Variability In Formulation, Shelf-Life, And Cost Of Compounded Budesonide For Eosinophilic Esophagitis: Survey Of Compounding Pharmacy Practices

INTRODUCTION: Recommended first-line therapy for eosinophilic esophagitis (EoE) includes topical corticosteroids. However, there are currently no Food and Drug Administration (FDA) approved pharmacologic therapies and off-label use can be prohibitively expensive. Compounded budesonide suspension may be a more affordable option, but there is no standardized formulation and little is known about the use of compounded topical steroids for EoE. We aimed to characterize compounding pharmacy practice patterns and costs to patients. METHODS: We conducted a telephone survey of all compounding pharmacies in Michigan identified using directories from the state licensing board and professional societies (Professional Compounding Centers of America, Alliance for Pharmacy Compounding). Pharmacies were queried about practices and costs of compounded budesonide for EoE, including medication concentrations, preferred suspensions or drug vehicle, and cost to patients. RESULTS: Of 68 compounding pharmacies identified, 62 responded (90% response rate) and 19 (31%) had dispensed budesonide suspension for EoE, most often prescribed by gastroenterologists (42%). Only 16% routinely tested the quality and accuracy of their budesonide suspension, but all used United States Pharmacopeia (USP) grade budesonide. The majority (67%) were not aware of and there were wide variations in medium and drug concentrations among the 33% that reported using the preferred formula. Commonly used suspension media were methycellulose gel (28%), Mucolox (17%), Ora-plus, Poloxamer, Syrspend, and water. Cellulose (28%) and xanthan gum (11%) were commonly used thickening agents and flavoring or sweeteners were often added. Medication concentrations varied across facilities (median 2mg/10mL, range 2-5mg/mL, min 0.67mg/mL, max 10mg/mL). A 30-day expiration date was recommended by most (67%), but 28% allowed for 90-day or longer use. Median cost for a 30-day supply was $60 (range $40-$80); 42% reported insurance coverage for some patients. CONCLUSION: Few compounding pharmacies offer budesonide suspension and there are substantial variations in formulations dispensed. Given the lack of standardization and efficacy studies for these varied budesonide suspensions, an FDA-approved topical corticosteroid for EoE would be welcome. However, if such a medication is cost prohibitive, then compounded budesonide may still be a more affordable treatment option.Figure 1.: Compounded budesonide suspension sources in Michigan.