CASE STUDY

The established pharmaceutical company, CSL Vifor, was developing a new drug to treat the condition of CKD-associated uremic pruritus (CKD-aP) affecting ~20-40% of patients on hemodialysis. In Phase 3 clinical trials, this new drug Difelikefalin had been shown to decrease the moderate to severe effects of this condition after 12 weeks of treatment.

After having been used in dialysis clinics as part of routine care, the goal was to assess real life effectiveness in hemodialysis patients being treated with the drug as part of routine clinical care.

In consultation with the pharmaceutical company, Frenova recommended a retrospective analysis of data about hemodialysis patients who received this new drug.

Frenova's team of epidemiologists, statisticians and physicians used its analytical expertise and its unique access to the Fresenius Medical Care patients database including the electronic health records to conduct the study.

The patients included in the analysis were hemodialysis patients between the ages of 18 and 89 years who received a specific regular dose of medication and had documented the effect that occurred. Additional associated medical information of relevance was also analyzed.1

Read more about the study here: https://www.nejm.org/doi/full/10.1056/NEJMoa1912770 

The data were able to show in a real life setting that patients experienced a decrease in the condition's severity, which was remarkable.

After finalization of this initial study, two additional retrospective data analysis projects were decided upon. These subsequent projects were designed to address aspects of Health Economics and Outcomes Research (HEOR) and investigate clusters of interdependent symptoms.

Without Frenova's analytics services and access to Fresenius Medical Care's patient database, it would have been very difficult for CSL Vifor to produce retrospective results that could be used for publication to the scientific community. Real World Evidence can also be used to inform regulatory agencies or payor organizations.