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Abstract
Aims: Switching drug manufacturers in transplant patients may require an increased intensity of therapeutic monitoring, leading to additional healthcare visits, associated laboratory tests, and perhaps hospitalizations. As real-world studies examining the interchangeability of tacrolimus from different manufacturers are limited, the purpose of this study was to examine the healthcare resource utilization (HRU) and economic impact of tacrolimus-switching in kidney transplantation.
Materials and methods: This cross-sectional, retrospective study examined HRU and healthcare costs (HCCs) among patients with a kidney transplant who were prescribed tacrolimus from fixed-source (FS) vs variable-source (VS) manufacturers using claims data from the large US health plan Humana from October 1, 2012, to December 31, 2013.
Results: Overall, 1,024 patients were identified (FS: n = 674, 66%; VS: n = 350, 34%). The number of therapeutic drug monitoring (TDM) events for the VS group was 13% greater than for the FS group after controlling for demographics, comorbidity score, and number of medications (incidence rate ratio = 1.13, p = .033). Adjusted total HCCs were 9% lower for VS (US$28,054 vs US$30,823, p = .045). In the unadjusted analysis, VS had greater emergency department (ED) utilization (45% vs 35%, p < .002). In the VS group, the mean (standard deviation [SD]) number of days from manufacturer switch to first outpatient visit was 23.8 (33.6), and the number of days (SD) to first TDM event was 43.6 (56.2).
Limitations: Study limitations include the lack of availability of many transplant-specific variables within the Humana database, potential errors/omissions in claims coding, and restriction of cross-sectional data examination to a 1-year period.
Conclusions: VS patients had greater TDM and lower total HCCs. Further research is warranted to understand the drivers of ED use among the VS group, and to determine factors associated with delayed TDM after regimen modification. Opportunities may exist to improve the quality of care for patients receiving immunosuppressant treatment with tacrolimus.
Transparency
Declaration of funding
This study was funded by Astellas Pharma Global Development, Inc.
Declaration of financial/other interests
The authors of this manuscript have conflicts of interests to disclose. This research was conceived, funded, and carried out collaboratively by Humana Inc., Astellas Pharma Global Development, Inc., and Comprehensive Health Insights, Inc. (CHI). The research concept was approved by the Joint Research Governance Committee of the Astellas–Humana Research Collaboration, comprised of Astellas, Humana, and CHI employees. Comprehensive Health Insights, Inc., a wholly-owned subsidiary of Humana Inc., received compensation from Astellas in connection with the conduct of this research and development of this manuscript. SB is employed by CHI and reports grants from various pharmaceutical companies; EL is a former employee of Astellas; PK is a former employee of CHI; BS is employed by CHI, is a stakeholder in Humana Inc., and in the course of his employment has conducted research sponsored by Pfizer, Novo Nordisk, Shire, Janssen, and Allergan; BF, JSc, GT, and JSp are employees of Astellas Pharma Global Development, Inc. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
This study was funded by Astellas Pharma Global Development, Inc. James Wallis, MRes, of Cello Health MedErgy provided editorial support during the development of the manuscript. Editorial support was funded by Astellas Pharma, Inc.
Previous presentations
These data have been previously presented as a poster at the 2015 American Transplant Congress in Philadelphia.