Cost Analysis of Aflibercept 8 mg Versus Aflibercept 2 mg for the Treatment of Diabetic Macular Edema in the PHOTON Trial

Abstract

Purpose:

To compare the direct and indirect costs of aflibercept 8 mg with aflibercept 2 mg in patients with diabetic macular edema (DME) using the published data from the PHOTON trial.

Methods:

Three groups of patients with DME were compared: 163 patients under a protocol of aflibercept 2 mg every 8 weeks, 328 patients under a protocol of aflibercept 8 mg every 12 weeks, and 167 patients under a protocol of aflibercept 8 mg every 16 weeks. A model-based comparative analysis was conducted using estimates of direct and indirect costs based on the mean number of injection visits and mean number of injections administered at the end of 96 weeks in the PHOTON aflibercept 8 mg clinical trial. The costs were adjusted for inflation to 2025 US dollars.

Results:

Using point estimates of real-world data, patients in the aflibercept 8 mg every 16 weeks group had the lowest overall total costs (mean $32,259.54), followed by those in the aflibercept 8 mg every 12 weeks group (mean $37,550.14). Patients in the aflibercept 2 mg every 8 weeks group had the highest total costs (mean $41,124.26). Cost differences were primarily driven by the higher number of injection visits in the 2 mg every 8 weeks regimen compared with the higher-dose, extended-interval 8 mg schedules at 96 weeks. Multi-way deterministic sensitivity analysis showed that the aflibercept 8 mg every 16 weeks regimen was the least costly option across all 10 000 Monte Carlo cost simulations.

Conclusions:

Across both deterministic and simulated analyses, aflibercept 8 mg at extended dosing intervals (every 12 or 16 weeks) resulted in statistically significant cost savings compared with the standard 2 mg every 8 weeks regimen.

Keywords

cost-analysis aflibercept diabetic macular edema

Introduction

Diabetic macular edema (DME) is a frequent cause of vision loss among individuals with diabetes and remains a major contributor to visual impairment worldwide.^1,2 With the growing prevalence of diabetes mellitus in the United States, the burden of disease continues to rise, contributing to increased healthcare costs, resource utilization, loss of productivity, and diminished quality of life.^3,4 These factors highlight the need for efficient and cost-eff treatment strategies.

Vascular endothelial growth factor (VEGF) is an important driver in the pathogenesis of DME.⁵ Intravitreal injections of anti-VEGF have become the standard of care, with studies supporting their ability to reduce DME and stabilize vision.^6,7 However, the frequent dosing regimens impose a significant burden on patients, often leading to nonadherence, undertreatment, and poor real-world outcomes.⁸ In fact, there are significant economic and societal implications of the current treatment regimen for DME. Beyond direct medical costs of treatment and monitoring, there are additional indirect costs that must be accounted for, such as caregiver burden, transportation, and patients’ lost wages and productivity. As the prevalence of DME continues to rise globally, the need for an effective, practical, and sustainable treatment is crucial.^9,10 One potential strategy to address this challenge is the use of higher-dose, extended-interval regimens, designed with the intent of extending the durability of VEGF suppression, thereby reducing the need for frequent injections.⁷

Aflibercept is an anti-VEGF agent frequently used in patients with DME at the standard 2 mg dose.¹¹ Recently, several clinical trials have examined whether higher-dosage formulations could provide noninferior therapeutic benefit.^7,12 The PHOTON trial, a phase 2/3 randomized, noninferiority clinical trial, evaluated the efficacy and safety of aflibercept 8 mg at extended dosing intervals compared with the 2 mg dosage in patients with DME. Patients who received aflibercept 8 mg demonstrated similar visual and anatomic outcomes and best-corrected visual acuity gains compared with the 2 mg group. Although the PHOTON study demonstrated the efficacy and safety of aflibercept 8 mg at extended dosing intervals, it is also important to assess its cost in comparison with that of 2 mg aflibercept across healthcare, patient, and societal perspectives.

