Real‐world lecanemab adoption in Japan 1 year after launch: Insights from 311 specialists on infrastructure and reimbursement barriers

Abstract

INTRODUCTION

Lecanemab was approved for early Alzheimer's disease in Japan, with ≈ 6000 patients treated in the first year post approval. This study explores real‐world practices, challenges, and potential solutions.

METHODS

We conducted an anonymized online survey of clinical specialists authorized to prescribe lecanemab, obtaining responses from 311 specialists who collectively treated 3259 patients with lecanemab.

RESULTS

A majority of respondents (79%) reported wait times of ≤ 3 months from first consultation to initial infusion. One fourth reported tight outpatient space and staffing and significantly lower capacity of treatment than anticipated. Safety concerns were limited, with amyloid imaging‐related abnormality–related interruptions in 3.5%. More than half highly supported additional reimbursement for infusion‐related services and insurance coverage for apolipoprotein E (APOE) testing.

DISCUSSION

Early access to lecanemab appears feasible, yet infrastructure and financial hurdles remain. Dedicated reimbursement and insurance coverage for APOE testing may be essential for ensuring safer, more accessible, and sustainable use of this therapy in Japan.

Highlights

• Results from an online survey of 311 Japanese specialists prescribing lecanemab in its first year are reported.

• Majority of wait times from first consultation to initial infusion were 1 to 3 months.

• Tight affordability of infusion space and staffing was reported by one quarter.

• Establishing additional medical fee for infusion management was highly expected.

• Reimbursement of apolipoprotein E test in Japanese health insurance system was also demanded.

1. INTRODUCTION

Lecanemab (leqembi) ¹ and donanemab (kisunla) ² represent a new era of disease‐modifying therapies (DMTs) for early Alzheimer's disease (AD). As of June 2025, lecanemab is approved in the United States, the UK, EU, Japan, South Korea, mainland China, and other regions; donanemab is approved in the United States, Japan, and the UK. Both drugs have been covered under public health insurance in the United States and Japan, raising hopes for patients with mild cognitive impairment (MCI) or early‐stage AD.

To ensure safe and effective use, appropriate use recommendations (AURs)—which define eligibility and exclusion criteria—have been issued for lecanemab and donanemab in the United States. ³ , ⁴ In Japan, optimal use guidelines (OUGs) for lecanemab (December 2023) ⁵ and donanemab (November 2024) ⁶ closely mirror the AURs while adding requirements under the Japanese national health insurance system.

DMTs remain costly, imposing substantial burdens on patients and public budgets. ⁷ Practical challenges include limited amyloid‐testing capacity, constrained magnetic resonance imaging (MRI) monitoring, management of amyloid‐related imaging abnormalities (ARIAs), and the organization of infusion clinics and staffing. ⁸ Worldwide, > 5 to 6 million individuals in the EU and 2 million in the United States are estimated to be eligible for DMTs, ⁷ , ⁹ with numbers rising as populations age. These factors raise concerns regarding potential shortages in health‐care readiness for DMT treatment provision. ¹⁰ , ¹¹ , ¹² , ¹³ , ¹⁴

By February 2025, ≈ 6800 Japanese patients had received lecanemab infusion under health insurance during the first 13 months post approval. ¹⁵ Recognizing the current real‐world practices of DMT administration and the relevant challenges quantitatively is essential to establishing a more treatment‐friendly infrastructure, we conducted a cross‐sectional online survey to clinical specialists in Japan who are authorized to prescribe lecanemab. We obtained responses from ≈ 300 specialists collectively treating > 3200 patients with lecanemab. The findings from this survey will help inform next steps in improving accessibility and ensuring the sustainable implementation for individuals receiving DMTs for early AD.

