Multidimensional Evaluation of the Potential Impact of Faricimab Availability on Healthcare System Accessibility for Retinal Disease Treatment in Poland

Multidimensional Evaluation of the Potential Impact of Faricimab Availability on Healthcare System Accessibility for Retinal Disease Treatment in Poland | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Multidimensional Evaluation of the Potential Impact of Faricimab Availability on Healthcare System Accessibility for Retinal Disease Treatment in Poland Michał Seweryn, Justyna Kopel, Joanna Augustynska, Adam Mikołajewicz, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7299149/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 23 Feb, 2026 Read the published version in BMC Health Services Research → Version 1 posted 12 You are reading this latest preprint version Abstract Background This study aimed to evaluate the impact of introducing faricimab into a publicly funded drug programme for retinal diseases, focusing particularly on reducing treatment frequency and optimising resources. Faricimab, a bispecific antibody targeting angiopoietin-2 and VEGF-A, offers a dual mechanism for managing nAMD and DME, both leading causes of vision loss. Methods The analysis included forecasting patient treatment trends, estimating the potential market share of faricimab, and simulating drug administration frequencies. A Monte Carlo simulation was conducted to model the impact of faricimab on reducing injection frequency. Scenarios with variable patient numbers and administration rates were explored, covering the years 2025, 2030, and 2035, to assess potential efficiencies in healthcare resources use and the capacity to treat additional patients. Results Results indicated that faricimab could reduce injection frequency by approximately 15%, freeing up resources within the healthcare system. Under the primary scenario, faricimab introduction could enable an additional 2,115 patients to be treated in 2025, rising to 7,662 by 2035 without additional resources. In the minimum scenario, the capacity increased by 4,920 patients by 2035, while the maximum scenario saw an increase of 10,885 patients. Conclusions The introduction of faricimab is expected to improve access to ophthalmic treatments, especially within the drug programme for retinal diseases, by decreasing injection frequency and enhancing resource efficiency. Given Poland’s ageing population and the rising prevalence of nAMD and DME, which represent significant public health challenges, faricimab adoption could alleviate pressures on healthcare infrastructure, ultimately supporting better patient outcomes and overcoming current limitations in access to ophthalmic services. Diabetic macular edema neovascular age-related macular degeneration decreasing injection frequency faricimab vascular endothelial growth factor-A Poland public health Figures Figure 1 Background Diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) are two common eye diseases that can cause severe visual impairment, and if left untreated, even irreversible blindness [ 1 , 2 ]. Elevated levels of angiopoietin-2 and vascular endothelial growth factor (VEGF) play a key role in their pathogenesis, causing excessive growth of fragile and unstable subretinal blood vessels [ 3 ]. Leakage from their walls leads to the accumulation of fluids in the intraretinal spaces, gradually leading to structural damage and deterioration of visual function. VEGF overexpression further stimulates local inflammatory processes, accelerating disease progression and vision loss [ 3 , 4 ]. Faricimab, the first and only medicine to reduce both vascular leakage and inflammation, is an innovative bispecific antibody that blocks both angiopoietin-2 and VEGF-A, registered by the European Medicines Agency (EMA) in 2022. This dual mechanism of disease control restores vascular stability in the eye more effectively than monospecific biologic therapies used previously, and the therapeutic effect lasts longer [ 5 ]. Faricimab’s efficacy in DME and nAMD has been demonstrated in four randomised phase III clinical trials, encompassing over 3,200 participants in over 30 countries [ 6 , 7 ]. The novel therapy showed non-inferiority to aflibercept at the specified primary endpoint in all of the trials: mean change in best-corrected visual acuity, averaged over weeks 48, 52, and 56 in YOSEMITE/RHINE studies and over weeks 40, 44, and 48 in TENAYA/LUCERNE studies [ 8 , 9 ]. Durable vision gains with faricimab were achieved with a treat-and-extend dosing regimen, which allowed for longer intervals compared to aflibercept (which is dosed every 8 weeks). In DME flexible dosing enabled approximately 50% of patients to be treated with faricimab at intervals of up to 16 weeks, and around 70% of patients at intervals of at least 12 weeks. Similarly, in nAMD 45% of patients were able to maintain dosing intervals of up to 16 weeks, whereas those receiving aflibercept followed a fixed dosing regimen every 8 weeks [ 9 ]. The results of the randomised clinical trials have been replicated in routine clinical practice, where faricimab has enabled an extension of treatment intervals in both previously treated and treatment-naïve patients. The expected efficacy of the medication was maintained in 60–80% of patients [ 1 , 10 ]. Faricimab provides rapid and meaningful anatomical improvement, including patients previously treated with aflibercept, and offers the potential for extended dosing intervals – even beyond 16 weeks in some cases. Real-world evidence confirms that faricimab delivers strong fluid control and anatomical benefits, including the resolution of challenging features such as intraretinal and subretinal fluid, while maintaining a favourable safety profile with inflammation and endophthalmitis rates comparable to other anti-VEGF therapies [ 11 ]. As part of the Polish drug reimbursement system, drug programmes are crucial in providing patients with access to advanced, high-cost therapies, primarily targeting those with prior unsuccessful treatments or rare diseases. These programmes cover both oncological and non-oncological diseases [ 12 ]. The drug programme B.70 Treatment of Patients with Retinal Diseases includes therapies for patients with nAMD and DME. Of the 134 programmes available in 2023 [ 13 ], it serves the largest number of patients, with enrolment exceedingly twice that of the second most populated programme (for multiple sclerosis). In the B.70 programme, patients treated primarily include those with nAMD and DME with foveal involvement. Eligible patients must meet strict diagnostic criteria such as documented choroidal neovascularisation confirmed by optical coherence tomography (OCT) and fluorescein angiography, specific visual acuity levels, and no significant structural retinal damage. The treatment protocol includes intravitreal injections of anti-VEGF agents and corticosteroid implants, with dosing tailored to individual patient response following a “treat-and-extend” approach. The drug programme reimburses for aflibercept 2 mg (AFL), brolucizumab (BRO), ranibizumab (RAN), bevacizumab (BEV), dexamethasone (DEX), and, from January 2024, faricimab (FAR) [ 14 ]. The objective of this study was to evaluate the impact of introducing faricimab into a publicly funded drug programme, particularly in terms of treatment frequency and resource optimisation. By examining the projected uptake of FAR's and its impact on administration rates compared to existing treatments, the study provided insights into potential efficiencies and patient outcomes. The assessment framework took a structured approach to forecasting patient treatment trends, modelling drug administration frequencies, and assessing the capacity for additional patient treatments. This comprehensive analysis also addressed potential challenges and constraints associated with implementing these changes within the Polish healthcare system. Methods The analysis comprised the following stages: Estimation of patient forecasts : projecting the number of patients to be treated within the drug programme B.70. Estimation of the potential market share for the new drug faricimab : determining potential adoption rates for FAR within the target population. Simulation of average drug administrations : calculating the average number of administrations for drugs currently used in the programme compared to FAR. Comparative analysis of injection frequency : comparing the number of intravitreal injections in patients treated with reimbursed drugs available before 2024 (AFL, BRO, RAN) with the scenario in which FAR is reimbursed and assumes a given market share. Estimation of additional patients treated : estimating the number of additional patients who could be treated in the programme as a result of avoided injections due to FAR use. Identification of potential limitations/challenges : highlighting possible limitations or risks associated with these changes in the organisation of the healthcare system in Poland. The most recent data were included − 2023 and, where available, mid-2024. The cost estimates were made in Polish zloty (zl), while the publication presents them in Euro. The exchange rate used is the average cumulative rate as of October 2024 : €1 = zl 4.3072 [ 15 ]. Time horizon The analysis was conducted over a multi-year time horizon, specifically covering the years 2025, 2030, and 2035. This approach allowed for the assessment of both short- and long-term potential impact of FAR's introduction on patient treatment patterns, resource allocation, and overall health system demands. Selecting these target years enabled the study to capture trends and project future needs within a structured timeframe, providing valuable insights for policymakers and healthcare providers. Patient population forecasting Demographic changes and trends in disease incidence were considered when estimating the projected number of patients eligible for treatment under the drug programme over the specified time horizon. This estimate included the total number of patients with nAMD [ 16 – 19 ] and DME [ 20 – 22 ] with foveal involvement, as well as identifying those specifically eligible for inclusion in the drug programme [ 16 – 22 ] for intravitreal injections of anti-VEGF agents. The patient forecast was made in three scenarios, projecting the number of patients to be treated under the drug programme B.70, based on various data sources [ 13 , 16 , 23 , 24 ] and assumptions, which are outlined in detail below. In the minimum scenario, it was assumed that the proportion of patients treated with anti-VEGF agents predicted based on 2023 [ 23 ] and mid-2024 [ 24 ] data, would remain constant across all age groups in subsequent years. Any increase in patient numbers would result from population ageing and a larger number of individuals in the 60 + age group [ 16 ]. This trend may indicate a gradual stabilisation and reaching of full capacity within the drug programme for patients with retinal diseases. Therefore, in the likely scenario, it was assumed that in 2025 the proportion in each age group would increase at the same rate as in 2024 and subsequently remaining at the 2025 level in the following years. In the maximum scenario, the number of patients treated with AFL, BRO, and RAN was estimated using linear regression based on data from 2017 to 2024, fitting a straight line to the observed trend to project future values [ 13 , 24 ]. In the final estimates, the analysis focused on a refined population size, including only patients treated with AFL, BRO, and RAN, as these drugs serve as comparators for the FAR [ 25 ]. For the minimum and likely scenarios, in which the total number of individual patients in the retinal disease treatment drug programme was estimated, it was assumed that 92.5% of patients would receive treatment with AFL, BRO, and RAN products (Table 1 ). Table 1 Characteristics of the population treated in the drug programme B.70–2023 Parameters Population treated in the drug programme B.70* n (%) References Number of patients in drug programme 51,281 (100) 21 Number of patients including those who received treatment: 49,354 (96) 21 AFL 35,377 (69) 21 BRO 6,242 (12) 21 RAN 5,815 (11) 21 BEV 7,639 (15) 21 DEX 900 (2) 21 Percentage of nAMD patients (%) 83.4 24 Percentage of DME patients (%) 16.6 24 AFL aflibercept 2 mg; B.70 - drug programme Treatment of Patients with Retinal Diseases; BEV bevacizumab; BRO brolucizumab; DEX dexamethasone; DME diabetic macular edema; n number of patients; nAMD neovascular age-related macular degeneration; RAN ranibizumab. *As treatment switching is possible, the percentages may not sum to 100%. Market share of faricimab Considering the provisions of the drug programme B.70 [ 14 ], the market share was estimated based on the assumption that 40% of: previously untreated patients, or those on ineffective treatment and switching therapies, would be treated with FAR in the first year, with a gradual increase of 1% in subsequent years. This assumption is based on the calculations by Marketing Authorisation Holder. It was also assumed that a proportion of patients would discontinue treatment with other drugs : 14% in the first year and 24% in subsequent years [ 13 ]. Modelling of drug administration frequency To estimate the average number of administrations for the population with retinal diseases requiring anti-VEGF injections, data on the average number of administrations per patient for each drug recorded in 2023 were used [ 23 ]. Options including the average of all administrations were considered. Additionally, to exclude patients who were not treated throughout the whole year, averages were calculated for those who received at least 3, 4 and 5 injections (Table 2 ). Table 2 Number of administrations and reduction in the number of administrations Parameters AFL BRO RAN References Drug share (%) 75 13 12 11,21 Average number of administrations per patient per year, n 5 + inj. 7.04 6.25 6.80 21 4 + inj. 6.42 5.71 6.16 21 3 + inj. 5.98 5.29 5.68 21 All 5.32 4.61 4.85 21 Reduction in FAR administrations in patients with nAMD (%) All -13.8 -17.8 -30.0 8 2 + years -13.8 -17.8 -30.0 8 Reduction in FAR