This study assessed the cost-effectiveness of aflibercept 8 mg in patients with DME using data from the PHOTON trial. Specifically, we aimed to determine whether the increased dosage conferred economic benefits as compared with the 2 mg dosage, primarily through extended dosing intervals, despite the greater per-injection cost. The intent of this analysis is to support informed treatment and reimbursement decisions.

Methods

Model

We conducted a cost analysis using a theoretical model. The comparative analysis was performed using estimates of direct and indirect costs based on the number of injections administered at 96 weeks in the PHOTON aflibercept 8 mg clinical trial in patients with DME (ClinicalTrials.gov: NCT04429503). The population comprised 658 patients with a mean age of 62.3 years (range, 24–90 years) who were either treatment-naive at baseline (56%) or previously treated for DME involving the center of the macula (44%). Patients were randomized to receive treatment with aflibercept in 1 of 3 groups: a protocol of intravitreal aflibercept 2 mg every 8 weeks (n = 163), a protocol of intravitreal aflibercept 8 mg every 12 weeks (n = 328), or a protocol of intravitreal aflibercept 8 mg every 16 weeks (n = 167), following initial monthly dosing. From week 16, dosing intervals for the aflibercept 8 mg groups were shortened if patients met prespecified dose-regimen modification criteria denoting disease activity. Healthcare costs, including medical care and cost of patient and caregiver time, as well as cost of lost productivity were included in the analysis (Supplementary Tables 1 and 2).

Direct and Indirect Cost Estimates

Estimates of direct and indirect healthcare costs in the model were based on the number of visits and mean number of injections administered at 96 weeks in the aflibercept 8 mg clinical trial. The mean total number of injections over a 96-week period was 13.8 for the aflibercept 2 mg every 8 weeks group, 9.5 for the aflibercept 8 mg every 12 weeks group, and 7.8 for the aflibercept 8 mg every 16 weeks. Direct costs for treatment were calculated based on the mean number of visits over the study period as well as on the cost of evaluation and imaging identified using the corresponding Current Procedural Terminology (CPT) codes 99204 and 92012 from Medicare. We also included the wholesale acquisition costs of the medication and cost of the medical procedure for injection based on the corresponding CPT code 67028, if the injection was performed during the visit.

Indirect costs related to the patients’ and caregivers’ absence from work in order for the patient to receive treatment were calculated using multiple parameters. These societal costs included several parameters, which were extracted from the US Bureau of Labor Statistics: patient and caregiver time taken off from work for an appointment (US wage per working hour), a reduction in hourly wage for non-working people’s time, hours of lost patient productivity due to injection and appointment, percentage of caregivers’ time taken from activities, and percentage of patients who required a caregiver.^13,14 The average appointment time included wait time, workup, imaging, injection, and postinjection recovery time. The average distance in miles traveled to get to an appointment and the cost per mile travelled were also accounted for in the analysis. The costs were adjusted for inflation to 2025 US dollars.

Ethics Statement

The study was approved by the Institutional Review Board of Massachusetts Eye and Ear. The study adhered to the tenets of the Declaration of Helsinki as well as the recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine and the Consolidated Health Economic Evaluation Reporting Standards.¹⁵

Statistical Analysis

All statistical analyses were performed using Python (version 3.13.7) and the SciPy package (version 1.16.2). Multi-way sensitivity analysis was performed with first-order Monte Carlo simulations repeated 10 000 times for each patient treatment group (random seed set to 888 for reproducibility). For these simulations, we first defined a range of evaluation costs, imaging costs, and transportation costs (see Table 2). Because the true distribution of these costs is unknown, we assumed a uniform distribution of costs within these ranges. For each simulation run, we randomly sampled 1 value from each range, which we used to calculate total simulated cost for the simulated patients in each treatment arm. Drug costs and injection costs were held constant within each treatment arm for all 10 000 simulations.