2. METHODS

2.1. Study design

We conducted a prospective, cross‐sectional anonymized online survey via Google Forms (https://docs.google.com) from December 2024 to January 2025. This survey was carried out by the FY2024 Ministry of Health, Labour, and Welfare (MHLW) Scientific Research Project titled “A Study on Responses to Social Issues Arising from Advances in Dementia Medicine” in collaboration with the Japanese Society for Dementia Research and the Japanese Psychogeriatric Society. The survey link was emailed to physicians certified in the official training course “Requirements for Administering Anti‐Amyloid β Antibody Therapy for AD,” a 90 minute webinar that explains the drug's efficacy, side effects, administration methods, and how to manage ARIAs, thereby qualifying them to prescribe lecanemab or donanemab under Japan's health insurance system. ⁵ , ⁶ As donanemab was hardly available at the time of this survey, the primary focus was on lecanemab. No personally identifiable information (e.g., name, e‐mail address, or affiliations) was collected.

2.2. Survey architecture

The survey featured 128 questions in total. Because of the branching of the questions, not all questions required responses from every participant. A full English translation of the questions, along with response choices and results, is provided in Table S1 in supporting information. Most items offered single or multiple‐choice responses; some used Likert scales and only a few were mandatory. The questionnaires were designed by the project team members, with the intention of disseminating the findings at academic meetings, in journals, on society websites, and potentially to regulatory authorities.

To maximize participation and responses, the survey comprised three sections (Figure 1): Section 1 (23 questions) collected demographic data and current lecanemab usage status. Section 2 (58 questions) addressed actual practice for eligibility determination, screening tests, genetic testing, and infusion‐related experiences, mainly targeting prescribing physicians. Section 3 (45 questions) explored the adverse event (AE) experiences and the follow‐up procedures for ineligible patients.

FIGURE 1.

Flowchart of questionnaire, composed of three sections. Because the survey includes so many questions, we designed the survey structure with careful consideration to encourage more physicians to respond. Section 1 includes 23 questions, collecting respondent demographics and the current lecanemab usage status. Section 2 includes 58 questions about the current practice for eligibility determination, screening tests, genetic tests, infusions, and the responses of patients and caregivers, asking only physicians who have ever prescribed lecanemab. Section 3 includes 45 questions about the AEs and the follow‐up manner of ineligible patients. The survey URL was e‐mailed to each physician four times in total, corresponding to the entry section to start: physicians were e‐mailed to respond to Section 1 questions on December 23, 2024; to Section 2 questions on December 30, 2024; and to Section 3 questions on January 7, 2025. The final e‐mail was sent on January 21, 2025 as a reminder. Some physicians may respond to Section 2 and/or Section 3 questions only, and some physicians may respond to all questions even when they are asked to respond to Section 1 questions. As a result, ≈ 85% of respondents fully completed the questions of Section 1 through 3, but the remaining 15% of respondents did not answer the questions in Section 1. AE, adverse event; DMT, disease‐modifying therapy

The three sections were e‐mailed separately to physicians on December 23, December 30, and January 7 with a reminder on January 21. Approximately 85% answered all sections; the remaining 15% skipped Section 1. Data collection closed on February 19, 2025.

2.3. Insurance requirements in DMT use

Japan's universal health insurance covers outpatient treatment with lecanemab and associated services, such as infusion administration and brain MRI scans—excluding apolipoprotein E (APOE) testing—on a fee‐for‐service basis as long as the patient meets eligibility criteria determined by the OUG. ⁵ , ⁶ Because these medical expenses—including drug costs—are high, they are usually further covered by the High‐Cost Medical Expense Benefit system, substantially reducing the out‐of‐pocket burden according to household income. Under this program, the annual cap on out‐of‐pocket outpatient expenses for tax‐exempt households is ≈ ≤ $1000. ¹⁶

The survey aligned with OUG, ⁵ , ⁶ , ¹⁷ which mandates three types of strict requirements for administering lecanemab in Japan: patient‐based, facility‐based, and physician‐based requirements. For patient‐based requirements, eligible patients must have no specific brain MRI findings (e.g., vasogenic edema, ≥ 5 microbleeds, superficial hemosiderosis, or brain hemorrhage > 1 cm), have Mini‐Mental State Examination ≥ 22 and Clinical Dementia Rating Global score 0.5 or 1, and have findings indicative of amyloid pathology via positron emission tomography (PET) or cerebrospinal fluid (CSF).

