Elizabeth A Sugar1, Janet T Holbrook2, John H Kempen3, Alyce E Burke2, Lea T Drye2, Jennifer E Thorne4, Thomas A Louis5, Douglas A Jabs6, Michael M Altaweel7, Kevin D Frick8. 1. Department of Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Department Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Center for Clinical Trials, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Division of Biostatistics and Bioinformatics, The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: esugar2@jhu.edu. 2. Department Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Center for Clinical Trials, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland. 3. Ocular Inflammation Service, Department of Ophthalmology/Scheie Eye Institute, The University of Pennsylvania, Philadelphia, Pennsylvania; Center for Preventive Ophthalmology and Biostatistics, Department of Ophthalmology/Scheie Eye Institute, The University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, The University of Pennsylvania, Philadelphia, Pennsylvania. 4. Department Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Department of Ophthalmology, The Johns Hopkins University School of Medicine, Baltimore, Maryland. 5. Department of Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland. 6. Department Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Department of Ophthalmology, The Icahn School of Medicine at Mount Sinai, New York, New York; Department of Medicine, The Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: douglas.jabs@mssm.edu. 7. Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin. 8. The Johns Hopkins University Carey Business School, Baltimore, Maryland.
Abstract
OBJECTIVE: To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and panuveitis. DESIGN: Randomized, controlled, clinical trial. PARTICIPANTS: Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial. METHODS: Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant. MAIN OUTCOME MEASURES: The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up. RESULTS: The ICER at 3 years was $297,800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [Δ]: $16,900; P < 0.001) and the modest gains in QALYs (Δ = 0.057; P = 0.22). The probability of the ICER being cost-effective at thresholds of $50,000/QALY and $100,000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41,200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (Δ = $5300; P = 0.44) and a larger benefit in QALYs with the implant (Δ = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50,000/QALY and $100,000/QALY was 0.53 and 0.74, respectively. CONCLUSIONS:Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.
RCT Entities:
OBJECTIVE: To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and panuveitis. DESIGN: Randomized, controlled, clinical trial. PARTICIPANTS: Patients with active or recently active intermediate, posterior, or panuveitis enrolled in the Multicenter UveitisSteroid Treatment Trial. METHODS: Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant. MAIN OUTCOME MEASURES: The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up. RESULTS: The ICER at 3 years was $297,800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [Δ]: $16,900; P < 0.001) and the modest gains in QALYs (Δ = 0.057; P = 0.22). The probability of the ICER being cost-effective at thresholds of $50,000/QALY and $100,000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41,200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (Δ = $5300; P = 0.44) and a larger benefit in QALYs with the implant (Δ = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50,000/QALY and $100,000/QALY was 0.53 and 0.74, respectively. CONCLUSIONS:Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.
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Authors: Glenn J Jaffe; Daniel Martin; David Callanan; P Andrew Pearson; Brian Levy; Timothy Comstock Journal: Ophthalmology Date: 2006-05-09 Impact factor: 12.079
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Authors: John H Kempen; Michael M Altaweel; Lea T Drye; Janet T Holbrook; Douglas A Jabs; Elizabeth A Sugar; Jennifer E Thorne Journal: Ophthalmology Date: 2015-08-20 Impact factor: 12.079
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Authors: Elizabeth A Sugar; Alyce E Burke; Vidya Venugopal; Jennifer E Thorne; Janet T Holbrook Journal: Ophthalmology Date: 2020-07-24 Impact factor: 14.277
Authors: Samera Dean; Jonathan M Mathers; Melanie Calvert; Derek G Kyte; Dolores Conroy; Annie Folkard; Sue Southworth; Philip I Murray; Alastair K Denniston Journal: Br J Ophthalmol Date: 2017-04-28 Impact factor: 4.638