Cost-effectiveness of the anti-vascular endothelial growth factor intravitreal injection and panretinal photocoagulation for patients with proliferative diabetic retinopathy in South Korea

doi:10.21203/rs.3.rs-2717540/v1

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Research Article

Cost-effectiveness of the anti-vascular endothelial growth factor intravitreal injection and panretinal photocoagulation for patients with proliferative diabetic retinopathy in South Korea

https://doi.org/10.21203/rs.3.rs-2717540/v1

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published 11 Dec, 2023

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Background: We determined the cost-effectiveness of the anti-vascular endothelial growth factor (VEGF) intravitreal injection versus panretinal photocoagulation (PRP) for patients with proliferative diabetic retinopathy (PDR) in South Korea.

Methods: We simulated four treatment strategies using PRP and the anti-VEGF injection by constructing a Markov model for a hypothetical cohort of 50-year-old PDR patients: (1) PRP only; (2) anti-VEGF injection only; (3) PRP first; and (4) anti-VEGF injection first.

Results: In this cost-effectiveness analysis, compared with only-PRP, the incremental cost-effectiveness ratiowas $95,456 per quality-adjusted life-year (QALY) for PRP first, $34,375 per QALY for anti-VEGF injection first, and $33,405 per QALY for anti-VEGF injection only from a healthcare perspective. From the societal and payer perspective, strategy (2) was more cost-saving and effective than (1). In the probabilistic sensitivity analysis, only-PRP was cost-effective up to the willingness-to-pay (WTP) of about $42,000, while anti-VEGF injection only was cost-effective from a healthcare perspective. From the societal and payer perspectives, regardless of the value of WTP, anti-VEGF injection only was the most cost-effective strategy.

Conclusion: Our results on the cost-effectiveness of the anti-VEGF injection for PDR, alone or in combination with PRP treatment, can be used as important evidence when making medical service decisions.

anti-VEGF injection

cost-effectiveness analysis

panretinal photocoagulation

proliferative diabetic retinopathy

South Korea

Diabetic retinopathy (DR) is a leading cause of blindness worldwide [1]. Early detection and proper treatment can prevent vision loss from DR; thus, patients with diabetes should have regular follow-up with an ophthalmologist [2]. According to a systemic meta-analysis, the global prevalence of DR is about 28% in women and 25% in men [3]. With the prevalence of diabetes mellitus expected to rise from 463 million in 2019 to 700 million in 2045, the prevalence of DR is estimated to reach 160 million, and vision-threatening DR, in particular, 44 million in that period [4]. Among patients with DR, proliferative DR (PDR) carries a high risk of vision loss, even blindness. Hence, most treatment for DR is focused on treating or preventing PDR.

Panretinal photocoagulation (PRP) and the anti-vascular endothelial growth factor (VEGF) intravitreal injection are mainly used to prevent blindness due to DR [5]. Use of the anti-VEGF injection in DR has increased significantly [6–9]. However, both treatments have sharply contrasting pros and cons, which makes it difficult to make medical service choices [10–12]. While PRP has certain advantages—such as a fairly low cost, PDR treatment being covered by South Korea’s National Health Insurance Service (NHIS), and more long-term effects—PRP also has drawbacks, such as the visual field defect via peripheral retina atrophy after PRP [13–14], and diabetic macular edema (DME), which may worsen visual acuity [15, 16]. The anti-VEGF injection does almost no harm to the retinal tissue, such as visual field damage and DME [7]. However, the economic burden of the anti-VEGF injection is heavy because the price for a single injection is expensive and not covered for PDR treatment in South Korea [17]. Moreover, a the treatment effect is relatively short-term, the anti-VEGF injection must be repeated [18]. This inhibits the cost-effectiveness of the anti-VEGF injection, although this cost-effectiveness can vary according to the type of anti-VEGF agent involved [19].