administrations in patients with DME (%) All -9.1 -10.0* -10.9 7 2 + years -7.7 -9.0* -10.2 7 AFL aflibercept 2 mg; BRO brolucizumab; DME diabetic macular edema; FAR faricimab; inj. injections; n number of administrations; nAMD neovascular age-related macular degeneration; RAN ranibizumab. *Average of the values for AFL and RAN. The effect of the new drug (percentage reduction in the number of administrations) was estimated based on clinical trial results [ 8 , 9 ]. BRO in DME has been reimbursed since January 2024, and therefore, data on its usage frequency has not yet been published, the reduction rate was estimated based on the average reduction observed for the other two drugs. The reduction in the number of FAR administrations was presented as an average for all years considered, as well as for the second and subsequent years. This excludes the loading phase, which occurs at the beginning of treatment and is characterised by more frequent drug administration. The simulation was conducted in Microsoft Office Excel® to model the projected reduction in medication administrations within drug programme, following the introduction of FAR. The model used Monte Carlo simulation techniques with 1,000 iterations to estimate the average reduction in the total number of administrations for patients with nAMD and DME. In each iteration, drugs were randomly assigned to individual patients based on real-world utilisation rates: AFL was assigned to 75% of patients, BRO to 13%, and RAN to 12% [ 23 ]. Each selected drug was then assigned a predetermined number of administrations per year [ 23 ], based on local data on administration frequency. Patients were then randomly assigned to a disease within the programme, with nAMD accounting for 83% of cases and DME for 17% [ 26 ]. The reduction in the number of administrations differs for nAMD and DME. Based on the results of the Monte Carlo simulation, the average total number of injections was estimated for AFL, BRO, and RAN combined, and FAR separately. Comparative Analysis of Injection Frequency Considering the modelled average number of administrations for AFL, BRO, and RAN (as described above), the administration frequency for FAR, the projected market share of FAR, and the estimated patient population, the total number of injections was calculated for both populations, one including FAR and one not. Estimation of Additional Patients Treated Estimates of the additional number of patients who could be treated with the same financial and medical staff resources were conducted using costs allocated to healthcare services: including intravitreal injections (€149.41) and diagnostic tests (€80.91 and €98.28 for patients with nAMD and DME, respectively) [ 27 ]. Diagnostic tests are performed prior to each drug administration to assess both the efficacy and safety of the treatment [ 28 ]. These tests include an ophthalmological examination with visual acuity measured with Snellen or Early Treatment of Diabetic Retinopathy Study (ETDRS) charts and OCT [ 14 ]. Other optional tests may include fundus photography, fluorescein angiography, or angio-OCT, with indocyanine green angiography reserved for diagnostically complex cases. Consequently, each avoided drug administration also saves the resources associated with the necessary diagnostic procedures, averaging €233.99 (Table 3 ). Table 3 Costs assigned to healthcare services in B.70 drug programme Cost category Healthcare service Unit cost in 2024 Number of reimbursed tests in 2023 Average cost References Average cost per single drug administration Intravitreal injections €149.41 n/a €233.99 27,25 Monitoring tests in nAMD €80.91 194,873 24,25,27 Monitoring tests in DME €98.28 52,191 24,25,27 Average costs per patient n/a n/a €1,407.18* 21,27 DME diabetic macular edema; n/a not applicable; nAMD neovascular age-related macular degeneration. *Average cost per patient in the B.70 programme was calculated by dividing total costs (€64,945,531) for drug administration, outpatient admissions, qualification for treatment, and diagnostics (2023) by the number of treated patients (Table 1 ), with an 11% increase in service valuation in 2024. The average cost per patient per year for services in the B.70 programme was estimated by considering the costs of drug administration and other outpatient admissions (€39,436,740), qualification for treatment (€3,067,032), and diagnostics (€22,441,759) in 2023 [ 23 ]. The total cost (€64,945,531) was divided by the number of patients treated (Table 1 ) and adjusted for the approximately 11% increase in service valuation between 2023 and 2024 [ 29 ]. The average total cost of services per patient in the B.70 programme in 2024 was €1,407.18 (Table 3 ). Identification of Potential Limitations/Challenges The number of ophthalmologists in Poland was identified, and changes to this number in the coming years were analysed. Additionally, the situation regarding waiting times for medical services related to eye diseases was studied, including access to the drug programme. Results According to various sources, the total number of patients in Poland with nAMD and DME is projected to range between 180,130 and 347,913 in 2025 and between 201,073 and 394,668 in 2035 (Supplemental Figure S1 ). This includes an estimated 35,724 − 44,389 DME patients in 2025 and 42,661 − 52,576 in 2035, alongside approximately 135,741 − 312,189 nAMD patients in 2025 and 148,497 − 352,007 in 2035 (Table 4 ). Table 4 Population size and number of ophthalmologists Parameters 2025 2030 2035 Number of patients in Poland, n nAMD (min – max) 135,741–312,189 144,353–341,519 148,497–352,007 DME* (min - max) 35,724–44,389 39,168–48,817 42,661–52,576 Number of patients in the B.70 drug programme, n minimum 59,049 66,592 72,672 likely 65,182 81,362 99,462 maximum 61,692* 89,651 117,610 Number of patients treated with FAR, AFL, BRO and RAN, n minimum 54,619 61,597 67,221 likely 60,292 75,258 92,000 maximum 57,064** 82,925 108,787 Number of ophthalmologists, n Per 100,000 inhabitants in the 60 + age group 49.7 49.6 48.6 AFL aflibercept 2 mg; B.70 drug programme Treatment of Patients with Retinal Diseases; BRO brolucizumab; DME diabetic macular edema; FAR faricimab; max maximum; min minimum; nAMD neovascular age-related macular degeneration; RAN ranibizumab. *Clinically significant DME with foveal involvement. **In the maximum scenario, the number of patients in 2025 is lower than in the likely scenario; however, this number increases significantly in 2030 and 2035. The analysis indicates that the number of patients treated with anti-VEGF agents will increase by more than half, reaching 92,000 (range: 67,221 − 108,787) by 2035. Meanwhile, the number of ophthalmologists per 100,000 inhabitants over the age of 60 is expected to decrease slightly. Irrespective of the assumptions made about the administration frequency of AFL, BRO, RAN, and the reductions applied, FAR treatment is associated with an approximate 14–15% decrease in injections’ number (Fig. 1 ). The FAR market share was estimated at 25.3%, 48.8% and 60.0% in 2025, 2030, and 2035, respectively. In the base case analysis, a likely population estimate was assumed, focusing on patients receiving at least 3 injections within a year, along with a reduction in administrations number based on data from the second and subsequent years. Under the primary scenario assumptions, the analysis projects an increasing capacity for additional patients within the drug programme as FAR is introduced. Specifically, the estimated number of additional patients that could be accommodated with the same healthcare resources is estimated to reach 2,115 in 2025, 5,103 in 2030, and 7,662 in 2035 (Table 5 ). Table 5 Additional number of patients - results Parameters 2025 2030 2035 Base case scenario Population, n 60,292 75,258 92,000 Average number of inj. per patient AFL, BRO, RAN 5.82 FAR 4.98 Number of inj. per population Without FAR 350,611 437,640 535,000 With FAR 337,890 406,950 488,920 Difference 12,721 30,691 46,080 Additional number of patients, n 2,115 5,103 7,662 Minimal scenario Population, n 54,619 61,597 67,221 Average number of inj. per patient AFL, BRO, RAN 5.15 FAR 4.42 Number of inj. per population, n Without FAR 281,357 317,299 346,269 With FAR 271,228 295,222 316,679 Difference 10,128 22,077 29,591 Additional number of patients, n 1,684 3,671 4,920 Maximal scenario Population, n 57,064 82,925 108,787 Average number of inj. per patient AFL, BRO, RAN 6.87 FAR 5.86 Number of inj. per population, n Without FAR 391,832 569,408 746,985 With FAR 377,367 528,782 681,527 Difference 14,464 40,626 65,459 Additional number of patients, n 2,405 6,755 10,885 AFL aflibercept 2 mg; BRO brolucizumab; inj. injections; n number of items; FAR faricimab; RAN ranibizumab. ……Table 5 here……… This suggest that FAR has the potential to enhance programme efficiency over time, allowing a growing number of patients to access treatment for retinal diseases without requiring an expansion of healthcare funding or infrastructure. In the minimum scenario, the analysis projects that an additional 1,684 patients could be treated within the B.70 programme in 2025, increasing to 3,671 in 2030, and reaching 4,920 in 2035. This reflects a modest but steady growth in capacity to treat more patients with the same healthcare resources, as FAR reduces the frequency of required injections. In the maximum scenario, the projected increase in patient capacity is significantly higher, with an additional 2,405 patients in 2025, 6,755 in 2030, and 10,885 in 2035. This scenario demonstrates the potential impact of FAR in maximising resource efficiency and enabling more patients to receive treatment as the drug’s uptake grows over time. Most individuals for whom services were reimbursed under the B.70 drug programme received them within a maximum of 6 months (99% of those on the waiting list), with approximately 3 out of 4 individuals receiving services within 1 month [ 26 , 30 – 33 ] (Supplemental Table S1 , Supplemental Figure S2). Meanwhile, the number of people on waiting lists receiving services at ophthalmology outpatient centres increased by 88% in 2023 (374,000 patients) compared with 2019 (198,000 patients) [ 26 , 30 – 33 ] (Supplemental Table S2). Discussion This study provides a comprehensive analysis of the real-world administration rates of AFL, BRO, and RAN in the Polish healthcare system, assessing the potential impact of introducing FAR reimbursement on improving access to ophthalmic services. By presenting current usage patterns of reimbursed anti-VEGF treatments, this work provides valuable insights into the current demand and frequency of intravitreal injections. The analysis simulates how FAR, with its unique dual mechanism of action and longer lasting therapeutic effect, could reduce the number of injections required per patient. This reduction would have significant implications for healthcare resource allocation, as it could free up capacity within ophthalmology clinics, enabling a greater number of patients with retinal diseases, to access timely and effective treatment under the B.70 drug programme. The study projects the potential increase in patient capacity under different scenarios, demonstrating how FAR’s adoption could alleviate some of the pressure on Poland’s ophthalmology services. Given the expected rise in retinal disease prevalence due to an ageing population, this work emphasises the pivotal role that FAR could play in enhancing resource efficiency, optimising patient care, and addressing the mounting demand within the healthcare system, all without requiring additional financial or human resources. In this context, the results underscore the importance of FAR reimbursement as a strategy to improve access to advanced retinal disease therapies, ultimately contributing to better patient outcomes and healthcare system sustainability. The Polish Society of Ophthalmic Surgeons states that Poland offers world-class treatment for retinal diseases. The society highlights the importance of early diagnosis and prompt initiation of treatment, as delays can result in irreversible retinal changes. Effective treatment options are currently available, including anti-VEGF agents. The statement also acknowledges the ongoing development of new drugs, aiming at extending the intervals between injections, which would benefit both patients and the healthcare system [ 34 ]. This context underscores the importance of timely access to advanced therapies and serves as a basis for discussing potential improvements and challenges in the management of retinal diseases within the Polish healthcare system. Six months after introducing the public funding for FAR, its market share among anti-VEGF agents had reached 6% [ 24 ]. This confirms the initial assumption of capturing 40% of new patients and those switching treatment. By the end of the first year, it is expected that 11% will be using FAR. Despite the increase in services, there is still an unmet need for access to ophthalmologists in Poland. This shortage could delay the diagnosis of retinal diseases such as nAMD and DME, potentially increasing the demand for treatment within the B.70 drug programme. As the population ages, the prevalence of these conditions is likely to increase, highlighting the need for greater access to both ophthalmic consultations and drug programmes. The situation highlights the importance of addressing the resource constraints in eye care to meet the anticipated demand and ensure timely interventions for retinal disease management. In 2023, more than €100 million was allocated from public funds for the treatment of patients with retinal diseases under the B.70 drug programme, with more than 60% of the total cost attributed to medical services [ 23 ]. Reducing the number of drug administrations, while maintaining the efficacy and safety of the treatment, will optimise available resources, including financial and human resources, enabling more efficient allocation of funds and personnel. This approach would not only reduce the financial burden on the healthcare system but also ensure that resources are directed towards providing comprehensive and