Commentary: Specialty Pharmacy: The Whole Package

APRIL 01, 2009
David M. Franklin, MSA

The specialty drug market certainly has everyone’s attention. Depending upon which study you want to believe, the specialty drug market is the fastest growing area of health care in terms of cost, experiencing between 20% and 40% growth per year. Providers, payers, and drug manufacturers have all taken note, and are scrambling to manage this emerging environment. The rate of introduction of new therapies is stunning, and keeping up with the changes represents a significant strategic challenge to all parties. The individuals who manage this developmental phase most skillfully will ultimately benefit the most.

It is difficult to discuss something without first defining it, and clarifying exactly what a specialty drug is can be particularly challenging, as there is no standardized definition. In general, specialty drugs are defined by:

  • High cost: Many such drugs cost hundreds or thousands of dollars per treatment.
  • Chronic diseases: Many are used to treat diseases where therapy is provided over a longer period of time.
  • Complex care: The clinical acuity of related treatments is often high, requiring the provision of an abundance of professional services.
  • Handling requirements: Refrigeration, special storage requirements, and the ability to be mailed are often cited as defining elements.
  • Biologically based: Drugs based on protein molecules derived from living cells or other such biologically based medication therapies are often classified as specialty drugs.
  • Specific administration requirements: Specialty drugs are often injected or infused, and also may be administered transdermally or via inhalation.

Benefit plan and reimbursement infrastructure vary significantly, alternating between standard pharmacy and major medical benefits. Whereas pharmacy has historically been viewed as a product-based modality, the service component of specialty drug administration is often significant.

A pharmacy’s patients can be quite diverse as well, each with divergent expectations. For instance, hospitals need a safe and effective site of service to discharge inpatients; drug manufacturers want high-quality providers that can supply outcomes information; and patients want to receive the highest quality of care. Also, pharmacies desire assurance of reimbursement and a fair return on investment.

A pharmacy seeking to enter these potentially profitable markets must be able to serve all the needs of these disparate constituents. Key elements to deliver include:

Ability to Access Applicable Drugs

In theory, this is accomplished via contracting with the drug manufacturers, but in practice these agreements are difficult to acquire, as the manufacturers have restricted distribution channels, detailed data submission prerequisites, and extensive clinical program requirements. At minimum, expect to be required to provide complete patient demographics; detailed clinical outcomes information; patient and physician satisfaction survey results; and data submitted on a timely basis and in a format that meets all manufacturer requirements.

Ability to Provide All Service Components

Successful providers in the specialty drug arena must be able to offer not only products and data, but also comprehensive clinical services including pharmacokinetic dosing, which requires access to lab and other diagnostic test results; sterile compounding, including meeting the requirements of USP 797; nursing services where applicable; and comprehensive patient education, which is considered a core component of any effective disease state management program.

Ability to Get Paid

This means not just paid, but paid fairly and with respect and consideration of all of the components that go into providing such a comprehensive and clinically acute service. Health plans that are accustomed to the more traditional role of pharmaceutical intervention often do not realize the cost and level of service necessary for an effective specialty drug program. This has led to attempts to commoditize the field into nothing more than a derivative of cost of goods sold. Providing education to those responsible for reimbursing health-related services is a key component of a specialty drug program.

If you can master this environment by developing comprehensive patient care programs, gaining access to applicable medications, and acquiring payer source contracts, you may be able to play a role in the specialty drug market.