Results

At 96 weeks, the cumulative costs of aflibercept treatment for a patient with DME varied significantly across treatment arms. After accounting for the mean number of injections received during the study period, patients in the aflibercept 8 mg every 16 weeks group had the lowest direct costs (mean $28,534.54) as compared with patients in the aflibercept 8 mg every 12 weeks group (mean $33,858.50) and patients in the aflibercept 2 mg every 8 weeks group (mean $37,493.85). Patients treated in the 8 mg every 16 weeks group had the lowest overall total costs (mean $32,259.54), followed by those in the 8 mg every 12 weeks group (mean $37,550.14). Patients in the 2 mg every 8 weeks group had the highest total costs (mean $41,124.26) (Table 1).

Table 1.

Total Costs at End of 96 Weeks Calculated for each Aflibercept Dose Group of Patients With Diabetic Macular Edema in the PHOTON Trial.^a

Aflibercept Dose and Schedule^b	Mean Cost Per Dose, $	Mean No. of Injection Visits	Mean No. of Monitoring Visits	Mean Cost of Injection Visits, $	Mean Cost of Monitoring Visits, $	Mean Total Costs, $
2q8	1,942.33	13.8	10	$2,758.97	$305.04	$41,124.26
8q12	2,625.00	9.5	15	$3,471.00	$305.04	$37,550.14
8q16	2,625.00	7.8	17	$3,471.00	$305.04	$32,259.54

Costs were adjusted for inflation to 2025 US dollars.

Patients were randomized to receive aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), or aflibercept 8 mg every 16 weeks (8q16).

To account for uncertainty in evaluation costs, imaging costs, and transportation costs, 10 000 Monte Carlo simulations were performed for each treatment arm. Each simulation calculated the total costs and direct costs at 96 weeks for a patient using a given dose in a scheduled group, with randomly generated evaluation cost, imaging cost, and transportation cost sampled from uniform distribution between estimated minimum and maximum costs for each category (Table 2).

Table 2.

Multi-Way Deterministic Sensitivity Analysis of Direct and Total Costs at 96 Weeks Generated on 10 000 Monte Carlo Simulations for Each Aflibercept Dose Group of Patients With Diabetic Macular Edema.^a

	Simulated Cost Estimate, $
Aflibercept Dose and Schedule^b	Mean	95% CI	Simulations Least Costly, %
Direct costs
2q8	40,626.31	39,690.80 to 41,548.69	0
8q12	35,522.31	34,586.80 to 36,444.69	0
8q16	29,208.56	28,273.05 to 30,130.94	100
Total costs
2q8	44,468.86	43,357.31 to 45,571.79	0
8q12	39,319.47	38,207.92 to 40,422.40	0
8q16	32,987.56	31,876.02 to 34,090.50	100

Costs were adjusted for inflation to 2025 US dollars, with simulations using a randomly generated evaluation cost range (minimum–maximum, $85.39–$163.35), imaging cost range (minimum–maximum, $31.38–$35.58), and transportation cost range (minimum–maximum, $13.32–$46.30).

Patients were randomized to receive aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), or aflibercept 8 mg every 16 weeks (8q16).

The mean total costs generated by our simulations were highly similar to the deterministic estimates, with narrow 95% CIs (Table 2). We also performed simulations to calculate direct costs only, which closely mirrored the results generated on total cost simulations (Table 2). Across all 10 000 simulations, the aflibercept 8 mg every 16 weeks group was found to have the lowest total cost and the lowest direct cost of all treatment arms (Figure 1).

Conclusions

In this model-based cost analysis, we assessed the economic value of extended-interval aflibercept injections for the management of DME. The PHOTON trial demonstrated that noninferior visual acuity outcomes were achieved with intravitreal aflibercept 8 mg compared with the standard 2 mg regimen, while both the initial number and total number of injections were substantially reduced.⁷ Building on this, we examined the patient-level economic implications of adopting the extended dosing strategy. We found that aflibercept 8 mg administered at prolonged dosing intervals was associated with significant direct and overall cost savings relative to the standard 2 mg treatment protocol, despite a higher per-unit cost.

