Abstract
Background/Objectives
Alzheimer's disease (AD) exerts a considerable economic burden on South Korea's aging population. Lecanemab, an amyloid-targeting therapy, has demonstrated efficacy in mitigating cognitive decline in early-stage AD but remains non-reimbursed in South Korea due to concerns over its economic feasibility. This study aimed to examine the cost-effectiveness of lecanemab using nationwide claims data for cost estimation within the South Korean healthcare system. Considering the substantial societal burden of AD, we also evaluated the cost-effectiveness of lecanemab from a limited societal perspective.
Methods
A Markov state transition cohort model was developed to compare costs and outcomes of lecanemab combined with standard of care (SoC) versus SoC alone. The model simulated five stages of AD progression: mild cognitive impairment, mild AD, moderate AD, severe AD, and death. Transition probabilities between health states were derived from data provided by the National Alzheimer’s Coordinating Center. Formal medical costs and long-term care costs were obtained from the national claims database, while drug cost and other medical expenses were derived from previous studies. Additional cost components such as opportunity cost of caregiver time, out-of-pocket expenses, and time and travel costs for hospital visits were included in the limited societal perspective. Korean-specific utilities for patients and caregivers differentiated by states of AD progression and care settings were obtained from the published literature. Effectiveness was measured in quality-adjusted life years (QALYs) over a lifetime horizon. Scenario analyses were conducted by varying compositions of the cohort, age of onset, and drug pricing.
Results
The incremental cost-effectiveness ratio (ICER) of lecanemab combined with SoC was 198,171,820 Korean Won (KRW)/QALY from the healthcare payer perspective and 181,185,820 KRW/QALY from the limited societal perspective, which significantly exceeded South Korea’s willingness-to-pay (WTP) threshold of 30 million KRW/QALY. Sensitivity analyses revealed that the ICER was highly influenced by variations in treatment effect and discount rates. The result of scenario analyses suggested that targeting lecanemab to patients with mild AD or implementing price reductions could substantially improve its cost-effectiveness.
Conclusions
Lecanemab's high cost poses a challenge to its inclusion in the National Health Insurance formulary under South Korea’s current WTP thresholds. Strategic price adjustments and patient targeting are essential to enhance its economic viability. These findings provide valuable insights for policymakers and stakeholders in balancing treatment outcomes and resource allocation for AD management.
Supplementary Information
The online version contains supplementary material available at 10.1007/s41669-025-00593-z.
Key Points for Decision Makers
| Lecanemab’s incremental cost-effectiveness ratio (ICER) exceeds South Korea’s willingness-to-pay (WTP) threshold of 30 million Korean Won (KRW)/quality-adjusted life year (QALY) by more than 150 million KRW/QALY in the treatment of Alzheimer’s disease (AD). Even with the limited societal perspective accounting for caregiver burden, the ICER remains nearly six times higher than the threshold, posing challenges for National Health Insurance (NHI) reimbursement. |
| Limiting lecanemab’s use to patients with mild AD improved the ICER by up to 40% through reduced treatment duration and cost savings, while maintaining stable QALY outcomes. Targeting younger patients further enhanced cost-effectiveness by up to 10%. |
| Drug pricing is the key determinant of ICER, with a halving of lecanemab’s price improving cost-effectiveness by over 52%. Price reductions of 55–70%, consistent with other new drugs in Korea, may be required to achieve NHI coverage. |
| Findings highlight the importance of strategic decision-making in NHIS coverage policies for lecanemab, balancing high treatment costs with the need for effective AD management. |
Introduction
Alzheimer's disease (AD) is a major cause of dementia, accounting for over 70% of cases in South Korea [1]. The country’s rapidly aging population poses a growing challenge [2–4]. The number of dementia patients increased from 188,000 in 2009 to 935,000 in 2022, and the prevalence of mild cognitive impairment (MCI) also increased by 19-fold from 15,000 to 300,000 during the same period [1]. The total cost of dementia care in South Korea was estimated at 20.8 trillion Korean Won (KRW) in 2022, with projections suggesting a surge to as much as 163 trillion KRW by 2060. The financial burden tends to increase as dementia progresses. In 2022, the total healthcare expenditure per patient with severe dementia was approximately 35 million KRW annually, which is more than double the expenditure of a patient with MCI [3]. In response to the escalating prevalence and cost of dementia, the Korean government has launched several strategic initiatives, including the ‘National Responsibility Policy for Dementia Care’ and the ‘Comprehensive Dementia Management Plan,’ to actively promote early detection and intervention for dementia patients.
