The Challenges and Opportunities of Using Large Administrative Claims Databases for Biosimilar Monitoring and Research in the United States

Purpose of Review The number of marketed biosimilars in the USA is increasing and will require careful post-marketing monitoring. We address some of the challenges and opportunities of using administrative claims data both inside and outside the context of distributed research networks to monitor post-marketing biosimilar use, effectiveness, and safety in the USA. Recent Findings Three major challenges and opportunities of using administrative claims to monitor biosimilars in the post-marketing environment are presented. These include (1) having sufficient longitudinal follow-up of patients in the target population, (2) identifying biosimilar exposures at the specificity of interest, and (3) having sufficient and complete detailed information on study outcomes and potential confounders. Summary As true for all safety surveillance and comparative effectiveness studies, biologic and biosimilar research requires a focused inquiry to determine whether administrative claims or distributed research networks are suitable data sources. Administrative data affords longitudinal follow-up on large numbers of patients and includes dispensed medications and refill information, affording exposure data based on adjudicated payment. However, data elements including biosimilar exposures, outcomes, and confounders may not be measured at the desired level of specificity. Opportunities to link multiple sources of data together and augment existing data sources to include additional information may increase the utility of using administrative claims data in the monitoring of biosimilars..

Medienart:

E-Artikel

Erscheinungsjahr:

2018

Erschienen:

2018

Enthalten in:

Zur Gesamtaufnahme - volume:5

Enthalten in:

Current epidemiology reports - 5(2018), 1 vom: 26. Jan., Seite 10-17

Sprache:

Englisch

Beteiligte Personen:

Panozzo, Catherine A. [VerfasserIn]
Haynes, Kevin [VerfasserIn]

Links:

Volltext [lizenzpflichtig]

Themen:

Administrative claims
Biologics
Biosimilars
Distributed research networks
Pharmacoepidemiology

Anmerkungen:

© Springer International Publishing AG, part of Springer Nature 2018

doi:

10.1007/s40471-018-0133-4

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

OLC209512913X

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