Incorporating comparative effectiveness research study endpoints into the treatment for positive-node, endocrine-responsive breast cancer (RxPONDER) study.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. TPS101-TPS101 ◽  
Author(s):  
S. D. Ramsey ◽  
W. E. Barlow ◽  
C. Moinpour ◽  
A. M. Gonzalez-Angulo ◽  
G. N. Hortobagyi ◽  
...  
2018 ◽  
Vol 7 (1) ◽  
pp. 57-66 ◽  
Author(s):  
Alexis A Krumme ◽  
Ajinkya Pawar ◽  
Sebastian Schneeweiss ◽  
Robert J Glynn ◽  
Niteesh K Choudhry ◽  
...  

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19273-e19273
Author(s):  
Jennifer Webster ◽  
Jeffrey A. Scott ◽  
Helen Smith ◽  
Danielle Wieland ◽  
Joseph Donaldson ◽  
...  

e19273 Background: In late 2019, the Center for Medicare and Medicaid Innovation (CMMI) issued a request for information (RFI) for the Oncology Care First (OCF) program, which will extend the evaluation of value-based care in the community oncology setting for an additional five years, through 2026. We have learned through the Oncology Care Model (OCM) that there are savings to be found by reducing inpatient admissions and emergency department visits and controlling for things such as duplicate labs. However, it has become increasingly clear that further savings will require practices to evaluate their use of both cancer-directed therapy and supportive therapy. To this end, Integra Connect has developed a tool, the Value Monitor, that allows for statistically rigorous comparative effectiveness research at scale, using real world data. As an initial proof of concept, we used the Value Based Care Monitor to compare the efficacy for febrile neutropenia prophylaxis between two pegfilgrastims: Udenyca, a biosimilar, and Neulasta, the originator. Methods: The Integra Connect Value Monitor was used to perform a matched cohort analysis of breast cancer patients receiving Udenyca vs patients receiving Neulasta from 1/1/2017 – 8/31/2019. Patients were matched on age (within 5 years), gender, OCM participation status and date of treatment (within 90 days). Each Udenyca patient (n = 496) was matched to 5 Neulasta patients. The efficacy endpoint was neutropenia rate, where neutropenia was defined as the presence of a neutropenia ICD-10 code (D70*), and/or an Absolute Neutrophil count less than 1,500. We are in the process of adding grade IV neutropenia (ANC < 500) to the tool. Results: Udenyca and Neulasta showed similar rates of neutropenia at 28.6% and 29.1% respectively (McNemar’s p-value 0.82). These rates are likely higher than those reported in the literature due to the very broad definition of neutropenia used in this study. Follow up will include neutropenia rates by grade. Conclusions: This proof of concept study established two key findings. First, that it is possible to do comparative effectiveness research at scale in order to drive value-based decisions in oncology care. Secondly, it confirms that we are seeing equivalent pegfilgrastim efficacy for neutropenia prophylaxis when comparing Udenyca, a biosimilar, to the originator agent.


BMJ Open ◽  
2014 ◽  
Vol 4 (11) ◽  
pp. e006945 ◽  
Author(s):  
Subhash Pokhrel ◽  
Silvia Evers ◽  
Reiner Leidl ◽  
Marta Trapero-Bertran ◽  
Zoltan Kalo ◽  
...  

2013 ◽  
Vol 84 (4) ◽  
pp. 795-802 ◽  
Author(s):  
Jongha Park ◽  
Connie M. Rhee ◽  
John J. Sim ◽  
Yong-Lim Kim ◽  
Joni Ricks ◽  
...  

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