high-quality care for patients with retinal diseases, ultimately improving patient outcomes. A 2014 systematic review [ 35 ] provides a comprehensive analysis of the global prevalence of age-related macular degeneration. The review includes projections for the disease burden up to the year 2040, highlighting significant trends in the increasing prevalence of nAMD worldwide. Europe experiences the highest prevalence of nAMD, with a rate of 12.33%, which is significantly higher than the global average of 8.69%, as revealed by a meta-analysis of the available data. According to the review’s projections, 288 million people worldwide are expected to be affected by AMD by 2040, representing an almost 50% increase compared to 2020. Given that a neovascular form accounts for approximately 15–20% of all AMD cases [ 36 ], this would translate into 43–58 million individuals globally living with nAMD by 2040. These figures align with those obtained in our work, emphasising the growing challenge posed by the increasing number of patients with nAMD. When reviewing the impact of faricimab reimbursement on healthcare system accessibility for retinal disease treatment in Poland, a significant gap in the literature becomes apparent: there are limited studies assessing the multidimensional implications of reimbursement policies. Most of the available studies focus on the current patient costs and disease burden, without evaluating the broader systemic impacts of treatment innovations. Patients with nAMD and those with DME represent a significant economic burden on the healthcare system. High treatment costs, associated with frequent intravitreal injections, numerous ophthalmology visits, and diagnostic procedures, drive a substantial increase in healthcare expenditure. Findings from a nationwide French study [ 37 ] on the real-life management of nAMD show that the total treatment costs for nAMD patients are twice as high as for control patients (those without nAMD), primarily due to the higher number of medical visits and ophthalmic procedures, as well as increased transport costs. The results of the latest study [ 38 ] suggest that the 3-year treatment costs for patients with DME, as estimated for matched cohorts, can be nearly twice as high as those for patients without DME. Patients with DME require significantly more outpatient and inpatient visits than patients with diabetes mellitus without DME [ 38 ]. Optimising nAMD and DME management, particularly by reducing the frequency of drug administrations while preserving treatment efficacy and safety, could significantly decrease demand for ophthalmology services and reduce associated treatment costs. Introducing therapies with longer dosing intervals and predictable efficacy could not only relieve pressure on healthcare resources but also enhance patient quality of life and ensure a more effective use of medical services [ 37 ]. Similar conclusions were reached in a recent Spanish study [ 39 ], which suggests that managing of nAMD patients significantly impacts the healthcare system burden, which is expected to increase as the population ages and the number of nAMD patients rises. Both DME and nAMD impose a significant economic burden, as highlighted by a Slovak study [ 40 ], which estimated the annual costs for patients with DME to be €45 million, compared to €106 million for those with nAMD. Therefore, more effective therapies with longer-lasting effects could be beneficial in extending treatment intervals, thereby reducing the burden on patients and their caregivers and improving the utilisation of healthcare resources. This context highlights the necessity for studies that explore the potential multidimensional impacts of reimbursement for extended-dosing treatments such as faricimab, as they could provide valuable insights into improving healthcare accessibility for retinal disease patients not only in Poland, but also worldwide. Uncertainty in the data may also stem from estimating the number of patients in the drug programme. As a forecast, this is based on assumptions and projections derived from current trends and available data. However, these projections are inherently subject to change due to various factors, such as changes in patient demographics, disease prevalence, treatment patterns, or healthcare policies. What is certain is that the number of patients will continue to rise as the population ages. The real question, however, is how fast this growth will occur and whether the public payer will be able to ensure that all needed patients have access to necessary treatments. These uncertainties highlight the challenges of making accurate long-term projections, so any estimates should therefore be treated with caution. A 2 mg dose of AFL was used to estimate the number of doses, as it was the only reimbursed option until the end of 2023 (8 mg dose has been reimbursed since October 2024). Notably, the 8 mg dose has a dosing frequency similar to FAR. A limitation of the analysis is the assumption of fixed costs from 2024 throughout the considered time horizon. With FAR introduction into the reimbursement system is expected to further reduce the average cost per patient in the coming years. However, the medical service cost is also expected to increase due to factors such as inflation, rising healthcare salaries, and the growing fixed costs for healthcare providers. Conclusions The analysis of data on the implementation of the nAMD and DME treatment programme in Poland indicates significant untapped potential for the public payer in terms of optimising treatment organisation and enhancing patient access to care. Despite the large number of potential patients, only a small proportion receive treatment [ 41 ]. The introduction of FAR reimbursement is expected to significantly improve long-term access to ophthalmic services in Poland, particularly within the retinal disease programme, by reducing the frequency of required injections. This shift underscores the potential for greater resource efficiency, enabling more patients to benefit from the programme without the need of extra funding or healthcare resources. Such improvements are critical in the context of pressing public health challenges, including ageing population, rising prevalence of nAMD and DME, and a stagnant yet insufficient number of ophthalmologists. Abbreviations AFL aflibercept; BEV bevacizumab; BRO brolucizumab; DEX dexamethasone; DME diabetic macular edema; ETDRS Early Treatment of Diabetic Retinopathy Study; EMA European Medicines Agency; FAR faricimab; inj. injection; max maximum; min minimum; n number of patients ; nAMD neovascular age-related macular degeneration; OCT optical coherence tomography; RAN ranibizumab; VEGF vascular endothelial growth factor. Declarations Ethics approval and consent to participate: Not applicable Consent for publication: Not applicable Availability of data and materials: The datasets analysed during the current study are available from the corresponding author on reasonable request. Competing interests: AM is employed by the sponsoring company; however, his role in the study was independent and based solely on scientific and methodological standards. Funding: This study received the financial support from Roche Polska, Poland. Authors' contributions: All authors contributed equally to the design of the article and the interpretation of the data. JK performed the statistical analysis. JK, JA, and AM drafted the manuscript, while MS, MDT, and RR provided revisions. JA ensured administrative and technical support. All authors reviewed and approved the final manuscript. Acknowledgements: Not applicable References Nasimi S, Nasimi N, Grauslund J, Vergmann AS, Subhi Y. Real-World Efficacy of Intravitreal Faricimab for Diabetic Macular Edema: A Systematic Review. J Pers Med. 2024 Aug 28;14(9):913; https://doi.org/10.3390/jpm14090913 Bantounou MA, Elsheikh M, Ijasan A, et al. Real-world experience of intravitreal faricimab injection in previously treated neovascular age-related macular degeneration eyes: a case series. BMC Ophthalmol. 2025;25:117; https://doi.org/10.1186/s12886-025-03953-9 Joussen AM, Ricci F, Paris LP, et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021;35:1305–1316; https://doi.org/10.1038/s41433-020-01377-x Khan M, Aziz AA, Shafi NA, Abbas T, Khanani AM. Targeting Angiopoietin in Retinal Vascular Diseases: A Literature Review and Summary of Clinical Trials Involving Faricimab. Cells. 2020 Aug 10;9(8):1869; https://doi.org/10.3390/cells9081869 Yufeng X, Ningxi H, Mingzhi S, et al. Real-world outcomes of a loading phase with intravitreal faricimab in refractory Neovascular Age-Related Macular Degeneration (nAMD) patients. BMC Ophthalmol. 2025;25:347; https://doi.org/10.1186/s12886-025-04212-7 Eter N, Singh RP, Abreu F, et al. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111; https://doi.org/10.1016/j.xops.2021.100111. Khanani AM, Guymer RH, Basu K, et al. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. https://doi.org/10.1016/j.xops.2021.100076. Wykoff CC, Abreu F, Adamis AP, et al. YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755; https://doi.org/10.1016/S0140-6736(22)00018-6. Heier JS, Khanani AM, Quezada Ruiz C, et al. TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740; https://doi.org/10.1016/S0140-6736(22)00010-1. Nasimi N, Nasimi S, Grauslund J, Vergmann AS, Subhi Y. Real-world efficacy of intravitreal faricimab for neovascular age-related macular degeneration: a systematic review. Int J Retina Vitreous. 2024 Jul 12;10(1):48; https://doi.org/10.1186/s40942-024-00566-0. Penha FM, Masud M, Khanani ZA, et al. Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME. Int J Retin Vitr. 2024;10:5; https://doi.org/10.1186/s40942-024-00525-9 Mela A, Poniatowski ŁA, Drop B, et al. Overview and Analysis of the Cost of Drug Programs in Poland: Public Payer Expenditures and Coverage of Cancer and Non-Neoplastic Diseases Related Drug Therapies from 2015-2018 Years. Front Pharmacol. 2020 Aug 14;11:1123; https://doi.org/10.3389/fphar.2020.01123. National Health Fund. Statistics. Drug Statistics. Drug Programmes. https://statystyki.nfz.gov.pl/DrugPrograms Accessed October 30, 2024. 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Warsaw: Instytut Ochrony Zdrowia; 2016. p. 101-115. ISBN 978-83-944863-2-7. Mekjavić PJ, Balciuniene VJ, Ceklic L, et al. The Burden of Macular Diseases in Central and Eastern Europe - Implications for Healthcare Systems. Value Health Reg Issues. 2019;19:1-6; https://doi.org/10.1016/j.vhri.2018.11.002. "Retina AMD Polska" Portal, Roche. Report: nAMD - The path from diagnosis to treatment. 2023. Available from: http://retinaamd.org.pl/wp-content/uploads/2023/03/Retina_Raport-FIN.pdf . Accessed October 22, 2024. Map of health needs, Epidemiological forecast. https://basiw.mz.gov.pl/mapy-informacje/mapa-2022-2026/analizy/prognoza-epidemiologiczna/ Accessed October 22, 2024. Report No: OT.4221.41.2021. Bevacizumab for the indication: treatment of diabetic macular edema (DME) (ICD10: H36.0). https://bipold.aotm.gov.pl/assets/files/zlecenia_mz/2021/055/RPT/55_OT_4221_41_2021_Bewacyzumab_DME_BIP_REOPTR.pdf Accessed October 23, 2024. Minassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England, Br J Ophthalmol. 2012 Mar;96(3):345-9; https://doi.org/10.1136/bjo.2011.204040. Map of Health Needs, Drug Programmes. https://basiw.mz.gov.pl/en/maps-of-health-needs/map-of-health-needs-for-the-period-2022-2026/analyses/drug-programmes/ Accessed October 08, 2024. NHF Council Resolutions. Resolution No. 29/2024/IV dated October 17, 2024, regarding the adoption of the periodic performance report of the National Health Fund for the second quarter of 2024. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-292024iv,6679.html Accessed October 25, 2024. Agency for Health Technology Assessment and Tariff System in Poland. Application for reimbursement of the drug Vabysmo (faricimab) for the indication: Treatment of patients with retinal diseases (ICD-10: H35.3, H36.0). Verification analysis. https://bip.aotm.gov.pl/assets/files/zlecenia_mz/2023/011/AWA/011_AWA_OT.423.1.6.2023_Vabysmo_BIP_REOPTR.pdf Accessed October 29, 2024. NHF Council Resolutions. Resolution No. 5/2024/IV dated April 2, 2024, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2023. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-52024iv,6655.html Accessed October 21, 2024. Order No. 76/2024/DGL of the President of the NHF of 02 August 2024 amending the order on determining terms of concluding and performing contracts for inpatient treatment under drug programmes. National Health Fund. https://baw.nfz.gov.pl/NFZ/document/43336/Zarzadzenie-76_2024_DGL Accessed October 25, 2024. Order No. 175/2023/DGL of the President of the NHF of 30 November 2023 order on determining terms of concluding and performing contracts for inpatient treatment under drug programmes. National Health Fund. https://baw.nfz.gov.pl/NFZ/document/2095/Zarzadzenie-175_2023_DGL Accessed October 25, 2024. Information on Concluded Contracts. https://aplikacje.nfz.gov.pl/umowy/Provider/Search?Branch=01 Accessed October 18, 2024. NHF Council Resolutions. Resolution No. 6/2020/III dated March 20, 2020, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2019. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-62020iii,6527.html Accessed October 21, 2024. NHF Council Resolutions. Resolution No. 5/2021/IV dated March 12, 2021, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2020. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-52021iv,6555.html Accessed October 21, 2024. NHF Council Resolutions. Resolution No. 3/2022/IV dated March 16, 2022, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2021. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-32022iv,6592.html Accessed October 21, 2024. NHF Council Resolutions. Resolution No. 8/2023/IV dated March 20, 2024, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2022. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-82023iv,6627.html Accessed October 21, 2024. World-Class Treatment of Retinal Diseases. Practical Medicine Online Portal. https://www.mp.pl/pacjent/okulistyka/aktualnosci/319677,leczenie-chorob-siatkowki-na-swiatowym-poziomie Accessed October 31, 2024. Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. https://doi.org/10.1016/S2214-109X(13)70145-1. Chaudhuri M, Hassan Y, Bakka Vemana PPS, Bellary Pattanashetty MS, Abdin ZU, Siddiqui HF. Age-related macular degeneration: an exponentially emerging imminent threat of visual impairment and irreversible blindness. Cureus. 15(5):e39624. https://doi.org/10.7759/cureus.39624 Korobelnik JF, Delcourt C, Creuzot-Garcher C, et al. Real-life management of neovascular age-related macular degeneration (nAMD) in France: a nationwide observational study using retrospective claims data. J Med Econ. 2021 Jan-Dec;24(1):1087-1097. https://doi.org/10.1080/13696998.2021.1971416. Choi K, Park SJ, Yoon H, et al. Patient-Centered Economic Burden of Diabetic Macular Edema: Retrospective Cohort Study. JMIR Public Health Surveill. 2024 Oct 8;10:e56741. https://doi.org/10.2196/56741 Pina Marín B, Gajate Paniagua NM, Gómez-Baldó L, Gallego-Pinazo R. Burden of disease assessment in patients with neovascular age-related macular degeneration in Spain: Results of the AMD-MANAGE study. Eur J Ophthalmol. 2022 Jan;32(1):385-394. https://doi.org/10.1177/11206721211001716. Janco L, Stefanickova J, Busanyova B, et al. Economic burden of age-related macular degeneration and diabetic macular edema in Slovakia: a cost-of-illness analysis. Bratisl Med J. 2025;126:544–51. https://doi.org/10.1007/s44411-025-00140-6 Seweryn M, Leszczyńska A, Teper S. Potential in the treatment of neovascular Age-related Macular Degeneration and Diabetic Macular Edema in Poland. -population needs and access to therapy. J Health Policy Outcomes Res. 2024, 2 https://doi.org/10.7365/JHPOR.2024.2.1 Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7299149","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":498557519,"identity":"ec3348eb-10e2-4000-a6cf-4d6a881c8035","order_by":0,"name":"Michał Seweryn","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6klEQVRIiWNgGAWjYDADNvYGBoYKEOsAED8gRgsfD1DpGZiWBGK0yEkkEKlFt//wMYmPew7nsUm+MfxwMIdBju9GAtsDfFrMbqSlSc54driYTTrHWOLgNgZjyRsJ7Ab4tfCY3eY5cDixTTrHQPrjNobEDUBbJPBqOX/+2+0/IC2SZ4x/AG2pJ6zlQA7bbQaQFgkeM5DDEgwIarmRZv6z50B6YhtPWpnFwW0ShjPPPGzH75fzhx8b/DhgnTi//fDmGwe32cjzHU8+9uADHi1Q0AxjSAAxYxthDQwMdSg8NmK0jIJRMApGwcgBAO+KV9Vdz/VtAAAAAElFTkSuQmCC","orcid":"","institution":"Andrzej Frycz Modrzewski Krakow University","correspondingAuthor":true,"prefix":"","firstName":"Michał","middleName":"","lastName":"Seweryn","suffix":""},{"id":498557520,"identity":"1b633977-d312-42d9-9124-0f47409f2ed6","order_by":1,"name":"Justyna Kopel","email":"","orcid":"","institution":"EconMed Europe","correspondingAuthor":false,"prefix":"","firstName":"Justyna","middleName":"","lastName":"Kopel","suffix":""},{"id":498557524,"identity":"a78f4579-02d1-4664-a0ae-c47e78da270e","order_by":2,"name":"Joanna Augustynska","email":"","orcid":"","institution":"EconMed Europe","correspondingAuthor":false,"prefix":"","firstName":"Joanna","middleName":"","lastName":"Augustynska","suffix":""},{"id":498557525,"identity":"b4037caf-014b-4909-8f41-8cc90ad5d069","order_by":3,"name":"Adam Mikołajewicz","email":"","orcid":"","institution":"Roche Polska","correspondingAuthor":false,"prefix":"","firstName":"Adam","middleName":"","lastName":"Mikołajewicz","suffix":""},{"id":498557527,"identity":"77ed55a8-0762-4e40-914e-524948065a3a","order_by":4,"name":"Mario Damiano Toro","email":"","orcid":"","institution":"Eye Clinic, University of Naples Federico II","correspondingAuthor":false,"prefix":"","firstName":"Mario","middleName":"Damiano","lastName":"Toro","suffix":""},{"id":498557528,"identity":"96549e92-38ae-445e-8d9e-cd868c99dcb9","order_by":5,"name":"Robert Rejdak","email":"","orcid":"","institution":"Medical University of Lublin","correspondingAuthor":false,"prefix":"","firstName":"Robert","middleName":"","lastName":"Rejdak","suffix":""}],"badges":[],"createdAt":"2025-08-05 09:53:47","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7299149/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7299149/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12913-026-14231-9","type":"published","date":"2026-02-23T15:57:06+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":89230644,"identity":"f825e3f1-f46d-4254-8624-307882078a7e","added_by":"auto","created_at":"2025-08-17 14:15:19","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":14629,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAverage annual number of administrations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAFL\u003c/em\u003e aflibercept 2 mg; \u003cem\u003eBRO \u003c/em\u003ebrolucizumab; \u003cem\u003eFAR\u003c/em\u003e faricimab; \u003cem\u003einj.\u003c/em\u003e injections; \u003cem\u003eRAN \u003c/em\u003eranibizumab.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7299149/v1/b857dabe6f8cc286882f7780.png"},{"id":103765427,"identity":"9919da3b-4ecf-4ac5-ad54-3e3da7de4133","added_by":"auto","created_at":"2026-03-02 16:01:02","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1038598,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7299149/v1/d32f93f7-324f-4148-b65c-45df714b0b27.pdf"},{"id":89230659,"identity":"c41dc93f-9b04-4116-82cb-ebe6ed837e15","added_by":"auto","created_at":"2025-08-17 14:15:19","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":113322,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryfileSeweryn1.08.docx","url":"https://assets-eu.researchsquare.com/files/rs-7299149/v1/b694d718b498c15cadc8dad8.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Multidimensional Evaluation of the Potential Impact of Faricimab Availability on Healthcare System Accessibility for Retinal Disease Treatment in Poland","fulltext":[{"header":"Background","content":"\u003cp\u003eDiabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) are two common eye diseases that can cause severe visual impairment, and if left untreated, even irreversible blindness [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Elevated levels of angiopoietin-2 and vascular endothelial growth factor (VEGF) play a key role in their pathogenesis, causing excessive growth of fragile and unstable subretinal blood vessels [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Leakage from their walls leads to the accumulation of fluids in the intraretinal spaces, gradually leading to structural damage and deterioration of visual function. VEGF overexpression further stimulates local inflammatory processes, accelerating disease progression and vision loss [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eFaricimab, the first and only medicine to reduce both vascular leakage and inflammation, is an innovative bispecific antibody that blocks both angiopoietin-2 and VEGF-A, registered by the European Medicines Agency (EMA) in 2022. This dual mechanism of disease control restores vascular stability in the eye more effectively than monospecific biologic therapies used previously, and the therapeutic effect lasts longer [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eFaricimab’s efficacy in DME and nAMD has been demonstrated in four randomised phase III clinical trials, encompassing over 3,200 participants in over 30 countries [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The novel therapy showed non-inferiority to aflibercept at the specified primary endpoint in all of the trials: mean change in best-corrected visual acuity, averaged over weeks 48, 52, and 56 in YOSEMITE/RHINE studies and over weeks 40, 44, and 48 in TENAYA/LUCERNE studies [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Durable vision gains with faricimab were achieved with a treat-and-extend dosing regimen, which allowed for longer intervals compared to aflibercept (which is dosed every 8 weeks). In DME flexible dosing enabled approximately 50% of patients to be treated with faricimab at intervals of up to 16 weeks, and around 70% of patients at intervals of at least 12 weeks. Similarly, in nAMD 45% of patients were able to maintain dosing intervals of up to 16 weeks, whereas those receiving aflibercept followed a fixed dosing regimen every 8 weeks [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe results of the randomised clinical trials have been replicated in routine clinical practice, where faricimab has enabled an extension of treatment intervals in both previously treated and treatment-naïve patients. The expected efficacy of the medication was maintained in 60–80% of patients [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Faricimab provides rapid and meaningful anatomical improvement, including patients previously treated with aflibercept, and offers the potential for extended dosing intervals – even beyond 16 weeks in some cases. Real-world evidence confirms that faricimab delivers strong fluid control and anatomical benefits, including the resolution of challenging features such as intraretinal and subretinal fluid, while maintaining a favourable safety profile with inflammation and endophthalmitis rates comparable to other anti-VEGF therapies [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAs part of the Polish drug reimbursement system, drug programmes are crucial in providing patients with access to advanced, high-cost therapies, primarily targeting those with prior unsuccessful treatments or rare diseases. These programmes cover both oncological and non-oncological diseases [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe drug programme B.70 Treatment of Patients with Retinal Diseases includes therapies for patients with nAMD and DME. Of the 134 programmes available in 2023 [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], it serves the largest number of patients, with enrolment exceedingly twice that of the second most populated programme (for multiple sclerosis).\u003c/p\u003e\u003cp\u003eIn the B.70 programme, patients treated primarily include those with nAMD and DME with foveal involvement. Eligible patients must meet strict diagnostic criteria such as documented choroidal neovascularisation confirmed by optical coherence tomography (OCT) and fluorescein angiography, specific visual acuity levels, and no significant structural retinal damage. The treatment protocol includes intravitreal injections of anti-VEGF agents and corticosteroid implants, with dosing tailored to individual patient response following a “treat-and-extend” approach. The drug programme reimburses for aflibercept 2 mg (AFL), brolucizumab (BRO), ranibizumab (RAN), bevacizumab (BEV), dexamethasone (DEX), and, from January 2024, faricimab (FAR) [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe objective of this study was to evaluate the impact of introducing faricimab into a publicly funded drug programme, particularly in terms of treatment frequency and resource optimisation. By examining the projected uptake of FAR's and its impact on administration rates compared to existing treatments, the study provided insights into potential efficiencies and patient outcomes. The assessment framework took a structured approach to forecasting patient treatment trends, modelling drug administration frequencies, and assessing the capacity for additional patient treatments. This comprehensive analysis also addressed potential challenges and constraints associated with implementing these changes within the Polish healthcare system.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe analysis comprised the following stages:\u003c/p\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eEstimation of patient forecasts\u003c/b\u003e: projecting the number of patients to be treated within the drug programme B.70.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eEstimation of the potential market share for the new drug faricimab\u003c/b\u003e: determining potential adoption rates for FAR within the target population.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eSimulation of average drug administrations\u003c/b\u003e: calculating the average number of administrations for drugs currently used in the programme compared to FAR.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eComparative analysis of injection frequency\u003c/b\u003e: comparing the number of intravitreal injections in patients treated with reimbursed drugs available before 2024 (AFL, BRO, RAN) with the scenario in which FAR is reimbursed and assumes a given market share.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eEstimation of additional patients treated\u003c/b\u003e: estimating the number of additional patients who could be treated in the programme as a result of avoided injections due to FAR use.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003e\u003cb\u003eIdentification of potential limitations/challenges\u003c/b\u003e: highlighting possible limitations or risks associated with these changes in the organisation of the healthcare system in Poland.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003cp\u003eThe most recent data were included − 2023 and, where available, mid-2024. The cost estimates were made in Polish zloty (zl), while the publication presents them in Euro. The exchange rate used is the average cumulative rate as of October 2024 : €1 = zl 4.3072 [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e\u003cb\u003eTime horizon\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe analysis was conducted over a multi-year time horizon, specifically covering the years 2025, 2030, and 2035. This approach allowed for the assessment of both short- and long-term potential impact of FAR's introduction on patient treatment patterns, resource allocation, and overall health system demands. Selecting these target years enabled the study to capture trends and project future needs within a structured timeframe, providing valuable insights for policymakers and healthcare providers.