The recently Food and Drug Administration (FDA)-approved treatment lecanemab demonstrated the potential to modify disease progression in patients with MCI and mild AD by targeting amyloid plaques [5, 6]. However, the high cost of the drug is often a major obstacle to reimbursement through the health insurance system [7]. The Institute for Clinical and Economic Review has reported that, at an annualized United States (US) price of 26,500 US dollars (USD), lecanemab does not achieve cost-effectiveness, necessitating a 66% price reduction to align with a willingness-to-pay (WTP) threshold of 100,000 USD in the US [8]. Similarly, research in the US and Japan has consistently found that lecanemab’s price surpasses the value-based price (VBP) determined at their respective WTP thresholds [9, 10]. Yet, previous studies indicate that early intervention, especially at the MCI stage, enhances the cost-effectiveness of lecanemab [9]. The study from Japan also highlighted that longer life expectancy can extend the benefits of treatment, increasing its overall value [10].
South Korea operates a universal healthcare system through National Health Insurance (NHI), which provides the coverage for approximately 97% of the total population [11]. Despite the country’s rapidly aging population and the anticipated rise in the societal and economic burden of AD, lecanemab remains an out-of-pocket, non-reimbursed treatment option. However, South Korea has been successful in screening for dementia in its early stages through the national dementia management plan [12]. Additionally, the country’s affordable healthcare system, combined with better overall health and longer life expectancy among its aging population, can be salient factors in making lecanemab more cost-effective in South Korea compared to the US or Japan [2, 13].
The specific aims of this study were to estimate the treatment costs of AD by health state within the context of South Korea’s healthcare system and to determine the cost-effectiveness of lecanemab in managing AD from both healthcare payer and limited societal perspectives. For the analysis, we used South Korea’s National Health Insurance Service (NHIS) claims data for the cost estimation. Notably, South Korea’s NHI provides coverage for long-term care, allowing for the inclusion of caregiver costs as part of the healthcare payer’s expenses. Estimating broader costs, such as productivity losses of AD patients or other indirect costs, involves considerable measurement uncertainty. By focusing primarily on direct healthcare costs for patients while including the time cost of informal caregiving, a limited societal perspective offers a more objective and manageable approach to cost estimation. This approach also acknowledges a broader disease burden that may not be fully captured by a healthcare payer perspective alone but is of interest to the national healthcare payer. We also aimed to identify the strategic decision variables pivotal to the NHI coverage decision via scenario analysis. The findings from this study would offer valuable insights into the economic viability of lecanemab, guiding NHI coverage decisions and potentially affecting whether to include it in the guidelines for AD treatment. They would also inform stakeholders of ways to balance treatment outcomes and resource allocation.
Materials and Methods
Study Design
A cost-effectiveness analysis was conducted to evaluate the economic impact of lecanemab combined with standard of care (SoC) compared to SoC alone for patients with early-stage AD. The SoC encompassed both non-pharmacological measures and symptom-targeted treatments, including donepezil, rivastigmine, galantamine, and memantine, as outlined in the Korean clinical practice guideline for dementia [14]. The study employed a Markov state transition cohort model to simulate AD progression and associated costs and outcomes over a lifetime horizon. The analysis was conducted from two perspectives – the healthcare payer perspective and the limited societal perspective—to comprehensively assess the economic impact of intervention [8]. One-way sensitivity analyses were performed to examine the robustness of the results. Scenario analyses were conducted by varying assumptions related to treatment initiation stage, patient demographics, and drug pricing. Our findings were reported following the guidelines of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), which are provided in Supplementary Table S1 (see the electronic supplementary material) [15].
Study Cohort
Our patient cohort consisted of 1000 individuals who were diagnosed with MCI or mild AD, which mirrored the characteristics of the patients who participated in CLARITY AD, a multicenter, global, randomized, placebo-controlled trial (ClinicalTrials.gov identifier, NCT03887455) [6]. The cohort, aged 71 and older, comprised 48% men and 52% women. We also assumed that 70% of the patients had MCI and 30% had mild AD, reflecting the distribution of Korean patients with AD (Table 1) [16].
Table 1.
