In an analysis and commentary published in the October issue of Health Affairs, Dr. James C. Robinson, Leonard D. Schaeffer Professor of Health Economics at the UC Berkeley School of Public Health, describes public and private sector opportunities to enhance the value of specialty pharmaceuticals—drugs to treat complex and life-threatening conditions such as cancer and rheumatoid arthritis.
The article, co-authored by Dr. Scott Howell, senior vice president of clinical services at Cardinal Health Specialty Solutions, analyzes the five principal stages specialty pharmaceuticals must pass to get from the laboratory to the bedside. These include regulatory approval from the Food and Drug Administration for market access, insurance coverage, pricing and payment, physician prescription, and patient engagement.
According to the commentary, if structured appropriately, each stage can improve performance assessment, reduce access barriers, and support continued research and development. However, if structured inappropriately, the stages add to complicating the administrative burden, distorting clinical decision making, and weakening incentives for innovation.