Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Overview of In-Hospital, Off-Label vs. On-Label rFVIIa Use From the Premier Database (2000–2008)
The 2000–2008 data from the Perspective Comparative Database of Premier, Inc. (Charlotte, NC) was used to assess the in-hospital usage trends of rFVIIa (Figure). The Premier database includes information on 40 million annual hospitalizations occurring in 615 U.S. hospitals. The majority of rFVIIa use occurs in the outpatient setting, and the majority of outpatient use is for on-label indications related to hemophilia. According to the Premier database on in-hospital use in the U.S., cases of use for the approved hemophilia indications remained stable over time, whereas cases of off-label, in-hospital use increased. Off-label, in-hospital rFVIIa use was estimated to be 125 cases in 2000, underwent a moderate increase until 2005 when use became more frequent and was estimated to be 11,057 cases, and by 2008 was estimated to be 17,813 cases (97% of all of the estimated 18,311 in-hospital cases). The three most common off-label uses from 2000–2008 were for: adult cardiac surgery (16.4%), bleeding secondary to body trauma (15.9%), and intracranial hemorrhage (10.5%).
- Yank V, Tuohy CV, Logan AC, et al. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, Comparative Effectiveness Review 21 (Prepared by Stanford–UCSF Evidence-based Practice Center under Contract No. 290-02-0017). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC030-EF.
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