\u003c/p\u003e\u003cp\u003e\u003cb\u003ePatient population forecasting\u003c/b\u003e\u003c/p\u003e\u003cp\u003eDemographic changes and trends in disease incidence were considered when estimating the projected number of patients eligible for treatment under the drug programme over the specified time horizon. This estimate included the total number of patients with nAMD [\u003cspan additionalcitationids=\"CR17 CR18\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e–\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] and DME [\u003cspan additionalcitationids=\"CR21\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e–\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] with foveal involvement, as well as identifying those specifically eligible for inclusion in the drug programme [\u003cspan additionalcitationids=\"CR17 CR18 CR19 CR20 CR21\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e–\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] for intravitreal injections of anti-VEGF agents.\u003c/p\u003e\u003cp\u003eThe patient forecast was made in three scenarios, projecting the number of patients to be treated under the drug programme B.70, based on various data sources [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] and assumptions, which are outlined in detail below. In the minimum scenario, it was assumed that the proportion of patients treated with anti-VEGF agents predicted based on 2023 [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] and mid-2024 [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] data, would remain constant across all age groups in subsequent years. Any increase in patient numbers would result from population ageing and a larger number of individuals in the 60 + age group [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. This trend may indicate a gradual stabilisation and reaching of full capacity within the drug programme for patients with retinal diseases. Therefore, in the likely scenario, it was assumed that in 2025 the proportion in each age group would increase at the same rate as in 2024 and subsequently remaining at the 2025 level in the following years. In the maximum scenario, the number of patients treated with AFL, BRO, and RAN was estimated using linear regression based on data from 2017 to 2024, fitting a straight line to the observed trend to project future values [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn the final estimates, the analysis focused on a refined population size, including only patients treated with AFL, BRO, and RAN, as these drugs serve as comparators for the FAR [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. For the minimum and likely scenarios, in which the total number of individual patients in the retinal disease treatment drug programme was estimated, it was assumed that 92.5% of patients would receive treatment with AFL, BRO, and RAN products (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCharacteristics of the population treated in the drug programme B.70–2023\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eParameters\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePopulation treated in the drug programme B.70*\u003c/p\u003e\u003cp\u003en (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eReferences\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of patients in drug programme\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e51,281 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of patients including those who received treatment:\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003e49,354 (96)\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eAFL\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003e35,377 (69)\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eBRO\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003e6,242 (12)\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eRAN\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003e5,815 (11)\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eBEV\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003e7,639 (15)\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eDEX\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003e900 (2)\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePercentage of nAMD patients (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e83.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e24\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePercentage of DME patients (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e16.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003csup\u003e24\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003e\u003cem\u003eAFL\u003c/em\u003e aflibercept 2 mg; \u003cem\u003eB.70\u003c/em\u003e - drug programme Treatment of Patients with Retinal Diseases; \u003cem\u003eBEV\u003c/em\u003e bevacizumab; \u003cem\u003eBRO\u003c/em\u003e brolucizumab; \u003cem\u003eDEX\u003c/em\u003e dexamethasone; \u003cem\u003eDME\u003c/em\u003e diabetic macular edema; \u003cem\u003en\u003c/em\u003e number of patients; \u003cem\u003enAMD\u003c/em\u003e neovascular age-related macular degeneration; \u003cem\u003eRAN\u003c/em\u003e ranibizumab.\u003c/p\u003e\u003cp\u003e*As treatment switching is possible, the percentages may not sum to 100%.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMarket share of faricimab\u003c/b\u003e\u003c/p\u003e\u003cp\u003eConsidering the provisions of the drug programme B.70 [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], the market share was estimated based on the assumption that 40% of: previously untreated patients, or those on ineffective treatment and switching therapies, would be treated with FAR in the first year, with a gradual increase of 1% in subsequent years. This assumption is based on the calculations by Marketing Authorisation Holder. It was also assumed that a proportion of patients would discontinue treatment with other drugs : 14% in the first year and 24% in subsequent years [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e\u003cb\u003eModelling of drug administration frequency\u003c/b\u003e\u003c/p\u003e\u003cp\u003eTo estimate the average number of administrations for the population with retinal diseases requiring anti-VEGF injections, data on the average number of administrations per patient for each drug recorded in 2023 were used [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Options including the average of all administrations were considered. Additionally, to exclude patients who were not treated throughout the whole year, averages were calculated for those who received at least 3, 4 and 5 injections (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eNumber of administrations and reduction in the number of administrations\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003eParameters\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAFL\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eBRO\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eRAN\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eReferences\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003eDrug share (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e75\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e11,21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e\u003cp\u003eAverage number of administrations per patient per year, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 + inj.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7.04\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6.80\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 + inj.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6.42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5.71\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6.16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 + inj.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5.98\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5.29\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5.68\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAll\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5.32\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4.61\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4.85\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eReduction in FAR administrations in patients with nAMD (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAll\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-13.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-17.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-30.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e8\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 + years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-13.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-17.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-30.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e8\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eReduction in FAR administrations in patients with DME (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAll\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-9.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-10.0*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-10.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e7\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 + years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-7.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-9.0*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-10.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e7\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003e\u003cem\u003eAFL\u003c/em\u003e aflibercept 2 mg; \u003cem\u003eBRO\u003c/em\u003e brolucizumab; \u003cem\u003eDME\u003c/em\u003e diabetic macular edema; \u003cem\u003eFAR\u003c/em\u003e faricimab; \u003cem\u003einj.\u003c/em\u003e injections; \u003cem\u003en\u003c/em\u003e number of administrations; \u003cem\u003enAMD\u003c/em\u003e neovascular age-related macular degeneration; \u003cem\u003eRAN\u003c/em\u003e ranibizumab.\u003c/p\u003e\u003cp\u003e*Average of the values for AFL and RAN.\u003c/p\u003e\u003cp\u003eThe effect of the new drug (percentage reduction in the number of administrations) was estimated based on clinical trial results [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. BRO in DME has been reimbursed since January 2024, and therefore, data on its usage frequency has not yet been published, the reduction rate was estimated based on the average reduction observed for the other two drugs. The reduction in the number of FAR administrations was presented as an average for all years considered, as well as for the second and subsequent years. This excludes the loading phase, which occurs at the beginning of treatment and is characterised by more frequent drug administration.\u003c/p\u003e\u003cp\u003eThe simulation was conducted in \u003cem\u003eMicrosoft Office Excel®\u003c/em\u003e to model the projected reduction in medication administrations within drug programme, following the introduction of FAR. The model used Monte Carlo simulation techniques with 1,000 iterations to estimate the average reduction in the total number of administrations for patients with nAMD and DME.\u003c/p\u003e\u003cp\u003eIn each iteration, drugs were randomly assigned to individual patients based on real-world utilisation rates: AFL was assigned to 75% of patients, BRO to 13%, and RAN to 12% [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Each selected drug was then assigned a predetermined number of administrations per year [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e], based on local data on administration frequency. Patients were then randomly assigned to a disease within the programme, with nAMD accounting for 83% of cases and DME for 17% [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. The reduction in the number of administrations differs for nAMD and DME. Based on the results of the Monte Carlo simulation, the average total number of injections was estimated for AFL, BRO, and RAN combined, and FAR separately.\u003c/p\u003e\u003cp\u003e\u003cb\u003eComparative Analysis of Injection Frequency\u003c/b\u003e\u003c/p\u003e\u003cp\u003eConsidering the modelled average number of administrations for AFL, BRO, and RAN (as described above), the administration frequency for FAR, the projected market share of FAR, and the estimated patient population, the total number of injections was calculated for both populations, one including FAR and one not.\u003c/p\u003e\u003cp\u003e\u003cb\u003eEstimation of Additional Patients Treated\u003c/b\u003e\u003c/p\u003e\u003cp\u003eEstimates of the additional number of patients who could be treated with the same financial and medical staff resources were conducted using costs allocated to healthcare services: including intravitreal injections (€149.41) and diagnostic tests (€80.91 and €98.28 for patients with nAMD and DME, respectively) [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Diagnostic tests are performed prior to each drug administration to assess both the efficacy and safety of the treatment [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. These tests include an ophthalmological examination with visual acuity measured with Snellen or Early Treatment of Diabetic Retinopathy Study (ETDRS) charts and OCT [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Other optional tests may include fundus photography, fluorescein angiography, or angio-OCT, with indocyanine green angiography reserved for diagnostically complex cases. Consequently, each avoided drug administration also saves the resources associated with the necessary diagnostic procedures, averaging €233.99 (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cdiv class=\"gridtable\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCosts assigned to healthcare services in B.70 drug programme\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCost category\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHealthcare service\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eUnit cost in 2024\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNumber of reimbursed tests in 2023\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eAverage cost\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eReferences\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eAverage cost per single drug administration\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIntravitreal injections\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e€149.41\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003en/a\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003e€233.99\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e27,25\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMonitoring tests in nAMD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e€80.91\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e194,873\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e24,25,27\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMonitoring tests in DME\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e€98.28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e52,191\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e24,25,27\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003eAverage costs per patient\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003en/a\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003en/a\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e€1,407.18*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003csup\u003e21,27\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/table\u003e\u003c/div\u003e\u003cp\u003e\u003cem\u003eDME\u003c/em\u003e diabetic macular edema; \u003cem\u003en/a\u003c/em\u003e not applicable; \u003cem\u003enAMD\u003c/em\u003e neovascular age-related macular degeneration.