As the pros and cons of the two approaches are clearly contrasting, the treatment is chosen according to the patient’s preference or the doctor’s choice in actual clinical practice. As such, it is necessary to provide evidence for medical service decisions regarding the economic evaluation of PRP and the anti-VEGF injection. We assess the treatment of PDR on an economic basis, including PRP and the anti-VEGF injection, using cost-effectiveness analysis.

Supplementary Table 1 outlines our analysis.

Target population

The target population consisted of 50-year-old patients with PDR owing to the rising prevalence of DR in adults aged ≥ 50 years.

Treatment strategies

We developed four strategies for the economic evaluation: (1) PRP only: using only PRP, covered by South Korea’s National Health Insurance Service (NHIS); (2) anti-VEGF injection only: using the anti-VEGF injection only; (3) PRP first: using PRP first, and if the treatment does not work, then using the anti-VEGF injection; and (4) anti-VEGF injection first: using the anti-VEGF injection first, and if the treatment does not work, then using PRP. Although more than four treatment patterns are used in actual clinical practice, it was not feasible to model them as they are, and we set four strategies as the treatment approach. We compared the PRP-only strategy to the other three other strategies. In clinical practice, it is common to alternately use PRP and the anti-VEGF injection according to the patient’s condition (rather than using either) for PDR. However, since only PRP is covered under the NHIS for PDR, we used this strategy to compare with other strategies. Among all of them, we employed the three anti-VEGF injections as the loading dose.

Model structure

For the economic evaluation, we built a Markov model and performed cohort simulation (Fig. 1). The Markov states consisted of non-proliferative DR (NPDR), PDR, DME, severe visual loss (SVL), and death based on the natural history of the disease. In the NPDR state, regular follow-up is performed. In the PDR state, PRP or the anti-VEGF injection is used. In the DME state, the anti-VEGF injection is used. SVL was defined as less than 0.1 visual acuity.

Response to treatment may be different in either eye, but if this is reflected in the model, the model may become overly complicated. We used the monocular model, which creates the model based on the eye with the better eyesight, as in prior studies [20].As a major side effect of treatment for PDR, we modeled the DME and permanent peripheral visual field loss after PRP, and endophthalmitis after the anti-VEGF injection.

Model assumptions

We assumed that the anti-VEGF injection would be given twice a year in the SVL state to avoid exacerbating the condition, leading to non-light perception. We calculated the treatment continuity rate in the SVL state from the claims data and applied it to the model. We defined treatment continuation in the SVL as a case of outpatient treatment at least twice a year. We assumed that patients in the SVL state would receive care for three hours a day for daily living assistance. We did not apply care costs from the age of 90 since we assumed that people aged 90 and above with good vision also needed assistance in daily living. Since the target population was DR patients with diabetes, we applied the risk ratio (RR) of death from diabetes to the mortality rate of the general population.

Cohort simulation

Our model involves a hypothetical cohort of PDR patients aged 50 years. In the cohort simulation, patients start with the PDR state. If the treatment is successful and the angiogenesis is fully annihilated in PDR, they move on to the NPDR state. If neovascularization recurs, they move on to the PDR state. The patients in the PDR and NPDR states can shift to the DME state. Patients in any state can remain in that state or move to the death state. The Markov state changes via transition probabilities between the states (Fig. 1). Cohort simulation is terminated when the patients reach 100 years of age.

Model parameters

Treatment-related probability

We calculated the treatment-related probability of PRP and the anti-VEGF injection using anonymized data from the Clinical Data Warehouse (CDW) of South Korea’s Catholic Medical Center. The Catholic Medical Center began operating the CDW to harness clinical data from six affiliated hospitals in 2019. We utilized data relating to patients diagnosed with DR from January 1, 2012, to April 1, 2019. For probabilities that we could not compute using the CDW, we reviewed previous studies or the NHIS claims data.