For facility‐based requirements, medical facilities initiating DMT infusions need qualified staff, readily available MRI scanners of which magnetic field strength ≥ 1.5T, and adequate cognitive assessment capabilities. The prescribing physicians must be board‐certified specialists either in neurology, geriatrics, psychiatry, or neurosurgery with ≥ 10 years’ dementia experience who are proficient in reading brain MRI and making decisions about treatment policies, especially in cases of ARIAs. A multidisciplinary team of ≥ 2 full‐time certified physicians, cognitive assessment specialists, MRI experts, and administrative support staff is also required.

Because the risk of ARIA development decreases several months after the initial administration, continued administration at ≥ 6 months can be performed at less stringently equipped facilities.

2.4. Statistical analyses

All statistical analyses were conducted using R. Numerical variables were presented as median (interquartile range [IQR]); categorical variables as counts and percentages (Table S1). Multiple‐choice responses were dichotomized (e.g., “selected/not selected” responses).

RESEARCH IN CONTEXT

1. Systematic review: Lecanemab, a disease‐modifying therapy (DMT) for early Alzheimer's disease (AD), has been administered to ≈ 6800 patients in Japan within the first year of approval. However, real‐world challenges persist regarding health‐care infrastructure, affordability, and logistical readiness. The PubMed database search revealed this study as the first attempt to provide comprehensive insight into these operational and policy barriers by a large‐scale online survey to specialists.

2. Interpretation: The findings from a cross‐sectional online survey in Japan highlight relatively short wait times (typically 1–3 months) for initial infusions and general physician confidence in safety. However, significant issues remain, including outpatient space and staffing shortages, no availability of apolipoprotein E (APOE) testing under health insurance, and financial constraints on infusion management.

3. Future directions: To optimize patient access and long‐term sustainability, policy adjustments may be effective, such as dedicated reimbursement for infusion‐related services and insurance coverage for APOE testing.

The main goal was to examine factors associated with DMT adoption by comparing prescribers (Q13) to reported challenges and solutions (Q127–Q128) using a generalized regression model: $ln(Oddsofchoosingachoiceofinterest)={\beta }_0+{\beta }_{1}User$,

Where “User” indicates whether the respondent has ever prescribed lecanemab (Q13). The exponential of coefficient β₁ corresponds to the odds ratio (OR), which quantifies the magnitude and direction of the difference in opinion between lecanemab users and non‐users. A 95% confidence interval (CI) for the OR that excludes 1 was considered statistically significant.

2.5. Ethics

The current online survey was approved by the University of Tokyo Graduate School of Medicine Institutional Ethics Committee (ID: 2024397NI) under the research title “Survey to Identify Challenges in the Real‐World Use of Anti‐Amyloid Antibody Drugs.” Online informed consent was obtained on the introductory page of the survey form before participants proceeded to the questions. 

3. RESULTS

3.1. Basic demographics

Of the 719 respondents who answered Section 1, approximately half of respondents had ever administered lecanemab (Q13, 46%) (“lecanemab users”). Respondents’ specialties (Q1), as required by the OUG, were neurology (51%), followed by psychiatry (30%), geriatrics (16%), and neurosurgery (15%). Most were also board‐certified dementia specialists (Q8, 85%).

While a majority of respondents’ facilities could not conduct amyloid PET for the eligibility test (Q10, 69%), many were able to conduct CSF testing (Q11, 60%). Most users believed the high cost of lecanemab could pose a financial barrier for patients (Q19, 80%). The average wait time from first outpatient consultation to initial infusion was typically 1 to 3 months (69%, Q20), and ≈ 10% reported ≤ 1 month of wait time. A wait time of ≥ 6 months was reported only by 4.5%.

3.2. Actual practice in lecanemab users

A total of 388 responses were received from specialists who had ever used lecanemab (n = 311, “lecanemab users”) or had entered the survey directly from Section 2 (n = 77). The median number of prescribed lecanemab patients per respondent (Q24) was 4 (IQR: 1–9), summing to 3259 patients in total. The distribution of patients per provider is skewed (Figure S1 in supporting information), suggesting that a subset of specialists and facilities manage a disproportionately large number of patients. Most (≈ 80%–90%) of lecanemab users reported no experience of discontinuing infusions due to ARIAs or other AEs (Q25–Q28). However, 30% had withheld lecanemab use because of a patient's age (Q31), 62% due to concerns about AEs (Q34), and 66% due to the burden of infusion frequency (Q35). Regarding atypical AD symptoms (Q36–Q39), 7% of users had infused patients whose primary symptom was visual, 11% with primarily verbal symptoms, 2% with primarily motor symptoms, and 11% with primarily psychiatric symptoms.

