title: Specialty pharmaceuticals: policy initiatives to improve assessment, pricing, prescription, and use.
abstract: The value of "specialty pharmaceuticals" for cancer and other complex conditions depends not merely on their molecular structures but also on the manner in which the drugs are assessed, insured, priced, prescribed, and used. This article analyzes the five principal stages through which a specialty drug must pass on its journey from the laboratory to the bedside. These include regulatory approval by the Food and Drug Administration for market access, insurance coverage, pricing and payment, physician prescription, and patient engagement. If structured appropriately, each stage improves performance and supports continued research and development. If structured inappropriately, however, each stage adds to administrative burdens, distorts clinical decision making, and weakens incentives for innovation. Cautious optimism is in order, but neither the continued development of breakthrough products nor their use according to evidence-based guidelines can be taken for granted.
authors.affiliation: James C. Robinson (james.robinson@berkeley.edu) is Leonard D. Schaeffer Professor of Health Economics, Division of Health Policy and Management, at the University of California, Berkeley.
authors.forename: James C
authors.initials: JC
authors.lastname: Robinson
authors.affiliation: Scott Howell is senior vice president, clinical services, at Cardinal Health Specialty Solutions, in Dublin, Ohio.
authors.forename: Scott
authors.initials: S
authors.lastname: Howell
mesh_terms: D017047:Cost Sharing / Q000191:economics / Q000379:methods; D016527:Drug Costs / Q000706:statistics & numerical data; D006291:Health Policy; D006801:Humans; D007348:Insurance, Health / Q000191:economics; D055553:Prescription Drugs / Q000191:economics* / Q000627:therapeutic use; D012051:Reimbursement Mechanisms / Q000191:economics; D014481:United States
chemical_list: D055553:Prescription Drugs
keywords: Biotechnology; Cost of Health Care; Medical technology; Pharmaceuticals; Research And Technology