanetworkopen.2022.50991
This cohort study assesses whether drugs with the most direct-to-consumer television advertising represent advances over existing treatments.
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JAMA Health Forum
Original Investigation
January 13, 2023
Lisa Clemans-Cope, PhD; Marni Epstein, BA; Jessica Banthin, PhD; Aaron S.Kesselheim,Ѷ, JD, MPH; Thomas J.Hwang,Ѷ
open access
JAMA Health Forum. 2023; 4(1):e225012. 10.1001/jamahealthforum.2022.5012
This cross-sectional study considers 18 top-selling drugs to demonstrate a new approach to improved estimation of Medicaid rebates to better understand trends in Medicaid and non-Medicaid spending and drug pricing.
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JAMA Pediatrics
Research Letter
November 7, 2022
Kavya Pathak, BA; Claire Narang, BS; Thomas J.Hwang,Ѷ; Juan C.Espinoza,Ѷ; Florence T.Bourgeois,Ѷ, MPH
open access
JAMA Pediatr. 2022; 177(1):98-100. 10.1001/jamapediatrics.2022.4131
This cohort study examines the characteristics of high-risk therapeutic devices approved by the US Food and Drug Administration for use in children and adolescents between 2016 and 2021.
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JAMA
Viewpoint
October 24, 2022
Thomas J.Hwang,Ѷ; Aaron S.Kesselheim,Ѷ, JD, MPH; Kerstin N.Vokinger,Ѷ, JD, PhD
JAMA. 2022; 328(18):1807-1808. 10.1001/jama.2022.19459
This Viewpoint proposes restructuring the WHO Essential Medicines List to remove consideration of cost and cost-effectiveness from the expert committee reviews of clinical effectiveness, safety, and public health value, and chartering a new framework for pooled global negotiation and procurement of costly medicines included in the list.
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JAMA
Viewpoint
August 19, 2022
Thomas J.Hwang,Ѷ; Aaron S.Kesselheim,Ѷ, JD, MPH; Benjamin N.Rome,Ѷ, MPH
JAMA. 2022; 328(11):1041-1042. 10.1001/jama.2022.15268
This Viewpoint describes the provisions and limitations of prescription drug pricing reforms enacted by US Congress as part of the Inflation Reduction Act in August 2022.
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JAMA Health Forum
Original Investigation
August 19, 2022
Kerstin N.Vokinger,Ѷ, JD, PhD, LLM; Aaron S.Kesselheim,Ѷ, JD, MPH; Camille E. G.Glaus, BSc, JD, LLM; Thomas J.Hwang,Ѷ
open access
JAMA Health Forum. 2022; 3(8):e222685. 10.1001/jamahealthforum.2022.2685
This cohort study assesses the therapeutic value of drugs granted accelerated approval or conditional marketing authorization in the US and European Union from 2007 to 2021.
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JAMA Oncology
Editorial
August 4, 2022
Thomas J.Hwang,Ѷ; Aaron S.Kesselheim,Ѷ, JD, MPH; Stacie B.Dusetzina, PhD
JAMA Oncol. 2022; 8(10):1398-1400. 10.1001/jamaoncol.2022.2828
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Ƶ Network Open
Research Letter
Health Policy
April 6, 2022
Kerstin N.Vokinger,Ѷ, JD, PhD, LLM; Thomas J.Hwang, AB; Camille E. G.Glaus, BSc, JD, LLM; Aaron S.Kesselheim,Ѷ, JD, MPH
open access
Ƶ Netw Open. 2022; 5(4):e226479. 10.1001/jamanetworkopen.2022.6479
This economic evaluation study assesses the clinical benefit of novel drugs approved in 2018 and 2019 and examines whether drugs approved with special regulatory designations appear to provide meaningful therapeutic value.
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JAMA Internal Medicine
Viewpoint
December 13, 2021
Thomas J.Hwang, AB; Kerstin N.Vokinger,Ѷ, PhD; Aaron S.Kesselheim,Ѷ
JAMA Intern Med. 2021; 182(2):101-102. 10.1001/jamainternmed.2021.7168
This Viewpoint describes the therapeutic ratings and coverage decisions taken by key bodies across the US, Canada, and Europe.
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JAMA Oncology
Research Letter
November 11, 2021
Thomas J.Hwang, AB; Xuanzi Qin, PhD, MSPH; Nancy L.Keating,Ѷ, MPH; Haiden A.Huskamp, PhD; Stacie B.Dusetzina, PhD
free access
JAMA Oncol. 2021; 8(1):155-156. 10.1001/jamaoncol.2021.5433
This cross-sectional study examines patients’ out-of-pocket costs with and without rebate pass-through to point-of-sale prices for cancer drugs under Medicare Part D.