Base-case patient characteristics and model inputs
| Parameters | Value | Uncertainty range | Distributiona | References |
|---|---|---|---|---|
| Initial dementia stage, proportion of cohort | ||||
| MCI | 70% | – | – | [16] |
| Mild AD | 30% | – | – | [16] |
| Setting of care | ||||
| Community | 95% | – | – | [1] |
| Long-term care | 5% | – | – | [1] |
| Proportion institutionalized | ||||
| Mild AD | 5.5% | 4–7% | β | [10] |
| Moderate AD | 13.2% | 11–16% | β | [10] |
| Severe AD | 29.6% | 24–36% | β | [10] |
| Mortality with AD, HR (vs. general population) | ||||
| MCI due to AD | 1.14 | 0.91–1.37 | Log-normal | [10] |
| Mild AD | 1.55 | 1.24–1.86 | Log-normal | [10] |
| Moderate AD | 2.80 | 2.24–3.36 | Log-normal | [10] |
| Severe AD | 5.48 | 4.38–6.58 | Log-normal | [10] |
| Discontinuation rate | ||||
| Annual rate | 13.0% | 10–20% | β | [6] |
| Patient utilities (community care) | ||||
| MCI due to AD | 0.75 | 0.69–0.82 | β | [17] |
| Mild AD | 0.43 | 0.30–0.57 | β | [17] |
| Moderate AD | 0.25 | 0.15–0.36 | β | [17] |
| Severe AD | 0.10 | − 0.08 to 0.28 | β | [17] |
| Patient utilities (institutional care) | ||||
| MCI due to AD | 0.28 | 0.24–0.32 | β | |
| Mild AD | 0.18 | 0.15–0.21 | β | [18] |
| Moderate AD | 0.15 | 0.13–0.17 | β | [18] |
| Severe AD | 0.06 | 0.05–0.07 | β | [18] |
| Adverse event disutilities (ARIA) | ||||
| Symptomatic ARIA | 0.1 | – | – | [19] |
| Caregiver disutilities | ||||
| MCI due to AD | 0.08 | – | – | [18] |
| Mild AD | 0.16 | – | – | [18] |
| Moderate AD | 0.23 | – | – | [18] |
| Severe AD | 0.24 | – | – | [18] |
| General | ||||
| Discount rate | 4.5% | 0–5% | – | [20] |
AD Alzheimer’s disease, ARIA amyloid-related imaging abnormalities, HR hazard ratio, MCI mild cognitive impairment
aDistributions were selected based on parameter characteristics: beta for proportions and utility values (bounded between 0 and 1); log-normal for HRs (positive and right-skewed)
Model Structure
A Markov state transition model was built for individuals diagnosed with MCI or mild AD over the patient's lifetime horizon on an annual cycle (Fig. 1). We adapted five stages of AD progression: MCI due to AD, mild AD, moderate AD, severe AD, and death, based on the previously published studies [8, 21, 22]. Each state was defined according to its Clinical Dementia Rating Sum of Boxes (CDR-SB) scoring ranges consistent with lecanemab efficacy analyses from the CLARITY AD trial: MCI (0.5–4.0), mild AD (4.5–9.0), moderate AD (9.5–15.5), and severe AD (16–18) [23]. To reflect the complexity of disease progression, our model allows transitions not only to the subsequent severity level but also to non-sequential or even less severe states under certain circumstances. Furthermore, each health state is subdivided into community and institutionalized settings. While progression from the community to an institutionalized setting is permitted, once a patient is institutionalized, transitions back to the community are not allowed. Finally, transitions to the death state are possible from any health state, in line with the natural course of AD and its associated comorbidities. We assumed that a significant portion of the patients with mild AD (95%) were initially cared for in a community care setting, while all the patients with MCI were cared for in a community setting [1]. These patients could also transition from community care to long-term care, where they remained until death. For each cycle, a half-cycle correction was used based on the Korean economic evaluation guideline [20].
Fig. 1.
Markov transition model structure. Gray arrows indicate transitions between health states. AD Alzheimer’s disease, MCI mild cognitive impairment
Transition Probabilities
Transition probabilities between health states were derived from data provided by the National Alzheimer’s Coordinating Center (Table 2) [8]. The annual transition probabilities between health states were defined as the probability of moving from the current health state (row) to the subsequent health state (column) in each model cycle, and were conditional on patients surviving through each model cycle. The treatment effect of lecanemab, expressed as a hazard ratio (HR) for MCI or mild AD progressing to moderate AD, is set at 0.69 based on the CLARITY AD trial. The HR was reported in a prespecified, multiplicity-unadjusted time-to-event analysis evaluating progression to the next stage of AD. This indicates that lecanemab results in about a 30% reduction in the risk of progression from MCI or mild AD to moderate AD compared to SoC [8]. Regarding lecanemab’s potential to slow the progression from moderate AD to severe AD, we assumed, consistent with the Institute for Clinical and Economic Review report, that lecanemab would no longer be effective at this stage. State-specific transitions from community-based care to institutional care were obtained from a Japanese study [10]. Transitions from each health state to death were determined by state-specific HRs of mortality, which were multiplied by their respective age- and sex-adjusted mortality rates. The mortality rates were derived from life tables of the Korean population [24].
Table 2.
