Michael Russo

Biologics and specialty pharmaceuticals, which typically target small patient populations, have historically necessitated a high per-patient cost to justify their R&D investment and expensive manufacturing and packaging processes.

Affordable healthcare has become a leading political and social hot button in the United States, and managed care organizations (MCOs) have responded by seeking to reduce pharmaceutical expenses to rein in rapidly increasing costs.

The historic divide between academic research and the pharmaceutical industry is disappearing as new research collaborations, drug discovery programs, partnerships, and an evolution in attitudes erases the distinctions that have kept the two at arm's length.

Managed care organizations (MCOs) and pharmacy benefit managers (PBMs)-representing 110 million US patients-have adopted new guidelines for formulary submissions. As a result, they now reject 40 percent of new drugs. Those standards, the most visible component in an approach called outcomes-based access, indicate a revolutionary change in the formulary decision making process that affects 46 percent of the insured population. Many pharmaceutical companies are being caught by surprise.