\u003c/p\u003e\u003cp\u003e*Average cost per patient in the B.70 programme was calculated by dividing total costs (€64,945,531) for drug administration, outpatient admissions, qualification for treatment, and diagnostics (2023) by the number of treated patients (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), with an 11% increase in service valuation in 2024.\u003c/p\u003e\u003cp\u003eThe average cost per patient per year for services in the B.70 programme was estimated by considering the costs of drug administration and other outpatient admissions (€39,436,740), qualification for treatment (€3,067,032), and diagnostics (€22,441,759) in 2023 [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The total cost (€64,945,531) was divided by the number of patients treated (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) and adjusted for the approximately 11% increase in service valuation between 2023 and 2024 [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. The average total cost of services per patient in the B.70 programme in 2024 was €1,407.18 (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cb\u003eIdentification of Potential Limitations/Challenges\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe number of ophthalmologists in Poland was identified, and changes to this number in the coming years were analysed. Additionally, the situation regarding waiting times for medical services related to eye diseases was studied, including access to the drug programme.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eAccording to various sources, the total number of patients in Poland with nAMD and DME is projected to range between 180,130 and 347,913 in 2025 and between 201,073 and 394,668 in 2035 (Supplemental Figure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e). This includes an estimated 35,724\u0026thinsp;\u0026minus;\u0026thinsp;44,389 DME patients in 2025 and 42,661\u0026thinsp;\u0026minus;\u0026thinsp;52,576 in 2035, alongside approximately 135,741\u0026thinsp;\u0026minus;\u0026thinsp;312,189 nAMD patients in 2025 and 148,497\u0026thinsp;\u0026minus;\u0026thinsp;352,007 in 2035 (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePopulation size and number of ophthalmologists\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003eParameters\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2025\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2030\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2035\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eNumber of patients in Poland, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003enAMD (min \u0026ndash; max)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e135,741\u0026ndash;312,189\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e144,353\u0026ndash;341,519\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e148,497\u0026ndash;352,007\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDME* (min - max)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e35,724\u0026ndash;44,389\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e39,168\u0026ndash;48,817\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e42,661\u0026ndash;52,576\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eNumber of patients in the B.70 drug programme, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eminimum\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e59,049\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e66,592\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e72,672\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003elikely\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e65,182\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e81,362\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e99,462\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003emaximum\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e61,692*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e89,651\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e117,610\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eNumber of patients treated with FAR, AFL, BRO and RAN, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eminimum\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e54,619\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e61,597\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e67,221\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003elikely\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e60,292\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e75,258\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e92,000\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003emaximum\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57,064**\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e82,925\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e108,787\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of ophthalmologists, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePer 100,000 inhabitants in the 60\u0026thinsp;+\u0026thinsp;age group\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e49.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e49.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e48.6\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003eAFL\u003c/em\u003e aflibercept 2 mg; \u003cem\u003eB.70\u003c/em\u003e drug programme Treatment of Patients with Retinal Diseases; \u003cem\u003eBRO\u003c/em\u003e brolucizumab; \u003cem\u003eDME\u003c/em\u003e diabetic macular edema; \u003cem\u003eFAR\u003c/em\u003e faricimab; \u003cem\u003emax\u003c/em\u003e maximum; \u003cem\u003emin\u003c/em\u003e minimum; \u003cem\u003enAMD\u003c/em\u003e neovascular age-related macular degeneration; \u003cem\u003eRAN\u003c/em\u003e ranibizumab.\u003c/p\u003e\u003cp\u003e*Clinically significant DME with foveal involvement.\u003c/p\u003e\u003cp\u003e**In the maximum scenario, the number of patients in 2025 is lower than in the likely scenario; however, this number increases significantly in 2030 and 2035.\u003c/p\u003e\u003cp\u003eThe analysis indicates that the number of patients treated with anti-VEGF agents will increase by more than half, reaching 92,000 (range: 67,221\u0026thinsp;\u0026minus;\u0026thinsp;108,787) by 2035. Meanwhile, the number of ophthalmologists per 100,000 inhabitants over the age of 60 is expected to decrease slightly.\u003c/p\u003e\u003cp\u003eIrrespective of the assumptions made about the administration frequency of AFL, BRO, RAN, and the reductions applied, FAR treatment is associated with an approximate 14\u0026ndash;15% decrease in injections\u0026rsquo; number (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe FAR market share was estimated at 25.3%, 48.8% and 60.0% in 2025, 2030, and 2035, respectively. In the base case analysis, a likely population estimate was assumed, focusing on patients receiving at least 3 injections within a year, along with a reduction in administrations number based on data from the second and subsequent years. Under the primary scenario assumptions, the analysis projects an increasing capacity for additional patients within the drug programme as FAR is introduced. Specifically, the estimated number of additional patients that could be accommodated with the same healthcare resources is estimated to reach 2,115 in 2025, 5,103 in 2030, and 7,662 in 2035 (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eAdditional number of patients - results\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e\u003cp\u003eParameters\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2025\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2030\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2035\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"6\" rowspan=\"7\"\u003e\u003cp\u003eBase case scenario\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003ePopulation, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e60,292\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e75,258\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e92,000\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eAverage number of inj. per patient\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAFL, BRO, RAN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c6\" namest=\"c4\"\u003e\u003cp\u003e5.82\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c6\" namest=\"c4\"\u003e\u003cp\u003e4.98\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eNumber of inj. per population\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWithout FAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e350,611\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e437,640\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e535,000\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWith FAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e337,890\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e406,950\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e488,920\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDifference\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12,721\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e30,691\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e46,080\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e\u003cb\u003eAdditional number of patients, n\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003e2,115\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u003cb\u003e5,103\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cb\u003e7,662\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"6\" rowspan=\"7\"\u003e\u003cp\u003eMinimal scenario\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003ePopulation, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e54,619\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e61,597\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e67,221\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eAverage number of inj. per patient\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAFL, BRO, RAN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c6\" namest=\"c4\"\u003e\u003cp\u003e5.15\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c6\" namest=\"c4\"\u003e\u003cp\u003e4.42\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eNumber of inj. per population, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWithout FAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e281,357\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e317,299\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e346,269\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWith FAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e271,228\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e295,222\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e316,679\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDifference\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e10,128\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e22,077\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e29,591\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e\u003cb\u003eAdditional number of patients, n\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003e1,684\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u003cb\u003e3,671\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cb\u003e4,920\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"6\" rowspan=\"7\"\u003e\u003cp\u003eMaximal scenario\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003ePopulation, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e57,064\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e82,925\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e108,787\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eAverage number of inj. per patient\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAFL, BRO, RAN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c6\" namest=\"c4\"\u003e\u003cp\u003e6.87\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c6\" namest=\"c4\"\u003e\u003cp\u003e5.86\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eNumber of inj. per population, n\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWithout FAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e391,832\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e569,408\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e746,985\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eWith FAR\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e377,367\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e528,782\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e681,527\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eDifference\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e14,464\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e40,626\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e65,459\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e\u003cb\u003eAdditional number of patients, n\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003e2,405\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u003cb\u003e6,755\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cb\u003e10,885\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003cem\u003eAFL\u003c/em\u003e aflibercept 2 mg; \u003cem\u003eBRO\u003c/em\u003e brolucizumab; \u003cem\u003einj.