Specialty Pharmaceuticals – Utilization Management

Abstract

Specialty medications are complicated, treat complicated diseases, and are costly. Yet, even if their cost was to be decreased by 50%, many of the specialty medications would still be too costly either with high copays, or be unaffordable under any circumstance. Hence the use and oversight of Specialty medications is more complex than just cost: effectiveness, risk and cost must be evaluated concurrently. Utilization is actually the great multiplier. No matter the individual cost of a medication, uncontrolled expansion of medication use leads to more drugs, and therefore, higher drug spend. Utilization management of Specialty medications is, thus, a multifactorial process that is as important as cost management. Human Insulin was the first of the so-called “Specialty Medication.” Specialty treatments followed for orphan and previously untreated diseases. Treatments for chronic diseases followed where Specialty medications replaced older small molecules. The major complication was that the cost of these new treatments rivals, and often exceeds, acute care hospital stays. Unfortunately, evidence has not always matched the comparative benefits of Specialty medications over their small molecule counterparts. As a result, the explosion of new Specialty medications has also stimulated the need for strong evidence that these medications are significant improvements over prior therapies. If so, how can they be affordable? Utilization management of Specialty medications shares many of the same elements that have been used for decades to monitor and manage all treatments; namely, prior authorization, drug utilization review, step therapy, and quantity limits. This paper will examine the approach to utilization management of Specialty medications with the goals of providing a template for providers to participate in this management as well as to understand the metrics applied when these medications are submitted for payment.