Box 5. Box 5 Dangers posed by OBA excesses

Clearly, OBA policies carry the danger of swinging the pendulum too far in the opposite direction. There is a real risk that, taken to inappropriate extremes, OBA policies will overly restrict access and choice to patients with reasonable medical need, perhaps resulting in diminished outcomes and higher costs (in some cases).

All stakeholders can agree that we must hold the system to high standards, directing dollars to the highest value opportunity and encouraging safe and effective use of the right treatments for the right patients. These are the principles espoused by an outcomes-based system. However, as insurance programs roll out OBA-based programming, there are some real negative consequences that come with policies that go too far or are engaged without appropriate planning.

Denying patients medically necessary care. Patient care must always come first and cannot be risked in the face of cost containment strategies. The system has already moved quite far from the heart of what insurance as a concept is meant to represent. A system is emerging in which 'coverage' does not equal 'access'. Even if a particular biologic, for example, is covered by an employer-funded policy, several programs will deny patient access to that drug, even in the face of it being considered medically necessary. Formularies, patient out-of-pocket expenses and prior authorizations have evolved well beyond their original intent. Managed-care executives, with whom we speak regularly, do not deny that demanding very high patient copayments, in the hundreds or even thousands, for example, presents a significant barrier to receiving treatment even for the eligible and those at disease risk. Step therapy programs, likewise, may necessitate that a patient be put on an inferior drug and fail before being allowed access to the state of the art. We have worked extensively with patient groups across many targeted disease areas, including psoriasis, rheumatoid arthritis and hemophilia; some affected individuals suffer disease progression and more deleterious outcomes as they move through these machinations and perhaps even give up.

Increasing downstream medical costs. In many cases, policies that delay or deny care in the name of pharmacy cost-savings will only create longer-term medical cost increases. Because pharmacy benefit managers do not share any risk on the medical side, it is in their best interest to keep drug costs down despite any downstream increase in medical expenditures. We have learned through our own payer studies that even in integrated insurance companies, with their own internal pharmacy benefit managers and specialty pharmacy, many of these decisions are made in a compartmentalized fashion. Though they strive to fulfill this mission, their systems and resources simply aren't adequate to perform all necessary integrated analyses of costs and outcomes. If the consequences of a policy are not fully understood in a rigorous fashion, perhaps they should be delayed or shelved.

Usurping the role of the physician. One critical fact must be restated. The central role of the physician in making clinical care decisions must be preserved and kept paramount. Unfortunately, we have already seen their role often usurped by clinical guidelines and usage policies. As early as 1999, physician groups at the American Association for the Study of Liver Diseases (Alexandria, VA, USA), for example, expressed fear that guidelines were being misused as categorical rules of treatment, invoked to deny physicians the opportunity to individualize patient care as they saw fit. Evidence-based medicine should not be abused in this fashion.

Stifling innovation. Taken to their extreme, OBA policies can stifle the diffusion of innovation, allowing access to revolutionary products only at a premium. If this occurs, investment in medical technologies and drugs will simply be too risky in many disease areas. Furthermore, this must not be allowed to trickle upstream, making areas of applied research less viable because reasonable treatments already exist. All major players in the system must strike a balance, understanding that innovation is often incremental, and setting value expectations, pricing and access accordingly.