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Cost analysis comparing adjuvant epimacular brachytherapy with anti-VEGF monotherapy for the management of neovascular age-related macular degeneration.

ABSTRACT: AIMS:To consider the cost implication of adopting epimacular brachytherapy (EMB) for the treatment of neovascular (wet) age-related macular degeneration (wAMD), compared with ranibizumab or bevacizumab monotherapy. METHODS:This analysis compared the cumulative 3-year costs of anti-VEGF (vascular endothelial growth factor) monotherapy to EMB combined with anti-VEGF therapy. Two patient groups were considered: newly diagnosed (treatment-naïve) patients; and patients already receiving chronic anti-VEGF therapy. RESULTS:In the treatment-naïve patients, the highest cumulative treatment costs were associated with ranibizumab monotherapy (£25,658), followed by bevacizumab monotherapy (£16,177), EMB with ranibizumab (£14,002), then EMB with bevacizumab (£10,289). In previously treated patients, the highest treatment costs were ranibizumab monotherapy (£18,355), followed by EMB with ranibizumab (£17,428), bevacizumab monotherapy (£16,177), then EMB with bevacizumab (£12,129). CONCLUSION:EMB combined with anti-VEGF treatment has the potential to yield considerable cost savings, compared with anti-VEGF monotherapy. If the ongoing large studies of EMB confirm the published feasibility data, then adjuvant EMB may represent a cost-effective alternative to anti-VEGF monotherapy.

SUBMITTER: Jackson TL

PROVIDER: S-EPMC3325571 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Cost analysis comparing adjuvant epimacular brachytherapy with anti-VEGF monotherapy for the management of neovascular age-related macular degeneration.

Jackson T L TL Kirkpatrick L L Tang G G Prasad S S

Eye (London, England) 20120120 4

<h4>Aims</h4>To consider the cost implication of adopting epimacular brachytherapy (EMB) for the treatment of neovascular (wet) age-related macular degeneration (wAMD), compared with ranibizumab or bevacizumab monotherapy.<h4>Methods</h4>This analysis compared the cumulative 3-year costs of anti-VEGF (vascular endothelial growth factor) monotherapy to EMB combined with anti-VEGF therapy. Two patient groups were considered: newly diagnosed (treatment-naïve) patients; and patients already receivin ...[more]

PMID: 22261737

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Project description:ImportanceAlthough anti-vascular endothelial growth factor (VEGF) treatment offers better outcomes than the natural history of neovascular age-related macular degeneration (ARMD), a less burdensome, less expensive, and more durable treatment is needed.ObjectiveTo assess the efficacy and safety of epimacular brachytherapy (EMB) for chronic, active, neovascular ARMD.Design, setting, and participantsThe Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis) Only Treatment (MERLOT) pivotal device trial was conducted at 24 National Health Service hospitals across the UK. Patients who had neovascular ARMD and received intravitreal ranibizumab were enrolled between November 10, 2009, and January 30, 2012. Eligible patients were randomized 2:1 and were stratified by lens status and angiographic lesion type to receive either EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy. Participants were followed up monthly for 24 months and then assessed at a final visit at month 36. Masking of participants and clinicians was not possible, but best-corrected visual acuity (BCVA) and imaging were analyzed by masked assessors. Analysis followed the intent-to-treat approach.InterventionsPars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab vs as-needed ranibizumab monotherapy.Main outcomes and measuresCoprimary outcomes were the number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters. Secondary outcomes were the percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters and the mean change in angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography.ResultsOf 363 participants, 329 (90.6%) completed 24 months of follow-up (222 participants in the EMB group and 107 in the ranibizumab group). The mean (SD) age of the combined groups was 76.5 (7.4) years. The mean (SD) number of ranibizumab injections was 9.3 (6.7) in the EMB group and 8.3 (4.5) in the ranibizumab group, with a difference of 1.0 injection (95% CI, -0.3 to 2.3; P = .13). The mean (SD) BCVA change was -11.2 (15.7) ETDRS letters in the EMB group and -1.4 (10.9) ETDRS letters in the ranibizumab group, with a difference of 9.8 ETDRS letters (95% CI, -6.7 to -12.9). In the EMB group, 65.6% of participants (160 of 244) lost fewer than 15 ETDRS letters vs 86.6% (103 of 119) in the ranibizumab group, with a difference of 21% (95% CI, 12.4%-29.5%; P < .001). Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group. These abnormalities occurred outside the foveal center, and there were no unexpected safety concerns.Conclusions and relevanceThe MERLOT trial found that despite the acceptable safety of EMB, it did not reduce the number of ranibizumab injections and was associated with worse visual acuity than anti-VEGF treatment alone; these results do not support EMB use as an adjunct treatment for chronic, active neovascular ARMD.Trial registrationClinicalTrials.gov Identifier: NCT01006538.

