This illustrates that medications are the largest cost component of asthma care, which underscores the importance of incorporating effective medical management into clinical guidelines for asthma.^1,2

Incorporating New Technologies into Established Guidelines
Despite internationally recognized, evidence-based guidelines for managing asthma,^3-6 the disease remains inadequately controlled in a significant number of patients.⁷ Factors may include access to care, comorbid conditions, and issues involving patient and physician adherence. Other possibilities are that better treatment regimens have yet to be fully elucidated, or that national standards have yet to reflect updated knowledge of recently approved treatment modalities.

One such novel therapeutic approach is a recombinant deoxyribonucleic (DNA)-derived, humanized monoclonal anti-immunoglobulin E (IgE) antibody that inhibits the binding of IgE to the surface of mast cells and basophils.This inhibition limits the release of inflammatory mediators (i.e. histamine, prostaglandins, and leukotrienes), which themselves initiate an allergic response that includes mucosal edema and smooth muscle contraction. In multiple studies, omalizumab has proven to be an effective treatment for moderatepersistent to severe-persistent asthma, improving symptoms while reducing exacerbations and healthcare utilization.

At the completion of phase III trials for omalizumab, its developers (Genentech, Inc. and Novartis Pharmaceuticals) and the Department of Health Policy at Jefferson Medical College convened a panel of asthma experts to revisit the 1997 National Asthma Education and Prevention Program (NAEPP) guidelines, and to review the potential role of IgE blocker therapy within these current asthma guidelines.The expert panel consisted of leaders in the fields of allergy and immunology, pulmonology, pediatrics, and pharmacology, as well as medical executives who represented major managed care

organizations.⁸ The panel endorsed the 1997 NAEPP recommendations for mild-intermittent and mildpersistent asthma,³ but recommended several additions to the remainder of the guidelines in light of the new technology (see Table 1).

First, the panel acknowledged that patient nonadherence probably contributes to the lack of control in the moderate- and severe-persistent asthma categories. Because of this, the panel recommended that guidelines include an aggressive and comprehensive patient education and evaluation program for these patients, especially those unable to achieve optimal control. This program would include instruction on the use of devices, environmental control and avoidance measures, rescue action plans, and techniques for self-management and adherence. Second, the panel questioned the value of distinguishing between moderate- and severepersistent asthma. The panel of experts agreed that making a distinction between these two groups is difficult in clinical practice, and even if possible, the panel felt that differences in the associated treatment regimens were so unnecessarily confusing that they would probably lead to patient non-adherence anyway. Because of these issues, the panel recommended eliminating the distinction between moderate- and severe-persistent asthma groups, opting instead for standardization of therapy among patients with suboptimally controlled asthma.