\u003c/em\u003e injections; \u003cem\u003en\u003c/em\u003e number of items; \u003cem\u003eFAR\u003c/em\u003e faricimab; \u003cem\u003eRAN\u003c/em\u003e ranibizumab.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u0026hellip;\u0026hellip;Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e here\u0026hellip;\u0026hellip;\u0026hellip;\u003c/p\u003e\u003cp\u003eThis suggest that FAR has the potential to enhance programme efficiency over time, allowing a growing number of patients to access treatment for retinal diseases without requiring an expansion of healthcare funding or infrastructure.\u003c/p\u003e\u003cp\u003eIn the minimum scenario, the analysis projects that an additional 1,684 patients could be treated within the B.70 programme in 2025, increasing to 3,671 in 2030, and reaching 4,920 in 2035. This reflects a modest but steady growth in capacity to treat more patients with the same healthcare resources, as FAR reduces the frequency of required injections.\u003c/p\u003e\u003cp\u003eIn the maximum scenario, the projected increase in patient capacity is significantly higher, with an additional 2,405 patients in 2025, 6,755 in 2030, and 10,885 in 2035. This scenario demonstrates the potential impact of FAR in maximising resource efficiency and enabling more patients to receive treatment as the drug\u0026rsquo;s uptake grows over time.\u003c/p\u003e\u003cp\u003eMost individuals for whom services were reimbursed under the B.70 drug programme received them within a maximum of 6 months (99% of those on the waiting list), with approximately 3 out of 4 individuals receiving services within 1 month [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan additionalcitationids=\"CR31 CR32\" citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] (Supplemental Table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e, Supplemental Figure S2). Meanwhile, the number of people on waiting lists receiving services at ophthalmology outpatient centres increased by 88% in 2023 (374,000 patients) compared with 2019 (198,000 patients) [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan additionalcitationids=\"CR31 CR32\" citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] (Supplemental Table S2).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study provides a comprehensive analysis of the real-world administration rates of AFL, BRO, and RAN in the Polish healthcare system, assessing the potential impact of introducing FAR reimbursement on improving access to ophthalmic services. By presenting current usage patterns of reimbursed anti-VEGF treatments, this work provides valuable insights into the current demand and frequency of intravitreal injections. The analysis simulates how FAR, with its unique dual mechanism of action and longer lasting therapeutic effect, could reduce the number of injections required per patient. This reduction would have significant implications for healthcare resource allocation, as it could free up capacity within ophthalmology clinics, enabling a greater number of patients with retinal diseases, to access timely and effective treatment under the B.70 drug programme.\u003c/p\u003e\u003cp\u003eThe study projects the potential increase in patient capacity under different scenarios, demonstrating how FAR\u0026rsquo;s adoption could alleviate some of the pressure on Poland\u0026rsquo;s ophthalmology services. Given the expected rise in retinal disease prevalence due to an ageing population, this work emphasises the pivotal role that FAR could play in enhancing resource efficiency, optimising patient care, and addressing the mounting demand within the healthcare system, all without requiring additional financial or human resources. In this context, the results underscore the importance of FAR reimbursement as a strategy to improve access to advanced retinal disease therapies, ultimately contributing to better patient outcomes and healthcare system sustainability.\u003c/p\u003e\u003cp\u003eThe Polish Society of Ophthalmic Surgeons states that Poland offers world-class treatment for retinal diseases. The society highlights the importance of early diagnosis and prompt initiation of treatment, as delays can result in irreversible retinal changes. Effective treatment options are currently available, including anti-VEGF agents. The statement also acknowledges the ongoing development of new drugs, aiming at extending the intervals between injections, which would benefit both patients and the healthcare system [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThis context underscores the importance of timely access to advanced therapies and serves as a basis for discussing potential improvements and challenges in the management of retinal diseases within the Polish healthcare system.\u003c/p\u003e\u003cp\u003eSix months after introducing the public funding for FAR, its market share among anti-VEGF agents had reached 6% [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. This confirms the initial assumption of capturing 40% of new patients and those switching treatment. By the end of the first year, it is expected that 11% will be using FAR.\u003c/p\u003e\u003cp\u003eDespite the increase in services, there is still an unmet need for access to ophthalmologists in Poland. This shortage could delay the diagnosis of retinal diseases such as nAMD and DME, potentially increasing the demand for treatment within the B.70 drug programme. As the population ages, the prevalence of these conditions is likely to increase, highlighting the need for greater access to both ophthalmic consultations and drug programmes. The situation highlights the importance of addressing the resource constraints in eye care to meet the anticipated demand and ensure timely interventions for retinal disease management.\u003c/p\u003e\u003cp\u003eIn 2023, more than \u0026euro;100\u0026nbsp;million was allocated from public funds for the treatment of patients with retinal diseases under the B.70 drug programme, with more than 60% of the total cost attributed to medical services [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Reducing the number of drug administrations, while maintaining the efficacy and safety of the treatment, will optimise available resources, including financial and human resources, enabling more efficient allocation of funds and personnel. This approach would not only reduce the financial burden on the healthcare system but also ensure that resources are directed towards providing comprehensive and high-quality care for patients with retinal diseases, ultimately improving patient outcomes.\u003c/p\u003e\u003cp\u003eA 2014 systematic review [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e] provides a comprehensive analysis of the global prevalence of age-related macular degeneration. The review includes projections for the disease burden up to the year 2040, highlighting significant trends in the increasing prevalence of nAMD worldwide. Europe experiences the highest prevalence of nAMD, with a rate of 12.33%, which is significantly higher than the global average of 8.69%, as revealed by a meta-analysis of the available data. According to the review\u0026rsquo;s projections, 288\u0026nbsp;million people worldwide are expected to be affected by AMD by 2040, representing an almost 50% increase compared to 2020. Given that a neovascular form accounts for approximately 15\u0026ndash;20% of all AMD cases [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e], this would translate into 43\u0026ndash;58\u0026nbsp;million individuals globally living with nAMD by 2040. These figures align with those obtained in our work, emphasising the growing challenge posed by the increasing number of patients with nAMD.\u003c/p\u003e\u003cp\u003e When reviewing the impact of faricimab reimbursement on healthcare system accessibility for retinal disease treatment in Poland, a significant gap in the literature becomes apparent: there are limited studies assessing the multidimensional implications of reimbursement policies. Most of the available studies focus on the current patient costs and disease burden, without evaluating the broader systemic impacts of treatment innovations.\u003c/p\u003e\u003cp\u003ePatients with nAMD and those with DME represent a significant economic burden on the healthcare system. High treatment costs, associated with frequent intravitreal injections, numerous ophthalmology visits, and diagnostic procedures, drive a substantial increase in healthcare expenditure. Findings from a nationwide French study [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e] on the real-life management of nAMD show that the total treatment costs for nAMD patients are twice as high as for control patients (those without nAMD), primarily due to the higher number of medical visits and ophthalmic procedures, as well as increased transport costs. The results of the latest study [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e] suggest that the 3-year treatment costs for patients with DME, as estimated for matched cohorts, can be nearly twice as high as those for patients without DME. Patients with DME require significantly more outpatient and inpatient visits than patients with diabetes mellitus without DME [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOptimising nAMD and DME management, particularly by reducing the frequency of drug administrations while preserving treatment efficacy and safety, could significantly decrease demand for ophthalmology services and reduce associated treatment costs. Introducing therapies with longer dosing intervals and predictable efficacy could not only relieve pressure on healthcare resources but also enhance patient quality of life and ensure a more effective use of medical services [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. Similar conclusions were reached in a recent Spanish study [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e], which suggests that managing of nAMD patients significantly impacts the healthcare system burden, which is expected to increase as the population ages and the number of nAMD patients rises. Both DME and nAMD impose a significant economic burden, as highlighted by a Slovak study [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e], which estimated the annual costs for patients with DME to be \u0026euro;45\u0026nbsp;million, compared to \u0026euro;106\u0026nbsp;million for those with nAMD. Therefore, more effective therapies with longer-lasting effects could be beneficial in extending treatment intervals, thereby reducing the burden on patients and their caregivers and improving the utilisation of healthcare resources.\u003c/p\u003e\u003cp\u003eThis context highlights the necessity for studies that explore the potential multidimensional impacts of reimbursement for extended-dosing treatments such as faricimab, as they could provide valuable insights into improving healthcare accessibility for retinal disease patients not only in Poland, but also worldwide.\u003c/p\u003e\u003cp\u003eUncertainty in the data may also stem from estimating the number of patients in the drug programme. As a forecast, this is based on assumptions and projections derived from current trends and available data. However, these projections are inherently subject to change due to various factors, such as changes in patient demographics, disease prevalence, treatment patterns, or healthcare policies. What is certain is that the number of patients will continue to rise as the population ages. The real question, however, is how fast this growth will occur and whether the public payer will be able to ensure that all needed patients have access to necessary treatments. These uncertainties highlight the challenges of making accurate long-term projections, so any estimates should therefore be treated with caution.\u003c/p\u003e\u003cp\u003eA 2 mg dose of AFL was used to estimate the number of doses, as it was the only reimbursed option until the end of 2023 (8 mg dose has been reimbursed since October 2024). Notably, the 8 mg dose has a dosing frequency similar to FAR.\u003c/p\u003e\u003cp\u003eA limitation of the analysis is the assumption of fixed costs from 2024 throughout the considered time horizon. With FAR introduction into the reimbursement system is expected to further reduce the average cost per patient in the coming years. However, the medical service cost is also expected to increase due to factors such as inflation, rising healthcare salaries, and the growing fixed costs for healthcare providers.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThe analysis of data on the implementation of the nAMD and DME treatment programme in Poland indicates significant untapped potential for the public payer in terms of optimising treatment organisation and enhancing patient access to care. Despite the large number of potential patients, only a small proportion receive treatment [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. The introduction of FAR reimbursement is expected to significantly improve long-term access to ophthalmic services in Poland, particularly within the retinal disease programme, by reducing the frequency of required injections. This shift underscores the potential for greater resource efficiency, enabling more patients to benefit from the programme without the need of extra funding or healthcare resources. Such improvements are critical in the context of pressing public health challenges, including ageing population, rising prevalence of nAMD and DME, and a stagnant yet insufficient number of ophthalmologists.