Variability in practices of compounding budesonide for eosinophilic esophagitis

STRUCTURED ABSTRACT

INTRODUCTION:

Little is known about the use of compounded steroids for eosinophilic esophagitis (EoE).

METHODS:

We conducted a telephone survey of all compounding pharmacies in Michigan and queried about practices and costs of compounded budesonide for EoE.

RESULTS:

Of 68 Michigan pharmacies, 93% responded, and 20 (29%) offer compounded budesonide suspension for EoE. Formulations, dose, and instructions for use varied across pharmacies. The mean cost for a 30-day supply was $74.50.

DISCUSSION:

Although few compounding pharmacies offer budesonide suspension and there are substantial variations in formulations, this may be a significantly more affordable treatment option for many.

INTRODUCTION

First-line pharmacologic therapies for eosinophilic esophagitis (EoE) are associated with histologic and symptom response, improved quality of life, fewer esophageal impactions, and are recommended as long-term therapy.^1–3 Available topical corticosteroids for EoE include budesonide respules mixed with mucoadhesive vehicles, fluticasone diskus, and swallowed steroids via metered dose inhalers (e.g., fluticasone, ciclesonide).^4,5 There are currently no Food and Drug Administration-approved medications for the treatment of EoE and the off-label use of these effective steroids can be prohibitively expensive. A 6-week course of budesonide respules 1mg twice daily is estimated to cost $1,613-$1,723 and in a recent cost analysis, the median cost was $2,316 per quarter, representing a potentially unsustainable financial burden for patients requiring maintenance therapy.^6–9 Alternatively, compounded topical corticosteroids may be an effective and more affordable option for some patients seeking medical therapy.^10,11 As there is no standardized formulation, compounding practices vary between pharmacies and little is known about the use of compounded topical corticosteroids for EoE.¹²

We aimed to survey compounding pharmacies in the state of Michigan to describe practice patterns around budesonide suspension for EoE, patient education and counseling, and costs to patients.

METHODS

In this cross-sectional telephone survey study of all compounding pharmacies in the state of Michigan, pharmacies were identified from the state licensing board and professional societies. The University of Michigan School of Medicine Institutional Review Board reviewed and deemed this research as not regulated. The survey consisted of 24 questions about formulation, dispensing, cost, and education related to compounded budesonide suspension (Supplementary Appendix). The survey was developed by the authors and iteratively refined with feedback from two practicing compounders with experience in budesonide suspension for EoE. Pharmacies were individually contacted by telephone and participation was voluntary without financial incentives. The data were collected between April – July 2020. Descriptive statistics of categorical and continuous variables, and multiple response questions were performed. A favored or preferred formula was defined as one that is commonly accepted or more efficacious.

RESULTS

Of the 68 compounding pharmacies identified, 20 (29%) compounded budesonide suspension for EoE (93% response rate) and were analyzed. Pharmacies were predominantly located within urban counties (17, 85%), had a mean number of 3.4 patients with active prescriptions (SD 3.6, median 2), and gastroenterologists were the most common prescribers (45%). Other prescribers included primary care (20%), allergy (5%), and otolaryngology (5%); prescriber specialty was unknown in 25%.

Total daily budesonide doses varied across facilities (mean 2.1 mg/day; SD 0.97; median 2; interquartile range (IQR) 1.5, 2.25), administered once daily (35%) or split twice daily (65%). The most common suspension media was Methocel or cellulose gel (38%). Others included Mucolox (19%), Oraplus (10%), xanthan gum (10%); less commonly Poloxamer, Syrspend, Versabase, and saline (Figure 1). Carboxymethylcellulose thickener (15%), flavoring (70%), and Stevia (40%) were common additives. Few pharmacies (15%) added other medications (e.g., mupirocin, montelukast, other steroids). Nearly half (40%) were aware of a favored or preferred formula for EoE, but among those, total daily doses (mean 2.3 mg/day, SD 0.75) and suspension media also varied.

Figure 1.

Common budesonide suspension media and cost for 30-day supply

All pharmacies provided patient education and counseling with 55% spending <5 minutes and 45% spending 5–10 minutes doing so. Almost all (95%) counseled on measuring and dosing, 84% on storage and use, 63% on potential side effects and when to contact a provider, 60% on the medication’s purpose (Figure 2). Few provided counseling on medication expiration (32%), when to expect results (26%), and the importance of medication adherence and missed doses (26%). Only 40% of pharmacies advised patients to avoid drinking and eating (NPO) after use. Patients were instructed to remain NPO for mean 34.4 minutes (SD 12.4).

Figure 2.

Pharmacy education and counseling for budesonide suspension

Cost varied between pharmacies with mean 30-day supply of $75.40 (SD $57.50) and greater cost with using proprietary suspension media such as Mucolox (Figure 1). Nearly half of pharmacies (40%) reported that the prescription was sometimes covered by insurance. If an FDA-approved EoE treatment became available, 45% of pharmacies would be willing to continue compounding budesonide for EoE.

DISCUSSION

With the lack of FDA-approved medications for EoE and the expense of off-label topical steroids, compounded formulations may be used. We found that few pharmacies in Michigan compound budesonide for EoE, especially in rural areas, and there is wide variation in the formulation and directed use. We describe heterogeneous practices in providing counseling to EoE patients, with less frequent emphasis on medication adherence. On average, the cost of compounded budesonide was one-tenth the cost compared to off-label use and almost half of pharmacies reported willingness to offer it even if an FDA-approved medication were to become available.

Our findings have implications for both patients and providers. For patients, variations in formulations may result in differences in drug efficacy and treatment responses, adherence to therapy, and ultimately disease control. As uninsured costs for uncovered medications may limit patient access, compounding offers an affordable treatment option. Our findings revealed that less than one-third of compounding practices offered budesonide suspension for EoE and many providers may not be aware of this specialty resource, particularly as all pharmacies in the state provide compounded budesonide for only 65 patients combined. Our findings on providing education and medication instructions highlight an area of need to optimize compliance and treatment response in EoE.

To our knowledge, this is the first study to examine compound pharmacy practices around budesonide suspension for EoE, but there are limitations to acknowledge. Our findings may not reflect practices in other states outside of Michigan or countries where access to therapies and financial costs vary. We were unable to accurately measure pharmacy costs, which could influence the cost charged to the patient. As a survey of pharmacies and their practices, our data does not include patient health information or explore outcomes such as efficacy, medication tolerance, or perceptions on education received.

We describe significant variations in compounding pharmacy practices for EoE budesonide suspension formulas, costs, availability, and patient education. As chronic maintenance therapy is required for disease control in EoE, our findings highlight the need for an affordable, accessible, standardized, and efficacious treatment for EoE.