Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to assess the feasibility of using Sentinel data to evaluate therapeutic equivalence of brand and generic tacrolimus, potentially resulting in different clinical outcomes between the brand and the generic product. Tacrolimus is an immunosuppressive drug indicated for prophylaxis of organ rejection in patients receiving allogeneic kidney, liver, or heart transplants. This exploratory Sentinel study aimed to assess feasibility of using switching patterns between brand versus individual generic products of tacrolimus oral capsule in transplant patients in the Sentinel Distributed Database (SDD) in order to evaluate therapeutic equivalence.
The first analysis captured liver, kidney, and heart transplant patients in the SDD, and found the majority of patients had less than two years of available follow-up time. The second analysis investigated the continuous use of brand and generic oral tacrolimus following a transplant event. Factors necessary for interpreting switching patterns were only partially captured or uncaptured in claims data (e.g., socioeconomic factors, changes in market share of each product over time, change of pharmacy and availability of generic products at each pharmacy). Given the limited amount of follow-up time available and limited descriptive data for products over time, no additional Sentinel analyses were pursued.