Cost

Using the NHIS claims data, we calculated the annual cost for each Markov state and the treatment cost of the PRP and the anti-VEGF injection per episode (Supplementary Table 2). We identified cost items according to various perspectives. From the payer perspective, only medical expenses covered by the NHIS were included. From the healthcare system perspective, medical costs incurred within the healthcare system were included (i.e., medical expenses covered and not covered by the NHIS). From the societal perspective, medical, transportation, time, and care costs were included. We computed covered medical expenses by analyzing claims data from the NHIS; estimated non-covered medical costs by calculating the non-coverage rate from South Korea’s Health Insurance Patient Medical Expenses Survey; determined transportation costs based on 2018 data from the annual South Korea Medical Panel Survey (2008–2018) (Version 1.7); established the time costs using the hourly wage for outpatients and the daily wage for hospitalized patients from South Korea’s Ministry of Employment and Labor; and used the employment rate from the country’s Economic Activity Population Survey. Costs are expressed in 2020 US dollars (USD). If no data for 2020 were available, we employed the data for the nearest year, an relied on the consumer price index to adjust the costs for 2020.

Utility

We assessed utility using the EuroQol five-dimensions with a 3-level questionnaire (EQ-5D-3L), a generic health-related quality of life (HRQoL) measurement tool [21]. Data on HRQoL for DR patients are scarce in South Korea. We performed a survey to evaluate the HRQoL for 300 DR patients at St. Vincent’s Hospital, run by the Catholic University of South Korea. Because no previous study had been conducted on the HRQoL of PDR patients with peripheral visual field defect (pVFD) in South Korea, we assumed that utility would decrease due to permanent pVFD, which we set to 0.01 based on expert opinion.

Analysis

We computed the incremental cost-effectiveness ratio (ICER) as a final outcome of the model using quality-adjusted life years (QALYs) to represent effectiveness. Given the uncertainty of the parameters, we performed deterministic and probabilistic sensitivity analyses (Supplementary Table 2). For deterministic sensitivity analysis, we carried out one-way sensitivity analysis for each parameter in the model; the results are presented in tornado diagrams, which comprise an integrated set of one-way sensitivity analyses. Probabilistic sensitivity analysis caused the parameters to vary simultaneously based on probability distributions with 10,000 re-samplings. The results are presented in a cost-effectiveness acceptability curve (CEAC). We conducted our analyses using TreeAge Pro Healthcare 2020 (TreeAge software, MA, US).

Base case results

From the healthcare system perspective, the expected cost of the PRP-only strategy for one patient was $9,153; for the PRP-first strategy, it was $10,894; for the anti-VEGF injection-first strategy, it was $12,834; and for the anti-VEGF injection-only strategy, it was $15,446. Compared with the PRP-only strategy, there was an additional cost of $1,741 for the PRP-first strategy; $3,681 for the anti-VEGF injection-first strategy; and $6,293 for the anti-VEGF injection-only strategy. The effectiveness was 13.07 QALYs for the PRP only strategy, 13.09 QALYs for the PRP first strategy, 13.18 QALYs for the anti-VEGF injection first strategy, and 13.26 QALYs for the anti-VEGF injection only strategy. Compared with the PRP only strategy, a patient who received the PRP first strategy gained 0.02 more QALYs, a patient who received the anti-VEGF injection first strategy gained 0.11 more QALYs, and a patient who received the anti-VEGF injection only strategy gained 0.19 more QALYs. The ICER of the PRP first strategy over the PRP only strategy was $95,456 per QALY; for the anti-VEGF injection first strategy, it was $34,375 per QALY; and for the anti-VEGF injection only strategy, it was $33,405 per QALY. Hence, during a lifetime horizon, the anti-VEGF injection only strategy was dominant. As the threshold ICER of $24,400 per QALY²²—which has been suggested as willingness-to-pay (WTP) per one QALY gain in South Korea—the anti-VEGF injection only strategy was not cost-effective.

From the societal and payer perspectives, the anti-VEGF injection only, the anti-VEGF injection first, and the PRP-first strategies were dominant methods to save costs and increase effectiveness compared with the PRP-only strategy. The anti-VEGF injection-only strategy was the least costly and the most effective compared with the other strategies (Table 1).