Transition probabilities between health states
| MCI due to AD | Mild AD | Moderate AD | Severe AD | |
|---|---|---|---|---|
| MCI due to AD | 0.77 | 0.23 | – | – |
| Mild AD | 0.03 | 0.58 | 0.35 | 0.04 |
| Moderate AD | – | 0.03 | 0.55 | 0.42 |
| Severe AD | – | – | 0.02 | 0.98 |
AD Alzheimer's disease, MCI mild cognitive impairment
According to the CLARITY AD trial, patients receiving lecanemab experienced a treatment discontinuation rate of 18.8%, compared to 15.6% in patients receiving placebo during the 18-month duration [6]. Moreover, discontinuation due to side effects was higher in the lecanemab group than in the placebo group (6.9% vs. 2.9%). The 18-month discontinuation rates were converted to annual ones, e.g., a 13% discontinuation for lecanemab. Lastly, we assumed that progression to moderate AD necessitates treatment discontinuation.
Adverse Events
In the CLARITY AD trial, lecanemab and placebo had no significant difference in resulting in death or serious adverse events (AEs) [6]. Common AEs resulting from lecanemab were infusion reactions, amyloid-related imaging abnormalities (ARIA) with cerebral microhemorrhages, cerebral macrohemorrhages, or superficial siderosis, headaches, and falls. Notably, most ARIA events were asymptomatic, emerged mainly in the first 3 months, and resolved within 4 months. Accordingly, we assumed all ARIA events occurred in the first cycle, with a 21.5% chance of any ARIA and a 3.5% chance of symptomatic ARIA.
Utility
Patient utilities, differentiated by states of AD progression and care settings (community versus institutional), were obtained from the published literature (Table 1). Utilities of patients in different care settings were derived from a cross-sectional study that collected EQ-5D-5L data from elderly patients receiving community or institutional care in South Korea [17]. Under the healthcare payer perspective, only quality-adjusted life years (QALYs) gained by the patient were considered. In contrast, the limited societal perspective accounted for QALYs gained by both the patient and informal caregivers, capturing the broader societal impact of the intervention. The limited societal perspective included disutilities of informal caregivers, which were assumed to be the same for community and institutional setting. Even after institutionalization of the patient, caregivers often continue to experience psychological distress—including guilt, anxiety, and grief— related to placing a loved one in care, concerns about disease progression, and the ongoing burden of care coordination. In countries like South Korea and Japan, cultural expectations frequently require family members to remain actively involved in caregiving tasks, such as providing meals, clothing, and personal care, as well as participating in routine care decisions. These sustained responsibilities suggest that caregiver disutility may persist even in institutional care settings [25, 26]. Assuming each patient has one caregiver, the QALYs lost due to the caregiver’s disutility were subtracted from the patient’s QALYs gained to estimate the net QALY gain [18]. All patients who experienced an ARIA event were assigned a disutility value of 0.09 for 12 weeks, which is the same disutility value associated with a mild migraine (the most common symptom of ARIA) [19].
Costs
For the healthcare payer perspective, we included drug cost, long-term care cost (formal caregiver costs), and other direct medical costs (Table 3). For patients receiving lecanemab, additional costs for drug administration and magnetic resonance imaging (MRI) monitoring were also included. The limited societal perspective included three additional cost components beyond those considered in the healthcare payer’s perspective: (1) informal care costs, reflecting the opportunity cost of caregiver time; (2) informal medical costs, such as out-of-pocket expenses for medical supplies and over-the-counter medications; and (3) direct non-medical costs, including travel time and transportation expenses for hospital visits. For patients in institutional care settings, informal care and travel-related costs were excluded under the assumption that such services are encompassed within the long-term care costs.
Table 3.
