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Betting the House on Orphan Drugs

Pharmaceutical Commerce, Nancy Young and Adam Blatney

The role of RWE derived from analysis of and formal studies involving real-world data (RWD)—such as electronic health record (EHR) and claims databases, published literature, laboratory testing and prescription data, patient-reported outcomes, registries, digital health, and wearable device data and more—to support the orphan drug space continues to become more multifaceted. Small trial populations and expedited approval processes often translate to a dearth of clinical insights at market launch, and this can impact physician prescribing behaviors, patient acceptance, and payer coverage, Nancy Young, vice president of commercialization services on AmerisourceBergen’s global consulting team, points out. “RWE studies have become a necessity to ensure continued commercial success among orphan drugs, and to inform both clinical decision-making and coverage negotiations,” she says.

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