Dr. Enrique Seoane-Vazquez has published a new study in JAMA Internal Medicine that examined why some new drugs approved in the US have not been approved or recommended for reimbursement in other countries, and how costly these drugs are, alongside Dr. Catherine Pham, former Chapman University School of Pharmacy/Kaiser Permanente Pharmaceutical Economics and Policy Fellow, and coauthors at Kaiser Permanente.

The study found that out of 206 new US drug approvals from 2017 through 2020, 47 drugs were refused marketing authorization or not recommended for reimbursement in other countries due to unfavorable benefit-to-risk profiles, uncertain clinical benefits, or unacceptably high prices. The median US cost for these drugs was $115,281 per patient per year.

Drug expenditures in the US are higher than in any other country and are projected to continue increasing, so US health payers may benefit from evaluating international regulatory and reimbursement decision-making of new drugs. The study’s findings have important implications for US healthcare professionals and health systems, especially for drugs with limited international market presence. The US can benefit from a close examination of these drugs and highlights the need for the US to review regulatory decisions and health technology assessments of new drugs in other countries to improve access to safe and effective treatments of demonstrated value.

The work of Dr. Seoane-Vazquez and the researchers at Kaiser Permanente is to be celebrated for their dedication and commitment to advancing the field of medicine. Their work is a testament to the importance of research and the impact it can have on improving healthcare for people around the world. The study, “Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020,” is published online in JAMA Internal Medicine. https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2801020

Dr. Seoane-Vazquez, Ph.D., is a professor in pharmaceutical economics, regulation, and policy at Chapman University School of Pharmacy and Economic Science Institute, and coauthored with Catherine Pham, PharmD, MPH, Kim Le, PharmD, and Maisha Draves, MD, MPH, from Kaiser Permanente.