Managing the expanded use of biologics across therapeutic areas: an example from b-cell targeted therapies.

Greater understanding of disease pathology at the molecular and cellular level has enhanced the roles of various proteins in disease pathogenesis. Because so many diseases have common physiologic pathways, many biologic therapies have been found to work in multiple therapeutic areas, particularly cancer, inflammation, infections, and metabolic and blood disorders. Thus, the search for agents to inhibit or block these critical therapeutic agents has been accelerated. This supplement reviews the factors contributing to the enormous growth of biotechnology drugs--both those currently marketed and those in late-stage development--from a clinical and managed care perspective. Specifically, the growth of expanded indications for drugs approved by the US Food and Drug Administration (FDA) will be examined, along with the challenges of managing biotechnology therapies being used beyond their original indications. A review of currently marketed biologics under investigation for new indications will be presented, along with a discussion of the implications of expanding indications and the resultant impact on managed care organizations in terms of cost, benefit design, access management strategy, safety and efficacy, and other pertinent issues. Managed care executives will face the challenge of making critical formulary decisions within the context of ever-increasing biologic options, including greater utilization of biotechnology drugs, more biologics for common conditions, and expanded indications for FDA-approved drugs.