Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Sep 9:11:569535.
doi: 10.3389/fphar.2020.569535. eCollection 2020.

Getting the Right Evidence After Drug Approval

Rick A Vreman  1   2 , Hubert G M Leufkens  1 , Aaron S Kesselheim  3
Affiliations

Getting the Right Evidence After Drug Approval

Rick A Vreman et al. Front Pharmacol. .

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.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Augustovski F., McClellan M. B. (2019). Current Policy and Practice for Value-Based Pricing. Value Health 22 (6), S4–S6. 10.1016/j.jval.2019.04.1918 - DOI - PubMed
    1. Bloem L. T., Mantel-Teeuwisse A. K., Leufkens H. G. M., De Bruin M. L., Klungel O. H., Hoekman J. (2019). Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union: A Retrospective Cohort Study. Clin. Pharmacol. Ther. 105 (2), 426–435. 10.1002/cpt.1169 - DOI - PubMed
    1. Chen E. Y., Raghunathan V., Prasad V. (2019). An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate. JAMA Intern. Med. 179 (7), 915–921. 10.1001/jamainternmed.2019.0583 - DOI - PMC - PubMed
    1. Cipriani A., Ioannidis J. P. A., Rothwell P. M., Glasziou P., Li T., Hernandez A. F., et al. (2020). Generating comparative evidence on new drugs and devices after approval. Lancet 395 (10228), 998–1010. 10.1016/S0140-6736(19)33177-0 - DOI - PubMed
    1. Eichler H.-G., Barker R., Bedlington N., Bouvy J. C., Broekmans A. W., Bucsics A., et al. (2018). The evolution of adaptiveness: balancing speed and evidence. Nat. Rev. Drug Discovery 17 (12), 845–846. 10.1038/nrd.2018.90 - DOI - PubMed

LinkOut - more resources