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2006: the state of biologics.

In a room filled with managed care medical and pharmacy directors, the refrain was loud and clear: How are we going to pay for biologics? 
 
Payers can’t afford them all, and employers do not yet fully grasp what the increased use of biologic therapies means for them. Self-insured plans can’t handle biologics, and municipal health plans are having a hard time providing ordinary drug benefits. 
 
A tidal wave of specialty drugs, as one speaker called it, will hit in another four years — 60 percent of specialty drug spending will be for 4 percent of the population — pushing per-member, per-month costs ever higher. 
 
These stark realities and more were raised at CBI’s third annual Specialty Pharmaceuticals, Biotech Therapies, and Injectables Forum, held in Washington, Jan. 23 and 24. Though biologics have been on payers’ radar screens for some time, far more questions were asked than answers given. 
 
As the conference went on, other concerns bubbled to the surface. For physicians, there’s a realization that it’s not how you manage specialty drugs, it’s how you manage your practice. Hospital outpatient services for infusibles and injectables and how to manage them makes for another changing and contentious scene. Average sales price and specialty distribution issues have to be reckoned with now that Medicare Part D is front and center. And, like it or not, the costs involved beg the question of whether American health care is moving closer to a single-payer system. If so, where does that leave payers? 
 
And don’t count on cost relief from follow-on products soon, despite the recent approval in Europe of a copycat human growth hormone, and with interferon alpha and beta, erythropoietin, and colony-stimulating factor not far behind. 
 
Evidence-based medicine can help decision makers begin to answer some of these questions. Data gathered by the Cochrane Collaboration and Database of Abstracts of Reviews of Effects (DARE), for example, can be used in the absence of long-term outcomes data for many emerging biologic therapies. 
 
The one area that may have the biggest effect on health benefits— and that will mandate realignment of that system — is genomics testing, determining even before birth what and when diseases will hit an individual. Would you tell a 25-year-old woman that by the time she reaches 55 she is likely to develop AML? Should she worry for 30 years or seek treatment to avoid its manifestation? No easy questions, no easy answers. 
 
Finally, to make our heads spin, nanotechnology is looming. Wow! 
 
One more thing is clear, based on the discussions and the questions people asked: Biotechnology Healthcare is ahead of the curve in showcasing these issues — as our current issue attests — as part of our mission to guide readers in making informed decisions. We intend to keep it that way.