title: The impact of specialty pharmaceuticals as drivers of health care costs.
abstract: The pharmaceutical industry is shifting its focus from blockbuster small molecules to specialty pharmaceuticals. Specialty pharmaceuticals are novel drugs and biologic agents that require special handling and ongoing monitoring, are administered by injection or infusion, and are sold in the marketplace by a small number of distributors. They are frequently identified by having a cost to payers and patients of $600 or more per treatment. The total costs of the new agents are likely to have a substantial impact on overall health care costs and on patients during the next decade, unless steps are taken to align competing interests. We examine the economic and policy issues related to specialty pharmaceuticals, taking care to consider the impact on patients. We assess the role of cost-sharing provisions, legislation that is promoting realignment within the market, the role of biosimilars in price competition, and the potential for novel drug development paradigms to help bend the cost curve. The economic aspects of this analysis highlight the need for a far-reaching discussion of potential novel approaches to innovation pathways in our quest for both affordability and new technology.
authors.affiliation: Bradford R. Hirsch is an assistant professor of medicine at Duke University, in Durham, North Carolina.
authors.forename: Bradford R
authors.initials: BR
authors.lastname: Hirsch
authors.affiliation: Suresh Balu is a manager of strategy and innovation at the Duke Translational Medicine Institute, Duke University.
authors.forename: Suresh
authors.initials: S
authors.lastname: Balu
authors.affiliation: Kevin A. Schulman (kevin.schulman@duke.edu) is a professor of medicine and the Gregory Mario and Jeremy Mario Professor of Business Administration at Duke University.
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Schulman
mesh_terms: D001688:Biological Products / Q000191:economics* / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000191:economics / Q000627:therapeutic use; D017047:Cost Sharing; D016527:Drug Costs / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D004465:Economic Competition; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D007348:Insurance, Health / Q000191:economics / Q000706:statistics & numerical data; D007880:Legislation, Drug; D055553:Prescription Drugs / Q000191:economics* / Q000627:therapeutic use; D064876:Safety-net Providers / Q000191:economics / Q000331:legislation & jurisprudence; D014481:United States
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D055553:Prescription Drugs
keywords: 340B; Cancer; Cost of Health Care; Health Economics; Specialty Pharmaceuticals