Intravitreal Aflibercept Versus Ranibizumab for Wet Age-Related Macular Degeneration: A Cost-Effectiveness Analysis

Hernández, Luis; Lanitis, Tereza; Cele, C; Toro-Díaz, Hector; Gibson, Andrea; Kuznik, Andreas

doi:10.18553/jmcp.2018.24.7.608

Cited by 21 publications

(18 citation statements)

References 42 publications

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“…One study using a similar Markov structure with on-treatment and off-treatment health states, and substates based on BCVA found that aflibercept was cost-effective compared with ranibizumab for the treatment of wet AMD. 51 The findings of this study are consistent with earlier analyses showing similar QALY gains with aflibercept and ranibizumab, with lower costs for aflibercept compared with ranibizumab.…”

Section: Discussionsupporting

confidence: 91%

Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis

Carlton²,

Agashivala

et al. 2021

JMCP

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BACKGROUND: Age-related macular degeneration (AMD) is a leading cause of blindness worldwide and is the most common cause of blindness in developed countries. Despite antivascular endothelial growth factor (anti-VEGF) therapy demonstrating improvements in visual and anatomical outcomes, unmet needs remain. Brolucizumab-dbll (ie, brolucizumab), a VEGF inhibitor for treatment of neovascular (wet) AMD and recently approved by the FDA for its treatment of wet AMD, attempts to mitigate treatment burden through less frequent injections. OBJECTIVE: To assess the incremental costeffectiveness of brolucizumab compared with aflibercept and ranibizumab, given similar costs per injection and the potential for longer dosing intervals based on phase 3 clinical trial data. METHODS: A Markov model was developed to model the treatment of wet AMD patients with brolucizumab vs aflibercept and vs ranibizumab over a lifetime time horizon (base case) and 5-year time horizon (scenario analysis). The Markov model consisted of 3 primary health states: on treatment, off treatment, and death. Markov substates (5 total) described visual acuity (VA) ranging from no vision impairment to blindness. These VA-based substates were defined by best-corrected visual acuity (BCVA) values measured using Early Treatment Diabetic Retinopathy Study letters. Fixed-dosing regimens for each therapy were included in the model: dosing every 4 weeks (q4w) for the first 3 months followed by dosing q8w/q12w

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Section: Discussionsupporting

confidence: 91%

Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis

Carlton²,

Agashivala

et al. 2021

JMCP

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“…ADVM-022 gene therapy has been designed to address the challenges associated with the current standard of care for nAMD, notably the repeated IVT injections for the lifetime of the patient required to maintain visual function, 30 , 31 by providing a continuous supply of an approved anti-VEGFA protein to the eye after a single IVT delivery.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Aflibercept Expression in NHPs following Intravitreal Administration of ADVM-022, a Potential Gene Therapy for nAMD

Kiss

Grishanin²,

Nguyen³

et al. 2020

Molecular Therapy - Methods & Clinical Development

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Several standard-of-care therapies for the treatment of retinal disease, including aflibercept, inhibit vascular endothelial growth factor (VEGFA). The main shortcoming of these therapies is potential undertreatment due to a lack of compliance resulting from the need for repeated injections. Gene therapy may provide sustained levels of anti-VEGFA proteins in the retina following a single injection. In this nonhuman primate study, we explored whether ADVM-022, a recombinant adeno-associated virus (AAV) vector designed to express aflibercept, could induce anti-VEGFA protein levels comparable with those observed following a single-bolus intravitreal (IVT) injection of the standard-of-care aflibercept recombinant protein. The results demonstrated that intraocular levels of aflibercept measured at 56 days after a single IVT injection of ADVM-022 were equivalent to those in the aflibercept recombinant protein-injected animals measured 21–32 days post-administration. ADVM-022-injected animals exhibited signs of an initial self-limiting inflammatory response, but overall all doses were well tolerated. ADVM-022 administration did not result in systemic exposure to aflibercept at any dose evaluated. These results demonstrated that a single IVT injection of ADVM-022 resulted in safe and efficacious aflibercept levels in the therapeutic range, suggesting the potential of a gene therapy approach for long-term treatment of retinal disease with anti-VEGF therapy.

