The Value of Pre-FDA Approval Healthcare Economic Information Exchange Between Payers and Drug Manufacturers

Overview

Journal Am Health Drug Benefits

Date 2017 Dec 22

PMID 29263775

Citations 4

Authors

Peter R Fendt

Brian Ung

F Randy Vogenberg

Affiliations

Soon will be listed here.

Citing Articles

Health care decision-maker perceptions and trends in the utilization of preapproval information for formulary decision-making.

Brisibe T, Hikmat Z, Hydery T, Gorey C, Boswell K J Manag Care Spec Pharm. 2024; 30(5):475-479.

PMID: 38701027 PMC: 11068649. DOI: 10.18553/jmcp.2024.30.5.475.

Best practices in designing preapproval information engagements for US health care decision makers.

Dodda S, Bannister B, Hydery T, Gorey C, Dunlap S, Mody L J Manag Care Spec Pharm. 2023; 29(3):245-250.

PMID: 36840953 PMC: 10387941. DOI: 10.18553/jmcp.2023.29.3.245.

The Inclusion of Economic Endpoints as Outcomes in Clinical Trials Reported to ClinicalTrials.gov.

Mitchell J, Patterson J J Manag Care Spec Pharm. 2020; 26(4):386-393.

PMID: 32223593 PMC: 10391117. DOI: 10.18553/jmcp.2020.26.4.386.

Communicating Healthcare Economic and Pre-approval Information With Healthcare Decision-Makers: Opportunities Following the 21st Century Cures Act and FDA Guidance.

Niyazov A, Lenci D Front Public Health. 2018; 6:304.

PMID: 30488029 PMC: 6246692. DOI: 10.3389/fpubh.2018.00304.

References

Neumann P, Claxton K, Weinstein M . The FDA's regulation of health economic information. Health Aff (Millwood). 2000; 19(5):129-37. DOI: 10.1377/hlthaff.19.5.129. View

Perfetto E, Burke L, Oehrlein E, Gaballah M . FDAMA Section 114: Why the Renewed Interest?. J Manag Care Spec Pharm. 2015; 21(5):368-74. PMC: 10398075. DOI: 10.18553/jmcp.2015.21.5.368. View

. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval. J Manag Care Spec Pharm. 2016; 23(1):105-112. PMC: 10398277. DOI: 10.18553/jmcp.2016.16366. View