Annual costs by AD stage and evaluation perspective
| Parameters (KRW) | MCI | Mild AD | Moderate AD | Severe AD | References | |
|---|---|---|---|---|---|---|
| Annual community care costs, mean (SE) | ||||||
| Formal medical costs | 578,155 (68,632) | 1,689,345 (200,541) | 4,376,298 (229,821) | 6,707,647 (743,742) | NHIS claims database | |
| Long-term care costs | – | 6,535,691 (565,835) | 7,527,731 (251,551) | 5,295,850 (642,337) | NHIS claims database | |
| Informal medical costs | 109,532 (55,820) | 187,469 (68,580) | 236,970 (82,591) | 491,844 (295,005) | [17] | |
| Hospital visit costs | 43,181 (9742) | 74,777 (22,573) | 152,714 (33,417) | 61,085 (23,499) | [17] | |
| Informal care costs | 1,535,565 (569,255) | 10,282,391 (2,142,741) | 6,371,860 (1,502,033) | 13,395,650 (4,814,402) | [17] | |
| Total costs for healthcare payer perspective | 578,155 (68,632) | 8,225,036 (326,912) | 11,904,029 (235,768) | 12,003,497 (705,579) | ||
| Total costs for limited societal perspective | 2,299,435 (252,296) | 18,866,104 (601,127) | 18,915,382 (316,286) | 26,334,964 (1,185,856) | ||
| Annual institutional care costs, mean (SE) | ||||||
| Formal medical costs | 578,155 (68,632) | 1,689,345 (200,541) | 4,376,298 (229,821) | 6,707,647 (743,742) | NHIS claims database | |
| Long-term care costs | – | 7,147,071 (2,582,286) | 15,279,344 (428,409) | 16,232,487 (877,874) | NHIS claims database | |
| Informal medical costs | 109,532 (55,820) | 187,469 (68,580) | 236,970 (82,590) | 491,844 (295,005) | [17] | |
| Total costs for healthcare payer perspective | 578,155 (68,632) | 8,836,416 (442,732) | 19,655,64 (272,734) | 22,940,134 (792,525) | ||
| Total costs for limited societal perspective | 720,689 (154,310) | 9,120,316 (422,982) | 20,142,421 (269,495) | 23,814,866 (774,346) | ||
| Parameters | Costs | References | ||||
| Annual drug cost | ||||||
| Lecanemab | 26,870,785 | [11, 20] | ||||
| Administration costs | 81,848 | [29] | ||||
| Screening costs | ||||||
| MRI unit costa | 300,000 | [32, 33] | ||||
AD Alzheimer’s disease, KRW Korean Won, NHIS National Health Insurance Service, MCI mild cognitive impairment, MRI magnetic resonance imaging, SE standard error
aAssumed based on average cost in tertiary general hospitals
Annual treatment costs for lecanemab were estimated as 26,870,785 KRW (2022 constant KRW) based on US wholesale acquisition cost (WAC) per vial [27], considering the recommended dosage of 10 mg/kg and the average body weight of 60 kg of the Korean elderly population [20, 28]. The treatment costs included fees for drug administration and prognosis monitoring, which involved four MRI scans during the initial year [29]. In addition, patients experiencing an ARIA event were assumed to undergo a brain MRI every 4 weeks for 12 weeks, corresponding to the average duration of an ARIA event.
To estimate the direct medical costs, the study utilized the Korean NHIS claims data, which electronically document all payments made for covered healthcare services [30]. To estimate the medical costs of three AD states, each state was defined operationally based on time since diagnosis, drug usage, and long-term care levels. Direct medical costs associated with AD-induced MCI were estimated using severity-based weights from the National Dementia Annual Report, since a specific disease code was unavailable in the NHIS database [1]. Caregiving costs in an institutional setting were also identified and obtained from NHIS claims data.
We assumed that the healthcare costs of each state do not vary between community and institutional settings. Costs incurred informally in a community setting were estimated based on a recent survey in Korea that evaluated caregiver time spent caring for an AD patient [17]. Also, the costs used for the limited societal perspective were estimated from surveys reported in previous literature [17]. All costs from previous years were adjusted to 2022 KRW using the annual healthcare consumer price index published by the Korean Statistical Information Service (KOSIS). An exchange rate of 1 USD = 1320 KRW was used for reference [31].
Analysis
We calculated the incremental cost-effectiveness ratios (ICERs) as the additional cost per QALY gained. An annual discount rate of 4.5% was applied for both costs and outcomes, following the Korean economic evaluation guideline [20]. To identify the main factors impacting cost-effectiveness, we implemented one-way sensitivity analyses. This involved changing input parameters within their uncertainty ranges to observe how these changes affected the ICERs when just one parameter was altered. We also conducted probabilistic sensitivity analyses (PSA) to account for joint uncertainty across all input parameters. The model was run for 1000 iterations, with input values randomly drawn from their respective probability distributions, in each iteration. As shown in Table 1, probability distributions were specified for all input variables with uncertainty, while constants were used for those with no variability; for cost variables (Table 3), a gamma distribution was applied to reflect their right-skewed nature. This approach enabled us to evaluate and assess the overall uncertainty in the model outcomes attributable to input parameter variability.
In addition, we conducted scenario analyses to examine the effects of different population subsets, by varying underlying assumptions on our model. Since the cost of lecanemab is not yet established in Korea, we also performed an evaluation of various price reductions. This was done to ascertain the impact that potential price adjustments might have on the ICERs relative to the base-case assumption, providing insights into how different pricing strategies could influence cost-effectiveness outcomes. We used Microsoft Office Excel (by Microsoft Corporation, Redmond, WA, USA) and SAS 9.4 for analyzing the study.
