Until now, the US oncology drug market has operated in its own economic universe. It's been a lucrative niche business, characterized by premium prices for drugs that address small, desperate patient populations, often coping with fatal diseases that lack effective therapies. The playing field, however, is changing rapidly, with multiple implications for manufacturers. Scientific progress-and money--are at the heart of the change. Changes in oncology reimbursement will affect pharmaceutical manufacturers' relationships with providers and payers as well as their development and commercialization strategies. v

As biotech products ripen, manufacturers facing the prospect of launching complex, expensive drugs are turning to specialty pharmacy providers for help. A new breed of business, they provide clinical and logistical support. The recent entry of PBMs into the specialty pharmacy arena, along with new Medicare rules, is likely to accelerate pricing pressure on manufacturers and affect their relationships with distributors, payers, and providers.

The steady stream of new biologics is putting increasing pressure on both payers and manufacturers to re-evaluate long-standing ways of doing business. The average retail pharmacy--or PBM for that matter--isn't equipped to deal with complexities related to these drugs and hence the need for SPPs--special pharmaceutical providers. SPPs have started up in abundance in recent years to handle therapeutics with difficult administrative regimens and high costs. Biotech companies are using them in a variety of ways.