For amyloid confirmation, PET was favored over CSF (Q43, 45% vs. 18%). Some of the lecanemab users had in‐house PET (Q50, 40%), whereas many could conduct CSF tests onsite (Q51, 76%). More than half supported the reimbursement of repeated amyloid testing for monitoring DMT effectiveness (Q55, 55%). Amyloid test results were more often given to patients in face‐to‐face interactions rather than in written documents (Q44, 87% vs. 30%), and most patients or caregivers (≈ 90%) accepted or understood these results to a certain level or above (Q45–Q48). The need of a predetermined protocol in amyloid disclosure was highly recognized by only one third of users (Q49, 35%). The magnetic field strength of the MRI scans performed was similar, with 1.5T accounting for 55% and 3T for 54% (Q56). To detect ARIA with hemorrhages (ARIA‐H), a T2 star sequence was primarily used (Q57, 89%) while susceptibility‐weighted imaging was also used (40%). APOE testing was performed by 28% of users (Q59), of which 76% disclosed the results to patients (Q60). Genetic counseling was available at 62% of these facilities (Q62). Blood‐based biomarkers (BBMs) were seen as a prescreening prior to PET or CSF by 62% and as a potential standalone amyloid test by 27% (Q63).

Approximately half of users had conducted first‐time administration of lecanemab at in‐hospital settings (Q64, 45%). Only one quarter of users reported adequate outpatient space and staffing for infusions, while another quarter described their capacity as “tight” or “exhausted” (Q65, Q66). More than 40% had no affiliated/partner facilities for referring their patients for continued infusions of ≥ 6 months (Q67). Moreover, 62% perceived a discrepancy between supply and anticipated demand for lecanemab treatment capacity at their own facilities (Q68).

On a Likert scale (0–10), users rated lecanemab's efficacy at a median of 6 (IQR: 5–7; Q72) and its performance relative to initial expectations also at 6 (IQR: 5–8; Q73). A certain level of acceptance regarding the infusion route, frequency, cost, and efficacy > 90% among both patients and caregivers (Q74–Q81).

Approximately 40% to 50% of users described the incidence of infusion reactions, ARIA with edema (ARIA‐E), and ARIA‐H as low (Q82, Q84, Q86), with 64% to 71% perceiving these events to occur less frequently than in clinical trials (Q83, Q85, Q87). For ineligible patients (e.g., early‐stage AD, moderate/severe AD, or non‐AD dementia), ≈ 60% of users continued follow‐up for them at an outpatient clinic (Q88, Q101, Q114).

4. CHALLENGES FOR LECANEMAB'S BROADER ADOPTION (IN ALL RESPONDENTS; Q127)

4.1. Economic and efficacy concerns

The most cited barrier was the perception that the drug's benefits do not justify its costs (≈ 55%), followed by concerns over insufficient drug efficacy (≈ 48%) and inadequate insurance coverage for APOE testing (≈ 54%; Figure 2A). Interestingly, while cost–benefit concerns were significantly higher among non‐users (OR ≈ 0.75), experienced users were more likely to highlight practical financial barriers, such as insufficient incentives and reimbursement restrictions for amyloid and APOE testing (e.g., OR ≈ 2.0; Figure 2B).

FIGURE 2.

