Lindy Forte, MSc VALORE Research, Toronto, Canada Economic Evaluation of Loteprednol Etabonate versus Prednisolone in the Treatment of Ocular Inflammation Lindy Forte, MSc VALORE Research, Toronto, Canada Disclosure: The author has received research funding and travel expense reimbursement from Bausch and Lomb

Introduction Topical corticosteroids have been the standard of care in the treatment of ocular inflammation. Side effects of topical corticosteroids include: increased intraocular pressure (IOP), risk of cataract formation with long term use, and decreased resistance to infection. Loteprednol etabonate is a unique corticosteroid: quickly metabolized to inactive metabolites less propensity to cause IOP increase provides ocular specificity and minimal systemic absorption

Study Purpose To determine the cost-effectiveness of loteprednol etabonate relative to other commonly used steroids in the management of ocular inflammation.

Methods MEDLINE search for studies reporting results of randomized controlled clinical trials: loteprednol etabonate versus corticosteroid comparators, conducted in patients having either post-operative inflammation, acute anterior uveitis, giant papillary conjunctivitis, or seasonal allergic conjunctivitis. Data extraction: rates of anti-inflammatory efficacy, proportions of patients with clinically significant intraocular pressure (IOP) elevation. Perspective: Healthcare system

Methods (con’t) Resource Use and Costing: resources utilized to manage ocular inflammation and IOP elevation obtained from a panel of five ophthalmologists, resource costs were collected from the panel and from the U.S. Dept of Veteran’s Affairs formulary.

Results Included Studies Two of 51 publications met the inclusion criteria Excluded papers: not RCTS or lacked active corticosteroid comparator off-label uses duplicate publications Novack et al. reported results of a pooled analysis of RCTs (n=1648) mixed group of patients (n=1648) treated with loteprednol etabonate (0.2% or 0.5%) or prednisolone acetate 1% for 28 days or longer. Bartlett et al. reported results of a single RCT Patients (n=19) with a history of corticosteroid responsiveness treated with loteprednol etabonate 0.5% or prednisolone acetate 1%.

Results (con’t) Efficacy Differences between loteprednol etabonate and prednisolone acetate in control of inflammation were not reported Incidence of clinically significant IOP elevation* *pooled indication study: IOP ≥ 10 mm Hg; known steroid responder study: IOP > 15 mm Hg

Results (con’t) Mixed indication study Loteprednol saved an average of $8.24 per patient

Results (con’t) Known steroid responders study Loteprednol saved an average of $65.43 per patient

Conclusions Mixed indication Incidence of clinically significant IOP elevation: Loteprednol 1.7% Prednisolone 6.7% Loteprednol saved $8.24 per patient Known steroid responders Loteprednol 7.1% Prednisolone 30.8% Loteprednol saved $65.43 per patient

Discussion Health system perspective showed that the lower acquisition cost of prednisolone acetate was completely offset by the resources required to manage IOP elevation. Analysis was somewhat conservative as the potential for IOP elevation to go undetected with serious consequences was not considered. Results will depend upon local practice patterns and drug costs.