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JAMA Oncology
Original Investigation
July 1, 2021
Kerstin N.Vokinger,Ѷ, JD, PhD, LLM; Thomas J.Hwang, AB; Paola Daniore, MSc; ChangWon C.Lee, AB; Ariadna Tibau,Ѷ; Thomas Grischott,Ѷ, MSc; Thomas J.Rosemann,Ѷ, PhD; Aaron S.Kesselheim,Ѷ, JD, MPH
free access
online only
JAMA Oncol. 2021; 7(9):e212026. 10.1001/jamaoncol.2021.2026
This economic evaluation examines the prices of cancer drugs on initial marketing and postlaunch prices and any association with clinical benefit.
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JAMA
Viewpoint
Health Policy
March 2, 2021
Aaron S.Kesselheim,Ѷ, JD, MPH; Thomas J.Hwang, AB; Jerry Avorn,Ѷ
JAMA. 2021; 325(9):819-820. 10.1001/jama.2021.0009
This Viewpoint discusses policies the Biden administration can enact to reduce costs, including benchmarking Medicare Part B drug payments to the lowest price paid in similar countries, preventing Part D plans from negotiating confidential rebates with manufacturers, and patent reform to promote generic drug use.
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JAMA Pediatrics
Viewpoint
May 7, 2020
Thomas J.Hwang, AB; Adrienne G.Randolph,Ѷ, MSc; Florence T.Bourgeois,Ѷ, MPH
free access
JAMA Pediatr. 2020; 174(9):825-826. 10.1001/jamapediatrics.2020.1888
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.
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JAMA
Viewpoint
November 22, 2019
Thomas J.Hwang, AB; Aaron S.Kesselheim,Ѷ, JD, MPH; Kerstin N.Vokinger,Ѷ, JD, PhD
JAMA. 2019; 322(23):2285-2286. 10.1001/jama.2019.16842
This Viewpoint discusses the appropriateness of existing US Food and Drug Administration regulatory pathways for artificial intelligence (AI) and machine learning (ML) software in health care, and proposes a lifecyle-based framework given the iterative nature of AI/ML algorithms, including prespecified “safe harbor” provisions for change and postapproval audits of accuracy.
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JAMA
Research Letter
July 16, 2019
Thomas J.Hwang, AB; Stacie B.Dusetzina, PhD; Josh Feng, PhD; Luca Maini, PhD; Aaron S.Kesselheim,Ѷ, JD, MPH
free access
JAMA. 2019; 322(3):267-269. 10.1001/jama.2019.7521
This study characterizes price increases exceeding inflation between 2012 and 2017 for protected-class drugs (antineoplastics, antiretrovirals, antidepressants, antipsychotics, anticonvulsants, and immunosuppressants for transplant patients) that would lead to their exclusion from Medicare Part D coverage based on excessive cost under a 2018 CMS rule intended to facilitate more effective price negotiations.
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JAMA Oncology
Viewpoint
February 21, 2019
Thomas J.Hwang, AB; Kerstin N.Vokinger,Ѷ, JD, PhD; Rachel E.Sachs, JD, MPH
JAMA Oncol. 2019; 5(4):461-462. 10.1001/jamaoncol.2018.7093
This Viewpoint evaluates new transparency policies in cancer research and drug development.
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JAMA Internal Medicine
Original Investigation
Health Care Reform
January 14, 2019
Thomas J.Hwang, AB; Nina Jain,Ѷ, MBA; Julie C.Lauffenburger, PharmD, PhD; Kerstin N.Vokinger,Ѷ, JD, PhD; Aaron S.Kesselheim,Ѷ, JD, MPH
free access
has multimedia
JAMA Intern Med. 2019; 179(3):374-380. 10.1001/jamainternmed.2018.6417
This analysis of 75 brand-name drugs uses Medicare data to estimate the costs of proposed Medicare Part B and Part D reforms on total drug spending and patient cost-sharing for prescription drugs.
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JAMA Pediatrics
Original Investigation
January 1, 2019
Thomas J.Hwang, AB; Liat Orenstein, MSc; Aaron S.Kesselheim,Ѷ, JD, MPH; Florence T.Bourgeois,Ѷ, MPH
free access
JAMA Pediatr. 2019; 173(1):68-74. 10.1001/jamapediatrics.2018.3416
This cohort study evaluates the characteristics, completion rate, and transparency of study design and results for mandatory pediatric postmarketing studies required under the Pediatric Research Equity Act.