Evaluating biologics and their biosimilars using a distributed research network to demonstrate real-world outcomes.
Pawloski P, Haynes K, Kent D, McMahill-Walraven C, Panozzo C, Pindolia V, Lockhart C, Brown J, Mendelsohn A, Barr C, and Eichelberger B. Evaluating biologics and their biosimilars using a distributed research network to demonstrate real-world outcomes. J Manag Care Spec Pharm 2018; 24(10 A):S96.
Journal of managed care & specialty pharmacy
BACKGROUND: The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was initiated in anticipation of biosimilars entering the U.S. market. OBJECTIVE: To present descriptive and comparative analyses of innovator compounds and biosimilars to address patient and physician concerns and potentially facilitate greater acceptance and adoption of biosimilars. METHODS: The BBCIC leverages Sentinel's distributed research network (DRN) and the collaboration includes 18 founding member organizations from managed care integrated delivery networks, pharmacy benefit managers, and industry sponsors. Initial descriptive analysis (DA) studies were conducted to characterize the DRN data. Primary outcome measures included: (1) febrile neutropenia hospitalizations among first cycle granulocyte-colony stimulating factor (G-CSF) prophylaxis for breast and lung cancer (2) adverse events following erythropoietin stimulating agent (ESA) use in hemodialysis; (3) major adverse cardiac and hypoglycemia events following long-acting insulin (LAI) use in Types 1 and 2 diabetes and; (4) hospitalizations for serious infections following anti-inflammatory (AI) use for rheumatoid arthritis, psoriatic and gastrointestinal conditions. RESULTS: (1) G-CSF prophylaxis can be discerned from treatment and rare safety events were identified; (2) DRN ESA data lack granularity and future studies will be conducted using the Medicare ESRD data set; (3) major adverse cardiac and hypoglycemia events associated with LAIs are comparable to other observational trials; and (4) serious infection outcomes are comparable to other AI observational trials. In addition, it was identified that methods workgroups are needed to define best practices for switching patterns in comparative effectiveness research (CER) studies, International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CD) to ICD-10-CM mapping will be needed, and monitoring of data partner capture of National Drug Code and Healthcare Common Procedure Coding System codes is necessary. CONCLUSIONS: Outcomes comparable to those in the published literature were demonstrated for G-CSFs, LAIs, and AIs. ESA data do not contain needed granularity and future research will use alternative data sources. Following sufficient biosimilar exposures, CER studies will be initiated to assess the safety and effectiveness of biosimilars compared with innovators. In preparation for the planned CER studies, workgroups are identifying best practices to be implemented.