Results
Cost-Effectiveness of Lecanemab
Medical costs increased with the severity of AD, with severe AD costing 6,707,647 KRW, nearly four times as much as the 1,689,345 KRW for mild AD (Table 3). Long-term care costs also rose, with more patients using institutional care rather than community care as AD progresses. Notably, institutional care costs at each stage were more than three times higher than the medical costs, comprising a significant portion of the total care expenses for AD patients. When societal costs, including informal care, were considered, the total expenses were higher for both community care and institutional care when compared to the healthcare payer perspective.
The ICER for lecanemab combined with SoC was 198,171,820 KRW/QALY (1 USD = 1320 KRW, 151,130 USD/QALY) over a lifetime horizon, compared to SoC alone, from the perspective of the Korean healthcare system (Table 4). Specifically, lecanemab treatment costed 83 million KRW more than SoC alone while providing a 0.42 QALY gain. From the limited societal perspective, which accounts for caregiver burden, the ICER improved to 181,185,820 KRW/QALY (137,262 USD/QALY), reflecting an approximate 8.6% reduction compared to the healthcare payer perspective.
Table 4.
Economic evaluation of LEC plus SoC versus SoC by each perspective
| Modeled outcomes | Healthcare payer | Limited societal | |||
|---|---|---|---|---|---|
| SoC | LEC+SoC | SoC | LEC+SoC | ||
| Time on treatment (year) | – | 3.64 | – | 3.64 | |
| Total LYs | 9.68 | 10.09 | 9.68 | 10.09 | |
| Total QALY | 3.00 | 3.42 | 1.70 | 2.16 | |
| Total Costs (KRW) | 76,758,127 | 159,843,201 | 118,928,782 | 201,948,809 | |
| Incremental QALY | 0.42 | 0.46 | |||
| Incremental costs (KRW) | 83,085,074 | 83,020,027 | |||
| ICER (KRW/QALY) | 198,171,820 | 181,185,820 | |||
ICER incremental cost-effectiveness ratio, KRW Korean Won, LEC lecanemab, LY life year, QALY quality-adjusted life year, SoC standard of care
Sensitivity Analyses
Incorporating uncertainties in key parameter estimates – such as treatment effect, discount rate, utility values, and cost inputs – resulted in variations in the ICER (Fig. 2). The widest variation was observed with the treatment effect. At the 95% confidence interval (CI) for the treatment effect (HR 0.57–0.83), the ICER varied significantly, ranging from a decrease of 28.3% to an increase of 73.9%, compared to the ICER evaluated at its mean value of 0.69. The discount rate was the second most influential factor affecting the ICER. When varying the discount rate from 0 to 5% per year, the ICER increased by 1.6% at a 0% discount and decreased by 14.8% at a 5% discount. The utility of the MCI state also caused a substantial variation with the ICER ranging from 8.8 to − 8.1% for its lower and upper CI, respectively. Other variables did not markedly affect the ICER results, with variations of less than 5% observed in the sensitivity analyses.
Fig. 2.
Tornado diagram of one-way sensitivity analyses results. CI confidence interval, HR hazard ratio, ICER incremental cost-effectiveness ratio, MCI mild cognitive impairment
PSA showed that at a WTP threshold of 100 million KRW, the acceptability of lecanemab was close to zero. The WTP threshold would need to rise to approximately 200 million KRW for lecanemab to become a more acceptable option than SoC (Supplementary Fig. S1; see the electronic supplementary material).
Scenario analyses
Scenario analyses identified strategic decisions necessary to obtain NHI coverage for lecanemab. If lecanemab was initiated exclusively for patients with MCI due to AD, the ICER would increase by 19.4% to 236,664,195 KRW/QALY in the healthcare payer perspective and by 21.8% to 220,659,484 KRW/QALY in the limited societal perspective (Table 5). However, the ICER improved by as much as 40% if initiated for patients with mild AD only; specifically, 40.1% for the healthcare payer perspective and 41.3% for the limited societal perspective. Initiating lecanemab treatment for younger patients with a mean age of 65 years improved the ICER by 8.0% for the healthcare payer perspective and by 10.0% for the limited societal perspective.
Table 5.