Table 1

Cost-effectiveness results from base case
Strategy	Cost ($)	Incremental Cost ($)	Effectiveness (QALY)	Incremental Effectiveness (QALY)	Incremental cost-effectiveness ratio ($/QALY)
Healthcare system perspective
PRP only	9,153		13.07
PRP first	10,894	1,741	13.09	0.02	95,456
Anti-VEGF first	12,834	3,681	13.18	0.11	34,375
Anti-VEGF only	15,446	6,293	13.26	0.19	33,405
Societal perspective
PRP only	85,188		13.07
PRP first	81,536	-3,653	13.09	0.02	Cost-saving
Anti-VEGF first	76,737	-8,451	13.18	0.11	Cost-saving
Anti-VEGF only	70,366	-14,823	13.26	0.19	Cost-saving
Payer perspective
PRP only	5,132		13.07
PRP first	4,477	-656	13.09	0.02	Cost-saving
Anti-VEGF first	4,053	-1,079	13.18	0.11	Cost-saving
Anti-VEGF only	3,361	-1,772	13.26	0.19	Cost-saving
QALY: quality-adjusted life year; PRP: panretinal photocoagulation; anti-VEGF: anti-vascular endothelial growth factor

Sensitivity analysis

In the sensitivity analysis, we compared the anti-VEGF injection-only strategy versus the PRP-only strategy from the healthcare perspective. We conducted one-way sensitivity analysis for the anti-VEGF injection-only strategy, which had the smallest ICER compared with the PRP-only strategy. The ICER of the anti-VEGF injection-only strategy over the PRP-only strategy fell below the threshold ICER of $24,400 per QALY when altering the following parameters: increased effectiveness of the anti-VEGF injection compared with PRP; decreased recurrence of PDR after receiving the anti-VEGF injection compared with PRP; decreased utility loss due to pVFD after PRP; decreased SVL state utility; decreased cost of the anti-VEGF injection for PDR per episode; and increased NPDR state utility. The tornado diagram between the PRP only strategy and the anti-VEGF injection only strategy is shown in Fig. 2.

In the probabilistic sensitivity analysis from the healthcare perspective, the PRP-only strategy was most likely to be cost-effective in the range of up to about $42,000 in WTP, and the anti-VEGF injection-only strategy was most likely to be cost-effective in the WTP thereafter (Fig. 3). In the probabilistic sensitivity analysis from the societal and payer perspectives, regardless of the value of WTP, the anti-VEGF injection-only strategy was the most cost-effective strategy (Fig. 4 and Fig. 5).

We performed an economic evaluation of the anti-VEGF injection and PRP for treatment of PDR through cost-effectiveness analysis using Markov modeling. From the healthcare system perspective, compared with the PRP-only strategy, the ICER of the anti-VEGF injection-only strategy was $33,405 per QALY. The ICER of the anti-VEGF-first strategy was $34,375 per QALY compared with the PRP-only strategy. In the probabilistic sensitivity analysis, the PRP-only strategy was cost-effective up to the WTP of about $42,000, while the anti-VEGF injection-only strategy was cost-effective thereafter. From the societal and payer perspectives, the anti-VEGF injection-only, the anti-VEGF injection-first, and the PRP first strategies (compared with the PRP-only strategy) were cost-saving methods, while the anti-VEGF injection-only strategy was the least costly and the most effective approach compared with the other strategies. In the probabilistic sensitivity analysis, regardless of the value of WTP, the anti-VEGF injection only strategy was the most cost-effective technique.

