Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to investigate the usage and substitution patterns, as well as clinical outcomes of brand and generic complex drug products. Complex generic products are those that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combinations. Doxorubicin hydrocholoride (HCl) liposome injection – a complex generic drug – is an antineoplastic agent indicated for patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy; for patients with AIDS-related Kaposi’s sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy; and for patients with multiple myeloma in combination with bortezomib. FDA scientists conducted a feasibility analysis using Sentinel to proactively monitor complex generic drug products in the postmarketing setting. The analysis assessed counts and baseline characteristics of users of brand and generic doxorubicin hydrochloride liposome injection, as well as non-liposomal doxorubicin hydrochloride injection, in the Sentinel Distributed Database (SDD).
Results indicated that most liposomal doxorubicin use in the SDD is identified using Healthcare Common Procedure Coding System (HCPCS) codes as opposed to National Drug Codes (NDCs). Brand products could not be differentiated from generic products using HCPCS codes. No additional Sentinel analyses were pursued because differentiation between brand and generic products, which is critical to this assessment, cannot be achieved with HCPCS codes.