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“…Per-dose cost is approximately US $772.94 per syringe, per pill, or unit, for pegaptanib; US $1216.65 per syringe, per pill, or unit for ranibizumab; US $1920.04 per vial, per pill, or unit, for aflibercept; and US $50 for bevacizumab. 60–62 According to the model developed by Kuopio University Hospital, 63 the direct medical costs include: (a) the costs of diagnosis including medical visit, FA, and OCT; (b) the cost of intravitreal injection of the medication; (c) the costs of follow up, including a medical visit and OCT; and (d) rehabilitation of legally blind persons. For one patient, a 6-week regimen with pegaptanib costs US $7729.40 per year, while bevacizumab PRN costs US $1610.40, ranibizumab PRN costs US $16,687.70, bevacizumab monthly costs US $2924.60, ranibizumab monthly US $25,759.20, aflibercept monthly costs US $13,954.70, aflibercept bimonthly costs US $6977.3, bevacizumab treat-and-extend regimen costs US $2167.9, ranibizumab treat-and-extend regimen costs US $18,678.9, and afliber-cept treat-and-extend regimen costs US $11,280.1.…”

Section: Discussionmentioning

confidence: 99%

Comparative efficacy and safety of anti-vascular endothelial growth factor regimens for neovascular age-related macular degeneration: systematic review and Bayesian network meta-analysis

Zhao

Wang

et al. 2020

Therapeutic Advances in Chronic Disease

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Background: As a debilitating neurodegenerative disease, neovascular age-related macular degeneration (nAMD) accounts for more than 90% of severe visual loss or legal blindness among AMD patients. Anti-vascular endothelial growth factor (VEGF) had been applied widely in nAMD treatment. To date, debate regarding efficacy and safety still exists among different anti-VEGF regimens as management of nAMD. To provide substantial evidence for clinical nAMD treatment, this study ranks the priority of anti-VEGF regimens via Bayesian network meta-analysis (NMA), comparing data collected from randomized controlled trials (RCTs). Methods: We searched PubMed Central, MEDLINE Ovid, Embase Ovid, ISRCTN, ICTRP and ClinicalTrials. gov from a database established until 1 April 2019 systematically for anti-VEGF regimens. Bayesian NMA with random-effect was conducted to compare efficacy and safety and rank priority of anti-VEGF regimens. The primary efficacy and safety outcomes were the proportion of patients gaining 15 or more letters, and the incidence of arterial thromboembolic (ATC) events. The effect measure is the standard mean difference (SMD), or the odds ratio (OR) with their 95% confidence interval (CI). The study protocol is registered with PROSPERO, number CRD42019132243. Results: We obtained 6467 citations and identified 29 RCTs including 13,596 participants; 86% of these trials were low risk or of uncertain risk bias. In NMA, ORs compared with sham injection for the proportion of patients gaining 15 or more letters (12,699 participants from 23 trials) ranged from 4.05 [95% Bayesian credible interval (CrI) 1.62–10.11] for ranibizumab quarterly regimen to 8.57 (95% CrI 4.66–15.73) for a ranibizumab treat-and-extend regimen. No difference was found between sham injection and anti-VEGF regimens for ATC events (11,500 participants from 18 trials). Results for the primary outcome did not substantially change in sensitivity analyses after removing studies at high risk of bias and small sample size ( n < 100), respectively. Conclusion: The treat-and-extend regimen of ranibizumab and aflibercept are the preferred anti-VEGF regimens for nAMD. Bevacizumab treat-and-extend regimens need more head-to-head comparisons with other regimens or sham injection for advanced application. The treat-and-extend regimen proved to be the most effective regimen for each anti-VEGF drug in the NMA. Pegaptanib every 6 weeks and Conbercept quarterly are unable to satisfy the best corrected visual acuity (BCVA) improvement requirement of nAMD patients.

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Intravitreal Aflibercept Versus Ranibizumab for Wet Age-Related Macular Degeneration: A Cost-Effectiveness Analysis

Cited by 21 publications

References 42 publications

Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis

Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis

Analysis of Aflibercept Expression in NHPs following Intravitreal Administration of ADVM-022, a Potential Gene Therapy for nAMD

Comparative efficacy and safety of anti-vascular endothelial growth factor regimens for neovascular age-related macular degeneration: systematic review and Bayesian network meta-analysis

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