Project description:PurposeTo probabilistically forecast needed anti-vascular endothelial growth factor (anti-VEGF) treatment frequency using volumetric spectral domain-optical coherence tomography (SD-OCT) biomarkers in neovascular age-related macular degeneration from real-world settings.MethodsSD-OCT volume scans were segmented with a custom deep-learning-based analysis pipeline. Retinal thickness and reflectivity values were extracted for the central and the four inner Early Treatment Diabetic Retinopathy Study (ETDRS) subfields for six retinal layers (inner retina, outer nuclear layer, inner segments [IS], outer segments [OS], retinal pigment epithelium-drusen complex [RPEDC] and the choroid). Machine-learning models were probed to predict the anti-VEGF treatment frequency within the next 12 months. Probabilistic forecasting was performed using natural gradient boosting (NGBoost), which outputs a full probability distribution. The mean absolute error (MAE) between the predicted versus actual anti-VEGF treatment frequency was the primary outcome measure.ResultsIn a total of 138 visits of 99 eyes with neovascular AMD (96 patients) from two clinical centers, the prediction of future anti-VEGF treatment frequency was observed with an accuracy (MAE [95% confidence interval]) of 2.60 injections/year [2.25-2.96] (R2 = 0.390) using random forest regression and 2.66 injections/year [2.31-3.01] (R2 = 0.094) using NGBoost, respectively. Prediction intervals were well calibrated and reflected the true uncertainty of NGBoost-based predictions. Standard deviation of RPEDC-thickness in the central ETDRS-subfield constituted an important predictor across models.ConclusionsThe proposed, fully automated pipeline enables probabilistic forecasting of future anti-VEGF treatment frequency in real-world settings.Translational relevancePrediction of a probability distribution allows the physician to inspect the underlying uncertainty. Predictive uncertainty estimates are essential to highlight cases where human-inspection and/or reversion to a fallback alternative is warranted.

Project description:PurposeWe sought to determine the most cost-effective treatment for patients with newly diagnosed neovascular macular degeneration: monthly or as-needed bevacizumab injections, or monthly or as-needed ranibizumab injections.DesignCost-effectiveness analysis.ParticipantsHypothetical cohort of 80-year-old patients with newly diagnosed neovascular macular degeneration.MethodsUsing a mathematical model with a 20-year time horizon, we compared the incremental cost-effectiveness of treating a hypothetical cohort of 80-year-old patients with newly diagnosed neovascular macular degeneration using monthly bevacizumab, as-needed bevacizumab, monthly ranibizumab, or as-needed ranibizumab. Data came from the Comparison of Age-related macular degeneration Treatment Trial (CATT), the Medicare Fee Schedule, and the medical literature.Main outcome measuresCosts, quality-adjusted life-years (QALYs), and incremental costs per QALY gained.ResultsCompared with as-needed bevacizumab, the incremental cost-effectiveness ratio of monthly bevacizumab is $24,2 357/QALY. Monthly ranibizumab gains an additional 0.02 QALYs versus monthly bevacizumab at an incremental cost-effectiveness ratio of >$10 million/QALY. As-needed ranibizumab was dominated by monthly bevacizumab, meaning it was more costly and less effective. In sensitivity analyses assuming a willingness to pay of $100,000/QALY, the annual risk of serious vascular events would have to be ≥2.5 times higher with bevacizumab than that observed in the CATT trial for as-needed ranibizumab to have an incremental cost-effectiveness ratio of <$100,000/QALY. In another sensitivity analysis, even if every patient receiving bevacizumab experienced declining vision by 1 category (e.g., from 20/25-20/40 to 20/50-20/80) after 2 years but every patient receiving ranibizumab retained their vision level, as-needed ranibizumab would have an incremental cost-effectiveness ratio of $97,340/QALY.ConclusionsEven after considering the potential for differences in risks of serious adverse events and therapeutic effectiveness, bevacizumab confers considerably greater value than ranibizumab for the treatment of neovascular macular degeneration.

Dataset Information

Cost analysis comparing adjuvant epimacular brachytherapy with anti-VEGF monotherapy for the management of neovascular age-related macular degeneration.

Publications

Cost analysis comparing adjuvant epimacular brachytherapy with anti-VEGF monotherapy for the management of neovascular age-related macular degeneration.

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