title: A review of approaches for the management of specialty pharmaceuticals in the United States.
abstract: With increased innovation and development of specialty pharmaceuticals, the US and global healthcare industries are looking to implement appropriate management strategies to control both utilization and costs. Specialty pharmaceuticals are high-cost medications that treat complex, chronic, rare, and difficult-to-manage conditions. These drugs require special drug handling, appropriate clinical outcomes monitoring, and effective cost controls. The primary scope of this article is to discuss various strategies being implemented for specialty pharmaceutical utilization and cost management and correlated outcomes in the USA; these outcomes include enhanced health insurance plan benefit designs with formulary modifications and greater patient cost burden. Additional methods to manage specialty pharmaceuticals include the use of specialty pharmacies for drug distribution, increased emphasis on coordination of care and evidence-based medicine, as well as healthcare reform and regulations. Healthcare spending, both in the US and globally, continues to increase, with a rising proportion of drug spend towards specialty pharmaceuticals. Continued specialty pharmaceutical innovation and introduction of biosimilar products will evolve the currently utilized management strategies for these drugs.
authors.affiliation: University of the Sciences, Mayes College of Healthcare Business and Policy, 600 S. 43rd Street, Philadelphia, PA, 19104, USA, b.patel@usciences.edu.
authors.forename: Bijal Nitin
authors.initials: BN
authors.lastname: Patel
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Audet
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000191:economics; D003363:Cost Control / Q000639:trends*; D016527:Drug Costs; D019317:Evidence-Based Medicine / Q000191:economics; D017048:Health Care Costs / Q000639:trends; D006801:Humans; D054539:Medication Therapy Management / Q000191:economics*; D058991:Patient Protection and Affordable Care Act / Q000191:economics; D010593:Pharmaceutical Services / Q000191:economics; D014481:United States
chemical_list: D059451:Biosimilar Pharmaceuticals