Pharmacy Times is pleased to introduce the first in a series of regular commentaries regarding the state of the field of specialty pharmacy. Many pharmaceuticals in this category provide sophisticated treatment for patients with complicated illnesses, such as multiple sclerosis and rheumatoid arthritis. Although the cost of these drugs is high, this sector of pharmacy is seeing tremendous growth. Pharmacy Times will continue to bring you regular updates in this field—the following is the first in the series from Russel Allinson of Therigy, LLC, the health care industry's trusted source for information, resources, and advisory services on specialty pharmaceutical and highcost therapies.
The origin of specialty pharmaceuticals can be traced to 3 different events. The first was enactment of the Orphan Drug Act of 1983 to encourage pharmaceutical manufacturers to investigate therapies that would treat conditions that affected smaller groups of patients (<200,000). The law offers a drug developer certain financial benefits and incentives in exchange for researching, developing, and getting a drug approved for a rare disease or condition. Since 1983, over 325 orphan drugs have been approved by the FDA.
Secondly, advances in biologic technologies fostered the creation of specialty products. No longer were drug discovery and production limited to chemical processes; advances in biologic processes enabled the development of drugs produced by biotechnology. Lastly, the development of genetic coding technology, discernment of the human genome, and an understanding of the genetic basis of disease, in conjunction with the aforementioned events, propelled the rapid development of biotech medications.
Although no specific criteria exist to define a specialty product, the following attributes are agreed as belonging to the class:
Given these attributes, it is easy to understand how these products migrated to pharmacies with the financial resources and the technical and professional experience to manage them successfully. Specialty pharmacy has often been compared with medicine, where a specialization "an inch wide and a mile deep" develops quickly. Two early examples in the 1990s were Accredo and Stadtlanders, who grew multimillion-dollar businesses based on 1 or 2 therapies.
As knowledge of specialty pharmacies grew, manufacturers with new specialty products sought them out as ideal pharmacies to launch their new products, further reinforcing the concept and adding to their reputation. Discussion of these new products will be a subject of future articles.