Scenario analysis results
| Scenarios | Healthcare payer perspective | Limited societal perspective | ||||||
|---|---|---|---|---|---|---|---|---|
| Δ QALYs | Δ costs | ICER | % change | Δ QALYs | Δ costs | ICER | % change | |
| Base case | 0.42 | 83,085,074 | 198,171,820 | – | 0.46 | 83,020,027 | 181,185,820 | – |
| Initial indication | ||||||||
| 100% MCI due to AD | 0.40 | 95,492,672 | 236,664,195 | 19.4% | 0.43 | 94,572,026 | 220,659,484 | 21.8% |
| 100% mild AD | 0.46 | 54,134,012 | 118,704,786 | − 40.1% | 0.53 | 56,065,360 | 106,323,937 | − 41.3% |
| Initial age (years) | ||||||||
| Mean age 65 | 0.46 | 84,088,355 | 182,253,402 | − 8.0% | 0.52 | 84,331,885 | 163,090,574 | − 10.0% |
| Mean age 70 | 0.43 | 83,400,787 | 194,816,726 | − 1.7% | 0.47 | 83,387,209 | 177,478,978 | − 2.0% |
| Mean age 75 | 0.38 | 80,717,871 | 215,236,107 | 8.6% | 0.40 | 80,479,280 | 199,625,780 | 10.2% |
| Drug cost reduction | ||||||||
| 10% reduction | 0.42 | 74,374,021 | 177,394,499 | − 10.5% | 0.46 | 74,308,973 | 162,174,512 | − 10.5% |
| 30% reduction | 0.42 | 56,951,915 | 135,839,857 | − 31.5% | 0.46 | 56,886,867 | 124,151,896 | − 31.5% |
| 50% reduction | 0.42 | 39,529,809 | 94,285,215 | − 52.4% | 0.46 | 39,464,761 | 86,129,280 | − 52.5% |
AD Alzheimer’s disease, ICER incremental cost-effectiveness ratio, MCI mild cognitive impairment, QALY quality-adjusted life year
Notably, changes in the treatment cost of lecanemab were almost directly proportional to changes in ICER, highlighting the significant impact of drug cost on cost-effectiveness. When the cost of lecanemab was halved, the ICER improved by more than 52%; specifically, 52.4% in the healthcare payer perspective and 52.5% in the limited societal perspective. This relationship was downward sloping, indicating improvements of more than 180,000,000 KRW/QALY resulting from 90% reductions in lecanemab’s cost (Supplementary Figure S2; see the electronic supplementary material).
Discussion
This study evaluated the ICER of adding lecanemab to SoC for early-stage AD in South Korea, compared to SoC alone. The findings showed that the ICER significantly exceeded the commonly referenced WTP threshold in South Korea, 30 million KRW per QALY, by more than 150 million KRW [34]. The primary factor contributing to this elevated ICER was the high cost of lecanemab, which was set at 80% of the US WAC, reflecting the reduced dosage required for Korean patients, who typically have lower body weights than US patients [11, 20, 28]. Despite this cost adjustment, as well as South Korea's longer life expectancy and lower dementia mortality rates, which reduced the ICER to two-thirds of that in the US (198 million KRW/QALY vs. 300 million KRW/QALY), the price of lecanemab remained a considerable barrier [8]. The ICER was still nearly six times higher than the WTP threshold, posing a significant challenge to obtaining NHI coverage [34].
Currently, no accurate pricing information on lecanemab is available in Korea, as it remains unreimbursed. It remains uncertain whether the drug's sponsor will consider reducing the price by as much as 80% to secure NHI coverage. Although such a significant reduction may seem improbable given lecanemab's status as a breakthrough disease-modifying therapy, it is not without precedent. Price reductions for new drugs recently introduced in Korea have ranged from 55 to 70% of their US prices, indicating that a substantial discount is indeed a possibility given an increasing prevalence of dementia [35].
Another feasible strategy to enhance lecanemab’s cost-effectiveness involves targeting its use specifically to patients with mild AD rather than including those with MCI due to AD. Our scenario analysis revealed that focusing on patients with mild AD improved the ICER by as much as 40% compared to a broader patient group. This improvement stems from reducing the duration of treatment from 3.64 years to 2.23 years, by limiting lecanemab's use to those with mild dementia only. A similar trend was observed in a study in Japan [10]. The adjustment led to savings in lifetime treatment costs of up to 30 million KRW, while the loss in QALY remained relatively stable. Based on these findings, it is plausible to prioritize lecanemab for patients who are most likely to derive the greatest value from the treatment.
For Korean markets, the potential for lecanemab to improve cost effectiveness with its targeted use may open up a venue for a managed entry agreement between the drug sponsor and the NHIS. Such an agreement would likely include measures to balance cost-effectiveness with early patient access, reflecting both the therapeutic promise of lecanemab and the economic realities of the NHIS [36]. Specifically, it seems plausible to implement an outcome-based risk-sharing agreement (RSA) that links payment to treatment success [37]. Our scenario analysis showed that the ICER varied widely according to the levels of lecanemab’s treatment efficacy. The drug sponsor and the NHIS then can agree to an RSA that pays only for those patients who were successfully treated.
