S119performance-based risk-sharing arrangements (PBRSA). Our objective was to evaluate the endpoints used in PBRSAs and their alignment with FDA approved drug labels. MethodS: The study was a retrospective database analysis of the University of Washington's Performance Based Risk Sharing (PBRS) database. Only performancelinked reimbursement arrangements of pharmaceuticals in the United States between October 1997 to October 2017 were considered for our analysis. Endpoints used to evaluate health outcomes in PBRSAs were assessed for consistency with endpoints in their respective FDA approved label. They were labeled as "covered" if they appeared in both the PBRSA and the FDA approved label, or "non-covered" if they appeared in the PBRSA but are not included on the label. Adherence was excluded as an endpoint if it was not used as an outcome measure of safety or efficacy. ReSultS: We identified 473 PBRSAs in the PBRS database with 31 arrangements fitting the inclusion criteria. 77% (n= 24) of arrangements had only covered endpoints in their agreements, while 23% (n= 7) had at least one non-covered endpoint. These arrangements used non-covered endpoints like efficacy algorithms (n= 1), associated healthcare costs (n= 3), adherence (n= 2), and hospitalizations rates (n= 1) to evaluate outcomes. ConCluSionS: Historically, PBRSAs have been conservative by using outcome measures comprising of endpoints covered in their FDA approved label. Notable exceptions using more sophisticated endpoints suggest changes enacted by the 21st Century Cures Act may increase the viability and complexity of future PBRSAs. The study was limited to only publicly available arrangements, and does not address private arrangements or other issues surrounding implementation of PBRSAs.

18581 Background: Practice guidelines for empiric therapy of FN were created and implemented at our institution in January 2003, prior to which empiric therapy often included the use of cefp. These guidelines recommend the combination of pip/tazo with gentamicin or levofloxacin for most patients. This retrospective chart review compared the efficacy of pip/tazo combination therapy versus historical controls treated with cefp. Methods: 183 patients met eligibility criteria. 87 patients were treated with pip/tazo, with 92% receiving levofloxacin as the second agent. 75 patients received cefp, 16 of which initially also received either a fluoroquinolone or an aminoglycoside. Endpoints included a difference in the addition of vancomycin and antifungals, incidence of breakthrough infections, trends in antibiotic resistance, and survival until discharge. Groups were compared using chi-square or Student’s t-test as appropriate. Results: The two groups were not significantly different in any measured demographic or clinical characteristic. No statistical difference was found between groups for the addition of vancomycin (cefp 43%, pip/tazo 41%; p = 0.9898) or antifungals (cefp 45%, pip/tazo 51%; p = 0.1346). The incidence of breakthrough infections was comparable (cefp 25%, pip/tazo 26%; p = 0.7461), and microorganism eradication rates were not different between groups (cefp 48%, pip/tazo 54%; p = 0.41). However, of those who developed a breakthrough infection, survival was lower in the cefp group (37% vs. 63%; p = 0.0389). Additionally, the rate of overall survival to discharge was significantly lower in patients initially treated with cefp (83% vs. 94%; p = 0.0193). The antibiograms of the hematology floors were compared for the 2 years prior to and after implementation of our FN guidelines; no change in susceptibilities was observed. Conclusions: From these results, we conclude that pip/tazo combination therapy is a reasonable alternative to cefp for empiric treatment of FN. [Table: see text]

62% pursued AS. Use of AS varied across VAMCs (range:31%-84%). AS increased with age, and decreased with higher GS and NCCN risk group. Characteristics were similar among the 97 Veterans prospectively enrolled, including NCCN risk (VL: 24%, L: 38%, INT: 38%). A wide range of GPS results were observed (4-48).The GPS provided a refined risk group in 5% of VL, 27% of L, and 9% of INT. ConClusions: Both groups of patients had characteristics representative of low risk PCa in the VA. Chart review confirmed variation in use of AS. Analysis of 97 tested Veterans showed refined risk estimates after GPS. Results presented at the meeting will demonstrate the ability of the GPS assay to identify men with low risk PCa for AS or immediate therapy using individualized biological information.

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