Among the 3 evaluated regimens, aflibercept 8 mg every 16 weeks had the lowest overall total cost (mean, $32,259.54), comprising direct and indirect expenses related to the patient and caregiver over 96 weeks, followed by the aflibercept 8 mg every 12 weeks group (mean total cost, $37,550.14), while the aflibercept 2 mg every 8 weeks group incurred the highest total costs (mean, $41,124.26). Differences were primarily driven by the higher number of injections in the 2 mg every 8 weeks regimen compared with the extended-interval 8 mg dosing schedules. These findings were also consistent when only direct costs were considered and across both simulations, indicating that reduced treatment frequency, although with a more expensive medication, significantly lowers the economic burden for patients and the healthcare system. Although the per-dose acquisition cost of aflibercept 8 mg ($2,625.00) is higher than that of aflibercept 2 mg ($1,942.33), the extended dosing intervals make the higher-dose regimen more cost-effective pertaining to direct medical costs as it translates into fewer clinical visits and use of healthcare resources. These results highlight the overall economic advantage of aflibercept 8 mg, both in the every 16- and every 12- week regimens.

DME is now considered a chronic condition that requires frequent intravitreal anti-VEGF injections and regular follow-up visits, which can impose a financial and logistical burden on the patient and their caregivers. The requirement for ongoing, often monthly, treatment and monitoring has been cited as a major factor contributing to nonadherence and loss to follow-up, with reported rates ranging from 12% to 61% in DME populations.^16,17 To optimize patient adherence and resource allocation, it is necessary to adopt treatment strategies that benefit patients holistically. Increasing the dose of intravitreal aflibercept is an alternative approach that can increase the durability of DME control.¹⁸ In order to comprehensively capture the societal impact of DME treatment, we included both direct and indirect costs in our analysis. The burden of treatment visits extends beyond clinic-based expenses to include patient and caregiver time, transportation, and lost wages. These indirect costs represent a significant yet often overlooked component of the overall economic impact of DME management. By extending treatment intervals, aflibercept 8 mg can reduce these societal and logistical costs, improving both patient adherence and satisfaction while maintaining disease control.

It is important to note that the results of the current study are derived from data over a 96-week period, as reported in the PHOTON trial. While the current results offer strong mid-term data, the long-term economic benefit of extended-interval aflibercept 8 mg could be even more favorable. In the PHOTON study, there are loading doses that increase the number of doses in the first year. The cost-benefit associated with aflibercept 8 mg would likely translate into a greater cumulative cost savings and potentially improved quality of life over a patient’s lifetime, as long as the extended durability can be maintained. However, it must be noted that the number of injections required for DME has been shown to decrease over time,^19,20 and further long-term studies are required to assess outcomes and need for long-term treatment with either aflibercept 8 mg or aflibercept 2 mg.

Our results are consistent with previous pharmacoeconomic analyses in patients with DME, which have demonstrated that the cost of medication is often the greatest factor. Reducing injection frequency is therefore the best strategy to decrease overall costs.^21,22 Previous studies have compared aflibercept with alternative therapies and reported that bevacizumab, particularly in a bevacizumab-first approach as studied in Protocol AC, may be less costly for patients with DME over a 2-year period, with direct costs of $29,000 for the bevacizumab first group and $42,000 for the aflibercept first group.^23,24 However, when broader societal and direct medical costs were considered, the overall expenses associated with the bevacizumab-first strategy in Protocol AC exceeded those observed with aflibercept real-world treatment patterns. This was driven by the high incidence of treatment failure with bevacizumab (70%). The direct costs with aflibercept 8 mg in the every 16 weeks treatment arm were similar to a bevacizumab first approach, suggesting limited utility for step therapy if visual outcomes are equivalent and extended dosing can be maintained. Moreover, aflibercept generally carries less supply chain volatility than bevacizumab, as it is US Food and Drug Administration–approved for ophthalmic use and supplied in standardized, single-use intravitreal vials. In contrast, bevacizumab requires repackaging by compounding pharmacies, introducing additional regulatory, sterility, and distribution vulnerabilities that can lead to intermittent shortages or delays in availability.^25,26 Future head-to-head comparisons of cost-effectiveness between aflibercept 8 mg and other intravitreal agents for DME are warranted to provide more comprehensive insights on long-term clinical value.