The limitations of our study include reliance on international data sources due to the lack of domestic data, such as mortality rates from AD, the proportion of institutional care, and health state transition probabilities. To minimize the impact of using non-domestic data, we sourced the HR for mortality and the transition probabilities to institutional care from Japanese studies, given the demographics and healthcare system similarities between Japan and Korea [38]. However, health state transition probabilities were derived from a well-known US cohort study [8], which may not fully capture Korea-specific care patterns, healthcare utilization, or patient behavior – all of which may influence treatment outcomes. Although prior research suggests that disease progression patterns do not differ substantially between the US and Asia [39], the use of international data still presents a limitation in generalizing our findings to the Korean context, and thus warrants cautious interpretation. Furthermore, our analysis assumed that the effects of lecanemab would persist beyond the 18-month clinical trial period, based on a prior model-based simulation study and open-label extension of the CLARITY AD trial, without accounting for potential impacts on patient mortality [40, 41]. Given that treatment effect is a key determinant of cost-effectiveness, any decline in lecanemab’s effectiveness over time would lead to a corresponding reduction in its cost-effectiveness.
The treatment effect of HR 0.69 used in this study was directly reported in the CLARITY AD trial, reflecting a reduced risk of progression to the next stage of AD. However, this effect may not fully generalize to real-world settings, highlighting the importance of conducting sensitivity analyses. As the CLARITY AD trial did not fully report the CI for the treatment effect, our analysis referenced the CI provided by the Institute for Clinical and Economic Review. Given that the institute also noted the substantial uncertainty surrounding this estimate, further long-term observational studies in the real-world settings – particularly within Asian populations – are essential to more accurately assess the effectiveness of lecanemab.
Additionally, using EQ-5D-5L utilities to value health outcomes in dementia patients presents several limitations. First, the EQ-5D-5L may not fully capture the cognitive and functional declines specific to dementia [42]. Dementia primarily affects cognitive domains such as memory, attention, and problem-solving, which are not explicitly addressed in the EQ-5D-5L. Furthermore, the scores of dementia patients could introduce bias depending on who reports them [43]. Self-reporting can be problematic because many dementia patients are unable to accurately report their health status due to cognitive impairments. Proxy reporting is also challenging, as proxies may under- or overestimate the patient’s quality of life based on their perceptions and emotional involvement.
Lastly, the limited societal perspective adopted in this study focused mainly on caregiver time costs, potentially underestimating the broader social burden of AD [44]. Despite limited data on productivity loss among Korea’s elderly, evidence from the US and Japan suggests that including these losses could significantly lower the ICER, enhancing the cost-effectiveness of treatments [8–10]. Further research is essential to fully capture the societal impacts of AD treatments in South Korea.
Conclusions
In conclusion, this study highlights significant considerations for the cost-effectiveness and strategic deployment of lecanemab in treating early-stage AD within South Korea's healthcare system. Although the ICER for lecanemab substantially exceeds South Korea's WTP threshold, primarily due to its high cost, there are viable strategies to enhance its economic viability. Stakeholders should consider both price adjustments and patient targeting as critical factors in the decision-making process for the inclusion of lecanemab in treatment protocols. Implementing these strategies could facilitate the adoption of lecanemab into the NHI formulary, thus enabling broader access to this potentially transformative therapy while ensuring alignment with economic constraints.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgments
We thank the Research Institute of Pharmaceutical Science and College of Pharmacy, Seoul National University, and 2023 Health Fellowship Foundation for supporting this study.
Declarations
Author Contributions
Seungyeon Shin and Maryanne Kim contributed equally to this work. Conceptualization and design: Shin, Kim, and Hong. Data acquisition, analysis, and interpretation: Shin and Hong. Statistical analysis: Shin and Kim. Writing original draft: Shin, Kim, and Hong. Writing review and editing: Shin, Kim, and Hong. Critical revision of the article for important intellectual content: Shin, Kim, and Hong. Obtaining funding: Shin. Supervision: Hong.
Funding
This study was funded and supported by 2023 Health Fellowship Foundation of South Korea.
Conflict of Interest:
The authors declare they have no conflicts of interest relevant to the contents of this article.
Ethics Approval
This study was reviewed and approved by the Seoul National University Institutional Review Board, # 2305/003-009.
Consent to Participate
Not applicable.
Consent for Publication
Not applicable.
Data Availability
All model inputs analyzed during this study are included in this published article.
Code Availability
Model developed for this study is available at https://github.com/shinseung67/Cost-effectiveness-analysis/.
Footnotes
Seungyeon Shin and Maryanne Kim have contributed equally to this work.
Change history
8/6/2025
Affiliation 3, assigned to the author Maryanne Kim, was given incorrectly as "Division of Geriatrics, University of California, San Francisco, CA, USA" and has now been corrected to "Division of Geriatrics, University of California San Francisco, San Francisco, CA, USA".
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All model inputs analyzed during this study are included in this published article.