Getting the Right Evidence After Drug Approval

Rick A Vreman; Hubert G M Leufkens; Aaron S Kesselheim

doi:10.3389/fphar.2020.569535

Getting the Right Evidence After Drug Approval

Front Pharmacol. 2020 Sep 9:11:569535. doi: 10.3389/fphar.2020.569535. eCollection 2020.

Authors

Rick A Vreman^{1

2}, Hubert G M Leufkens¹, Aaron S Kesselheim³

Affiliations

¹ Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.
² National Health Care Institute (ZIN), Diemen, Netherlands.
³ Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, MA, United States.

Abstract

To generate comparative evidence in a timely fashion for drugs without restricting or delaying access, value-based pricing and reimbursement could be conditioned on a prospective, post-approval evidence generation plan.

Keywords: comparative evidence; evidence; health technology assessment; pricing; regulation; reimbursement; value-based.