Economic Evaluation of Economic Evaluation of Loteprednol Etabonate versus Loteprednol Etabonate versus

Prednisolone in the Treatment of Prednisolone in the Treatment of Ocular InflammationOcular Inflammation

Lindy Forte, MScVALORE Research,

Toronto, Canada

Disclosure: The author has received research funding and travel expense reimbursement from Bausch and Lomb

IntroductionIntroduction 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 PurposeStudy Purpose

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

MethodsMethods 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)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.

ResultsResults

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)Results (con’t)Efficacy Differences between loteprednol etabonate and

prednisolone acetate in control of inflammation were not reported

Incidence of clinically significant IOP elevation*

0%

5%

10%

15%

20%

25%

30%

35%

PooledIndications

KnownSteroid

Responders

Loteprednol 0.5%

Prednisolone 1%

*pooled indication study: IOP ≥ 10 mm Hg; known steroid responder study: IOP > 15 mm Hg

Results (con’t)Results (con’t) Mixed indication study

Loteprednol saved an average of $8.24 per patient

Results (con’t)Results (con’t) Known steroid responders study

Loteprednol saved an average of $65.43 per patient

ConclusionsConclusions

Mixed indication Incidence of clinically significant IOP elevation:

Loteprednol 1.7% Prednisolone 6.7% Loteprednol saved $8.24 per patient

Known steroid responders Incidence of clinically significant IOP elevation:

Loteprednol 7.1% Prednisolone 30.8% Loteprednol saved $65.43 per patient

DiscussionDiscussion 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.