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u0026nbsp;\u003cem\u003eAFL\u003c/em\u003e aflibercept; \u003cem\u003eBEV\u003c/em\u003e bevacizumab; \u003cem\u003eBRO\u003c/em\u003e brolucizumab; \u003cem\u003eDEX\u003c/em\u003e dexamethasone; \u003cem\u003eDME\u003c/em\u003e diabetic macular edema; \u003cem\u003eETDRS\u003c/em\u003e Early Treatment of Diabetic Retinopathy Study; \u003cem\u003eEMA\u003c/em\u003e European Medicines Agency; \u003cem\u003eFAR\u003c/em\u003e faricimab; \u003cem\u003einj.\u003c/em\u003e injection; \u003cem\u003emax\u003c/em\u003e maximum; \u003cem\u003emin\u003c/em\u003e minimum; \u003cem\u003en\u003c/em\u003e number of patients\u003cem\u003e; nAMD\u003c/em\u003e neovascular age-related macular degeneration; \u003cem\u003eOCT\u003c/em\u003e optical coherence tomography; \u003cem\u003eRAN\u003c/em\u003e ranibizumab; \u003cem\u003eVEGF\u003c/em\u003e vascular endothelial growth factor.\u0026nbsp;\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate: Not applicable\u003c/p\u003e\n\u003cp\u003eConsent for publication: Not applicable\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials: The datasets analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003eCompeting interests: AM is employed by the sponsoring company; however, his role in the study was independent and based solely on scientific and methodological standards.\u003c/p\u003e\n\u003cp\u003eFunding: This study received the financial support from Roche Polska, Poland.\u003c/p\u003e\n\u003cp\u003eAuthors\u0026apos; contributions: All authors contributed equally to the design of the article and the interpretation of the data. JK performed the statistical analysis. JK, JA, and AM drafted the manuscript, while MS, MDT, and RR provided revisions. JA ensured administrative and technical support. All authors reviewed and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eAcknowledgements: Not applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eNasimi S, Nasimi N, Grauslund J, Vergmann AS, Subhi Y. Real-World Efficacy of Intravitreal Faricimab for Diabetic Macular Edema: A Systematic Review. J Pers Med. 2024 Aug 28;14(9):913; https://doi.org/10.3390/jpm14090913\u003c/li\u003e\n\u003cli\u003eBantounou MA, Elsheikh M, Ijasan A, et al. Real-world experience of intravitreal faricimab injection in previously treated neovascular age-related macular degeneration eyes: a case series. BMC Ophthalmol. 2025;25:117; https://doi.org/10.1186/s12886-025-03953-9 \u003c/li\u003e\n\u003cli\u003eJoussen AM, Ricci F, Paris LP, et al. 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Ophthalmol Sci. 2021 Dec 30;2(1):100111; https://doi.org/10.1016/j.xops.2021.100111.\u003c/li\u003e\n\u003cli\u003eKhanani AM, Guymer RH, Basu K, et al. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. https://doi.org/10.1016/j.xops.2021.100076.\u003c/li\u003e\n\u003cli\u003eWykoff CC, Abreu F, Adamis AP, et al. YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755; https://doi.org/10.1016/S0140-6736(22)00018-6.\u003c/li\u003e\n\u003cli\u003eHeier JS, Khanani AM, Quezada Ruiz C, et al. TENAYA and LUCERNE Investigators. 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Exchange rates. https://nbp.pl/en/statistic-and-financial-reporting/rates/ Accessed November 12, 2024.\u003c/li\u003e\n\u003cli\u003eStatistics Poland. Statistical, Population projection 2023\u0026ndash;2060. https://stat.gov.pl/obszary-tematyczne/ludnosc/prognoza-ludnosci/prognoza-ludnosci-na-lata-2023-2060,11,1.html Accessed October 08, 2024.\u003c/li\u003e\n\u003cli\u003eGujski MA, Raciborski F, et al. Health Care Institute: Report Eye diseases - a health and social problem and a civilization challenge in the face of an aging population. Warsaw: Instytut Ochrony Zdrowia; 2016. p. 101-115. ISBN 978-83-944863-2-7.\u003c/li\u003e\n\u003cli\u003eMekjavić PJ, Balciuniene VJ, Ceklic L, et al. The Burden of Macular Diseases in Central and Eastern Europe - Implications for Healthcare Systems. Value Health Reg Issues. 2019;19:1-6; \u003cu\u003ehttps://doi.org/10.1016/j.vhri.2018.11.002.\u003c/u\u003e\u003c/li\u003e\n\u003cli\u003e\u0026quot;Retina AMD Polska\u0026quot; Portal, Roche. Report: nAMD - The path from diagnosis to treatment. 2023. Available from: http://retinaamd.org.pl/wp-content/uploads/2023/03/Retina_Raport-FIN.pdf\u003cu\u003e. \u003c/u\u003eAccessed October 22, 2024.\u003c/li\u003e\n\u003cli\u003eMap of health needs, Epidemiological forecast. https://basiw.mz.gov.pl/mapy-informacje/mapa-2022-2026/analizy/prognoza-epidemiologiczna/ Accessed October 22, 2024.\u003c/li\u003e\n\u003cli\u003eReport No: OT.4221.41.2021. Bevacizumab for the indication: treatment of diabetic macular edema (DME) (ICD10: H36.0). https://bipold.aotm.gov.pl/assets/files/zlecenia_mz/2021/055/RPT/55_OT_4221_41_2021_Bewacyzumab_DME_BIP_REOPTR.pdf Accessed October 23, 2024.\u003c/li\u003e\n\u003cli\u003eMinassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England, Br J Ophthalmol. 2012 Mar;96(3):345-9; \u003cu\u003ehttps://doi.org/10.1136/bjo.2011.204040.\u003c/u\u003e\u003c/li\u003e\n\u003cli\u003eMap of Health Needs, Drug Programmes. https://basiw.mz.gov.pl/en/maps-of-health-needs/map-of-health-needs-for-the-period-2022-2026/analyses/drug-programmes/ Accessed October 08, 2024.\u003c/li\u003e\n\u003cli\u003eNHF Council Resolutions. Resolution No. 29/2024/IV dated October 17, 2024, regarding the adoption of the periodic performance report of the National Health Fund for the second quarter of 2024. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-292024iv,6679.html Accessed October 25, 2024.\u003c/li\u003e\n\u003cli\u003eAgency for Health Technology Assessment and Tariff System in Poland. 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National Health Fund. https://baw.nfz.gov.pl/NFZ/document/43336/Zarzadzenie-76_2024_DGL Accessed October 25, 2024.\u003c/li\u003e\n\u003cli\u003eOrder No. 175/2023/DGL of the President of the NHF of 30 November 2023 order on determining terms of concluding and performing contracts for inpatient treatment under drug programmes. National Health Fund. https://baw.nfz.gov.pl/NFZ/document/2095/Zarzadzenie-175_2023_DGL Accessed October 25, 2024.\u003c/li\u003e\n\u003cli\u003eInformation on Concluded Contracts. https://aplikacje.nfz.gov.pl/umowy/Provider/Search?Branch=01 Accessed October 18, 2024.\u003c/li\u003e\n\u003cli\u003eNHF Council Resolutions. Resolution No. 6/2020/III dated March 20, 2020, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2019. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-62020iii,6527.html Accessed October 21, 2024.\u003c/li\u003e\n\u003cli\u003eNHF Council Resolutions. Resolution No. 5/2021/IV dated March 12, 2021, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2020. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-52021iv,6555.html Accessed October 21, 2024.\u003c/li\u003e\n\u003cli\u003eNHF Council Resolutions. Resolution No. 3/2022/IV dated March 16, 2022, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2021. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-32022iv,6592.html Accessed October 21, 2024.\u003c/li\u003e\n\u003cli\u003eNHF Council Resolutions. Resolution No. 8/2023/IV dated March 20, 2024, regarding the adoption of the periodic performance report of the National Health Fund for the fourth quarter of 2022. https://www.nfz.gov.pl/zarzadzenia-prezesa/uchwaly-rady-nfz/uchwala-nr-82023iv,6627.html Accessed October 21, 2024.\u003c/li\u003e\n\u003cli\u003eWorld-Class Treatment of Retinal Diseases. Practical Medicine Online Portal. https://www.mp.pl/pacjent/okulistyka/aktualnosci/319677,leczenie-chorob-siatkowki-na-swiatowym-poziomie Accessed October 31, 2024.\u003c/li\u003e\n\u003cli\u003eWong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. \u003cu\u003ehttps://doi.org/10.1016/S2214-109X(13)70145-1. \u003c/u\u003e\u003c/li\u003e\n\u003cli\u003eChaudhuri M, Hassan Y, Bakka Vemana PPS, Bellary Pattanashetty MS, Abdin ZU, Siddiqui HF. Age-related macular degeneration: an exponentially emerging imminent threat of visual impairment and irreversible blindness. Cureus. 15(5):e39624. \u003cu\u003ehttps://doi.org/10.7759/cureus.39624\u003c/u\u003e\u003c/li\u003e\n\u003cli\u003eKorobelnik JF, Delcourt C, Creuzot-Garcher C, et al. Real-life management of neovascular age-related macular degeneration (nAMD) in France: a nationwide observational study using retrospective claims data. J Med Econ. 2021 Jan-Dec;24(1):1087-1097. \u003cu\u003ehttps://doi.org/10.1080/13696998.2021.1971416.\u003c/u\u003e\u003c/li\u003e\n\u003cli\u003eChoi K, Park SJ, Yoon H, et al. Patient-Centered Economic Burden of Diabetic Macular Edema: Retrospective Cohort Study. JMIR Public Health Surveill. 2024 Oct 8;10:e56741. https://doi.org/10.2196/56741\u003c/li\u003e\n\u003cli\u003ePina Mar\u0026iacute;n B, Gajate Paniagua NM, G\u0026oacute;mez-Bald\u0026oacute; L, Gallego-Pinazo R. Burden of disease assessment in patients with neovascular age-related macular degeneration in Spain: Results of the AMD-MANAGE study. Eur J Ophthalmol. 2022 Jan;32(1):385-394. https://doi.org/10.1177/11206721211001716. \u003c/li\u003e\n\u003cli\u003eJanco L, Stefanickova J, Busanyova B, et al. Economic burden of age-related macular degeneration and diabetic macular edema in Slovakia: a cost-of-illness analysis. Bratisl Med J. 2025;126:544\u0026ndash;51. https://doi.org/10.1007/s44411-025-00140-6\u003c/li\u003e\n\u003cli\u003eSeweryn M, Leszczyńska A, Teper S. Potential in the treatment of neovascular Age-related Macular Degeneration and Diabetic Macular Edema in Poland. -population needs and access to therapy. J Health Policy Outcomes Res. 2024, 2 https://doi.org/10.7365/JHPOR.2024.2.1\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Diabetic macular edema, neovascular age-related macular degeneration, decreasing injection frequency, faricimab, vascular endothelial growth factor-A, Poland, public health","lastPublishedDoi":"10.21203/rs.3.rs-7299149/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7299149/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eThis study aimed to evaluate the impact of introducing faricimab into a publicly funded drug programme for retinal diseases, focusing particularly on reducing treatment frequency and optimising resources. Faricimab, a bispecific antibody targeting angiopoietin-2 and VEGF-A, offers a dual mechanism for managing nAMD and DME, both leading causes of vision loss.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThe analysis included forecasting patient treatment trends, estimating the potential market share of faricimab, and simulating drug administration frequencies. A Monte Carlo simulation was conducted to model the impact of faricimab on reducing injection frequency. Scenarios with variable patient numbers and administration rates were explored, covering the years 2025, 2030, and 2035, to assess potential efficiencies in healthcare resources use and the capacity to treat additional patients.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eResults indicated that faricimab could reduce injection frequency by approximately 15%, freeing up resources within the healthcare system. Under the primary scenario, faricimab introduction could enable an additional 2,115 patients to be treated in 2025, rising to 7,662 by 2035 without additional resources. In the minimum scenario, the capacity increased by 4,920 patients by 2035, while the maximum scenario saw an increase of 10,885 patients.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eThe introduction of faricimab is expected to improve access to ophthalmic treatments, especially within the drug programme for retinal diseases, by decreasing injection frequency and enhancing resource efficiency. Given Poland\u0026rsquo;s ageing population and the rising prevalence of nAMD and DME, which represent significant public health challenges, faricimab adoption could alleviate pressures on healthcare infrastructure, ultimately supporting better patient outcomes and overcoming current limitations in access to ophthalmic services.\u003c/p\u003e","manuscriptTitle":"Multidimensional Evaluation of the Potential Impact of Faricimab Availability on Healthcare System Accessibility for Retinal Disease Treatment in Poland","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-17 14:15:14","doi":"10.21203/rs.3.rs-7299149/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-01-13T17:50:14+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-12T14:53:34+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"49039292302958043955543867831649387772","date":"2025-12-30T06:10:41+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"227998379019852357685147539032888825254","date":"2025-11-25T21:26:11+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-02T15:31:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"19439662167535120215740276868103409840","date":"2025-09-23T05:15:45+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"311503730758891003488050196361060764929","date":"2025-09-14T14:27:32+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-08T13:28:17+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-08-06T07:39:29+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-06T00:58:40+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-06T00:58:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-08-05T09:40:49+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"60018ef7-aed1-41e5-9957-30d75406dff3","owner":[],"postedDate":"August 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T16:00:16+00:00","versionOfRecord":{"articleIdentity":"rs-7299149","link":"https://doi.org/10.1186/s12913-026-14231-9","journal":{"identity":"bmc-health-services-research","isVorOnly":false,"title":"BMC Health Services Research"},"publishedOn":"2026-02-23 15:57:06","publishedOnDateReadable":"February 23rd, 2026"},"versionCreatedAt":"2025-08-17 14:15:14","video":"","vorDoi":"10.1186/s12913-026-14231-9","vorDoiUrl":"https://doi.org/10.1186/s12913-026-14231-9","workflowStages":[]},"version":"v1","identity":"rs-7299149","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7299149","identity":"rs-7299149","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}