Anti-VEGF injection treatment showed a cost-saving effect from the societal and payer perspectives owing to the following reasons. The medical cost for PDR was more than twice the cost of NPDR ($348 for PDR versus $160 for NPDR). When DME occurred, the medical cost exceeded $1,700. Most patients in the anti-VEGF treatment group remained in the NPDR state, whereas many patients in the PRP treatment group progressed to the SVL state. This indicates that anti-VEGF treatment reduces the severity of DR, suppresses progression to the SVL state, and has the advantage of preventing DME. Hence, although anti-VEGF treatment is more expensive, the cost-saving effect of reducing the severity of DR and preventing DME in PDR treatment is much greater. From the societal perspective, cost reduction effects (including time, transportation, and care costs) are also added. Anti-VEGF treatment is not cost-effective from the healthcare system perspective owing to the high cost of non-covered anti-VEGF injection.

In a previous study, Hutton et al. performed a cost-effectiveness analysis for PDR treatment between PRP and the ranibizumab injection based on the clinical trial of Protocol S by DRCR.net [20]. The ICER of the ranibizumab injection to PRP for PDR with DME was $55,568 per QALY, whereas the ICER for PDR without DME was $662,978 per QALY. The difference between our study and Hutton’s is that Hutton built a PDR treatment model that depends on the presence or absence of DME, but we used Markov modeling in which we applied the occurrence of DME for every year. Another difference is that the ICER in our study is lower than the one in Hutton’s. One reason could be that our low ICER may be due to the lower medical costs of South Korea than those found in the US [23–26]. Hutton indicated that if the price of ranibizumab (which has the greatest effect on ICER) fell from $1,916 to $900, ranibizumab would become more cost-saving than the combined treatment of PRP and ranibizumab in patients with DME. However, the cost of anti-VEGF treatment in South Korea does not exceed $900; in this backdrop, our conclusion that the anti-VEGF strategy is cost-saving may be reasonable.

In actual clinical practice, a combination of PRP and the anti-VEGF injection is frequently used to treat PDR, and the use of either PRP or the anti-VEGF injection is rare [27]. If a frequent change in treatment between PRP and the anti-VEGF injection were applied to the Markov modeling, the model would become overly complicated, creating challenged in interpreting the results. When interpreting the results of the economic evaluation, it is difficult to conclude that any one of the four strategies is dominant and cost-effective. Thus, we condensed the numerous treatment options into four treatment strategies.

Many studies have attempted to measure HRQoL using the EQ-5D in patients with eye diseases, but the EQ-5D may be less sensitive for this subset of the population [28–30]. In our study, the HRQoL of patients with blindness was not significantly different from that of other health states in the Markov model. This may be due to the EQ-5D’s lack of sensitivity to eye disease, or it may be due to the patient’s adaptation to blindness. A recent study, which reported the EQ-5D’s utility using data from the South Korea National Health and Nutrition Examination Survey (2008–2012), found that the utility of severe visual impairment was 0.894 [31]. We also assessed the HRQoL of DR patients based on the National Eye Institute Visual Function Questionnaire, which contains 25 items (NEI-VFQ-25) [32]. We found it to be significantly lower in the blindness state than in other health states (data not shown here). Since the EQ-5D does not sensitively reflect the HRQoL of DR patients, the ICER of the anti-VEGF injection (compared with PRP) might be overestimated.

The effectiveness of anti-VEGF therapy may be underestimated in our study because the EQ-5D has no vision-related questions. The HRQoL of the blindness state had a great influence on our outcomes. We performed additional analysis that involved the Health Utility Index 3 tool, including a visual acuity question from previous literature [28] regarding HRQoL and found that the ICER of the anti-VEGF injection-only strategy (compared with the PRP-only method) fell from $33,405 per QALY to $9,209 per QALY.

Our study has several limitations. The Markov model assumes that DR in both eyes will progress with the same severity and at the same response rate to the treatment. Since diabetes is a systemic illness, it is reasonable to conclude that diabetes affects the retina in both eyes, but the severity of DR can be different between the eyes in a clinical setting. Another limitation is that some parameters from the anonymized hospital data showed differences from the values reported in prior research. This may be because the data were sourced from only a few medical institutions (not all patients) in South Korea, or to the low validity of hospital-based data by the loss of follow-up and transfer to other hospitals. To compensate for this limitation of hospital-based data, we performed literature review on some parameters.