The implications of our findings extend beyond DME and can be broadly applied to different retinal pathologies. Aflibercept 8 mg has been approved for other retinal indications, including neovascular age-related macular degeneration and retinal vein occlusion, for which long-term treatment burden remains a challenge. As more data from real-world studies become available in these different indications, further cost-effectiveness analysis would be valuable to assess the applicability and rentability of new high-dose, extended-interval treatment approaches. Additionally, there are other medications that have been shown to improve durability (eg, faricimab), and real-world studies would be required to compare their relative efficacy and cost-effectiveness against aflibercept 8 mg.

There are some limitations to this study. First, the analysis was based on injection frequencies and outcomes reported in a controlled trial environment, which may differ from real-world treatment patterns. Real-world studies show greater variability in adherence, response, and frequency of the visits, which may influence the cost-effectiveness of aflibercept 8 mg. Regional practice patterns, patient-level considerations, and individual provider preferences may exert substantial impact on the ultimate cost distribution of these different therapies. For this study, we used Medicare reimbursement values to calculate intravitreal injection cost, but alternative payors will produce varying costs for the same injection, a reality that is not captured in our analysis.

Regarding technical limitations to our analysis, because the true distribution of each cost used in our calculations is unknown, we employed random sampling from a uniform distribution within estimated ranges for each of the cost parameters in our Monte Carlo simulation. This limits the generalizability of our findings as our Monte Carlo simulations using estimated costs likely fail to capture the true distribution of real-world costs. However, the deterministic sensitivity analysis that we present provides a valuable first cost comparison that can guide future, granular studies of these different regimens.

In conclusion, this cost analysis demonstrated that aflibercept 8 mg administered every 12 or 16 weeks in patients with DME in the PHOTON trial may provide direct and indirect cost savings compared with the standard aflibercept 2 mg given every 8 weeks, despite a higher per-unit cost. By effectively maintaining visual outcomes with fewer injections and visits, aflibercept 8 mg can enhance a patient- and caregiver-centric treatment strategy for DME.

Supplemental Material

sj-docx-1-vrd-10.1177_24741264261469696 – Supplemental material for Cost Analysis of Aflibercept 8 mg Versus Aflibercept 2 mg for the Treatment of Diabetic Macular Edema in the PHOTON Trial

Supplemental material, sj-docx-1-vrd-10.1177_24741264261469696 for Cost Analysis of Aflibercept 8 mg Versus Aflibercept 2 mg for the Treatment of Diabetic Macular Edema in the PHOTON Trial by Celine Chaaya, Stephanie Zhang, Samantha E. Hoffman, Anshul Bhatnagar, Sandra Hoyek, Ryan Sameen Meshkin, Nicolas A. Yannuzzi, Hasenin Al-Khersan and Nimesh A. Patel in Journal of VitreoRetinal Diseases

Footnotes

ORCID iDs

Celine Chaaya

Ryan Sameen Meshkin

Hasenin Al-Khersan

Nimesh A. Patel

Ethical Considerations

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Regeneron as a collaborative study without input on study design, results, or writing. Dr. Patel’s work is supported by the Retina Innovation Fund, Massachusetts Eye and Ear (Boston, MA), the Simouran Family Foundation, and the Saint Vincent de Paul Foundation. The funding organizations had no role in the design or conduct of this research.

Declaration of Conflicting Interests

The following authors declared potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Patel is a consultant to Alcon, Alimera, Allergan, Apellis, Atheneum, Biogen, DORC, EyePoint, Genentech, Gerson Lehrman Group, Inc., Guidepoint, Lifesciences, Regenx Bio, and Regeneron. Dr. Al-Khersan is a consultant to AbbVie, Adverum, ANI, Apellis, EyePoint, Genentech, and Regeneron. None of the other authors declared potential conflicts of interest with respect to the research, authorship, and/or publication of the article.

Supplemental Material

Supplemental material is available online with this article.

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