Direct information about the patterns of use of anti-IgE therapy is not readily available. An indirect method of assessing patterns of use is to analyze the prior authorization strategies of MCOs associated with this particular therapy. The use of biologic injectables, such as omalizumab, is frequently subjected to prior authorization procedures that ensure medical appropriateness. A review of these prior authorization procedures, available as published documents, provides insight into patter ns of use via the criteria that must be met for coverage of the drug. Because of the high costs associated with biologic injectables, criteria for coverage have a strong influence on patterns of clinical use.
An assessment of prior authorization procedures for 40 commercial health plans covering more than 30 million members determined that plans representing almost 90% of these covered lives had prior authorization procedures consistent with the clinical practice guideline updates recommended by the expert panel, the FDA package insert guidelines, or a less restrictive procedure.
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The survey findings show that most patients in these plans have access to omalizumab in the clinical situations deemed “appropriate” by the expert panel of clinicians. The findings also suggest that the intellectual process of formulating these guidelines may have a positive effect on the clinical practice standards supported by commercial health plans as well as by clinicians.
An informal poll of the expert clinicians who helped to develop the guidelines for omalizumab sheds light on prescribing patterns and how allergists and pulmonologists are addressing some of the unanswered questions. Most experts assigned high priority to “high doses of other medications ineffective in controlling symptoms” (80%) and “reducing dependence on steroids” (100%) in their decisions to prescribe anti-IgE therapy. When asked at which steroid dosage levels they considered prescribing anti-IgE therapy when patients’ symptoms failed to be controlled, the experts most frequently indicated ” drug salmeterol/canadian fluticasone 50/500 mcg” (e.g., Advair Diskus, GlaxoSmithKline) (33.3% of the time) and “trial of corticosteroids” (33.3% of the time).
While questions remain—for instance, a reasonable end-point for a successful course of therapy has yet to be established—the respondents believed that the process of developing an interim guideline in the absence of national standards or extensive experience is helpful in determining appropriate patterns of the use of a novel agent.
In clinical trials contributing a total of more than 2,037 patients with mild-to-severe allergen-mediated asthma, anti-IgE therapy was well tolerated, and no complications associated with reduced circulating IgE or antibodies against the drug were observed.The incidence of adverse drug events (ADEs) was similar among treatment groups, and no drug-related serious ADEs were reported. In general, treatment with anti-IgE was well tolerated, and both patient and physician assessments of the treatment were positive.
As with any protein, there is a potential for local or systematic reactions to occur. Patients should be advised to seek prompt medical attention in the event of an allergic reaction. Parasitic infections may result in elevated serum IgE concentrations, and the effects of anti-IgE in the presence of known concurrent parasitic infections are being studied.
Investigations are ongoing to identify any association between anti-IgE treatment and the incidence of malignancies. Current long-term data do not indicate such an association.