In sum, although anti-VEGF injection is frequently used as an effective alternative to PRP treatment, the anti-VEGF injection has several limitations, such as a high cost and repeated injections. In our study, the anti-VEGF injection for PDR was cost-effective from the payer and societal perspectives. Our results on the cost-effectiveness of the anti-VEGF injection for PDR, alone or in combination with PRP treatment, can be used as important evidence when making medical service decisions.

anti-VEGF

anti-vascular endothelial growth factor

CDW

Clinical Data Warehouse

CEAC

cost-effectiveness acceptability curve

DME

diabetic macular edema

diabetic retinopathy

EQ-5D-3L

EuroQol five-dimensions with a 3-level questionnaire

HRQoL

health-related quality of life

ICER

incremental cost-effectiveness ratio

NEI-VFQ-25

National Eye Institute Visual Function Questionnaire with 25 items

NHIS

National Health Insurance Service

NPDR

non-proliferative DR

PDR

proliferative DR

PRP

panretinal photocoagulation

pVFD

peripheral visual field defect

QALY

quality-adjusted life year

risk ratio

SVL

severe visual loss

USD

US dollar

Ethics approval and consent to participate

Written informed consent was obtained from study participant. The study adhered to the Declaration of Helsinki and was approved by the Institutional Review Board of National Evidence-based Healthcare Collaborating Agency (NECAIRB20-018).

Consent for publication

Not applicable.

Availability of data and materials

The datasets used during the current study are available from the corresponding author on reasonable request.

We would like to thank professors Jin-Woo Kwon, Minjoo Kang, andSeong-hee Hwang for their contributions to this paper.

Funding

This research was supported by the National Evidence-based Healthcare Collaborating Agency (NECA), which is funded by South Korea’s Ministry of Health and Welfare (Grant #NA20-011, NAM21-004). The funding sources had no role in the identification, design, conduct, and reporting of the analysis.

Competing interests

The authors declare no competing interests.

Authors contributions

All authors have made substantial contributions to this study. HJL was involved in conception, analysis and interpretation of data, drafting the manuscript. DJ was involved in conception, acquisition of data, and revising the manuscript critically. SC, JY and HMK were involved in analysis of data. JP was involved in data extraction. All authors have read and approved the final manuscript.

Authors’ information

Division of Healthcare Technology Assessment Research, National Evidence-based Healthcare Collaborating Agency, Seoul, South Korea

Hyeon-Jeong Lee &Jungeun Park

Patient-Centered Clinical Research Coordinating Center, National Evidence-based Healthcare Collaborating Agency, Seoul, South Korea

Songhee Cho

Department of Rehabilitation, College of Acupuncture and Moxibustion and Massage Health Preservation and Rehabilitation, Nanjing University of Chinese Medicine, Jiangsu, China

Yan Jin

Artificial intelligence, Kai Health, Seoul, South Korea

Hyung Min Kim

Department of Ophthalmology and Visual Science, St. Vincent’s Hospital, The College of Medicine, Catholic University of Korea, Suwon, South Korea

Donghyun Jee

Corresponding author

Donghyun Jee

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No competing interests reported.

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Supplementary information Supplementary Table 1 An outline of the economic evaluation Supplementary Table 2 Model parameters: baseline values, ranges, and distributions for sensitivity analysis

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published 11 Dec, 2023

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Cost-effectiveness of the anti-vascular endothelial growth factor intravitreal injection and panretinal photocoagulation for patients with proliferative diabetic retinopathy in South Korea

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Abstract

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Background

Method

Target population

Treatment strategies

Model structure

Model assumptions

Cohort simulation

Model parameters

Treatment-related probability

Cost

Utility

Analysis

Results

Base case results

Sensitivity analysis

Discussion And Conclusion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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