Perceived barriers to lecanemab's broader adoption by users and non‐users. Perceived barriers to the broader adoption of lecanemab are illustrated in panel (A), and listed from top to bottom in order of highest to lowest selection frequency. Approximately half of both users and non‐users identified several issues and barriers to lecanemab's broader adoption (A): limited efficacy, insufficient incentives to introduce the drug, inadequate outpatient space and staffing, and the lack of an APOE test option under Japan's health insurance system. Comparing users and non‐users (B), outpatient space and staffing deficits were not unique to users (prescribers). However, users were more likely to highlight insufficient incentives, unavailable APOE testing, and limited reimbursement eligibility for amyloid testing (OR > 1). Aβ, amyloid beta; APOE, apolipoprotein E; ARIA, amyloid‐related imaging abnormalities; CSF, cerebrospinal fluid; OUG, optimal use guideline; OR, odds ratio; PET, positron emission tomography

4.2. Clinical and practical barriers

Key practical barriers included the lack of outpatient resources (≈ 45%) and the high risk of side effects, such as ARIAs (≈ 33%). The risk of side effects was a significantly greater concern for non‐users (OR ≈ 0.4). In contrast, users more frequently reported difficulty finding facilities for continued administration, suggesting this is a tangible problem after initiation (OR ≈ 3.0).

4.3. Knowledge and systemic gaps

Barriers related to knowledge and regulations were also noted. Non‐users were significantly more concerned about not meeting initial OUG requirements (OR ≈ 0.3), indicating this is a primary hurdle to starting the treatment. Conversely, users were more likely to identify a lack of understanding among primary care physicians as a barrier. This suggests challenges in coordinating care within the broader health‐care system.

5. POTENTIAL SOLUTIONS FOR LECANEMAB'S BROADER ADOPTION (IN ALL RESPONDENTS; Q128)

5.1. Financial and systemic solutions

Proposals for financial incentives received strong support. More than half of the respondents advocated for public insurance coverage of APOE testing and additional fees for infusion therapy and management (Figure 3A). The need for these financial solutions was significantly more emphasized by lecanemab users compared to non‐users (OR ≈ 2.0–3.0), suggesting that experienced clinicians find the current reimbursement system inadequate (Figure 3B).

FIGURE 3.

Possible solutions to these issues raised by users and non‐users. Possible solutions to these issues are illustrated in panel (A), listed from top to bottom in order of highest to lowest selection frequency. More than half of respondents supported creating a new reimbursement fee for infusion or management, as well as coverage for APOE testing. These suggestions were significantly more common among lecanemab users (prescribers; B). APOE, apolipoprotein E; OUG, optimal use guideline; p‐tau, phosphorylated tau

5.2. Operational and clinical improvements

In terms of clinical practice, improvements to the drug administration route and the implementation of BBMs were widely supported solutions (Figure 3A). Support for these operational improvements was largely consistent across user and non‐user groups.

5.3. Future research and educational imperatives

The promotion of research and development for new drugs was the most endorsed proposal overall. Notably, education for both health‐care and caregiving professionals was considered a significantly more critical solution by users than by non‐users (OR ≈ 1.7–1.9; Figure 3B). This implies that practical experience with lecanemab reinforces the need to enhance knowledge and skills across the entire care team.

6. DISCUSSION

This survey study examined real‐world practices and operational challenges during the first year of lecanemab use by surveying ≈ 300 specialists, who collectively treated ≈ 3250 patients. Our findings highlight the favorable impressions of patient access and the safety profile at the initial rollout of the treatment, while revealing significant areas for improvement in resource allocation and policy support in Japan. As one of the first countries to roll out lecanemab on a large scale under a universal health‐insurance system, Japan's early experience offers valuable lessons for other countries and regions preparing to introduce DMTs.

Although the current survey is anonymized and not exhaustive, its results might have substantial representativeness of all lecanemab‐administering physicians in Japan, because of the number of respondents and the number of their collective patients: as of the current online survey, the estimated total number of Japanese patients who had received lecanemab was ≈ 6800 and the total number of physicians who have ever prescribed lecanemab is estimated at ≈ 1200. ¹⁵ This means the current survey covers ≈ 40% to 50% of infused patients and 25% of lecanemab prescribers in Japan.

One of the most encouraging findings is the relatively short wait time for treatment initiation; most respondents reported a period of ≤ 3 months from the initial consultation to the first infusion. This is better than the estimated wait time in earlier studies; the potential wait times until the initiation of DMT drugs in European countries was estimated to be as long as 1 year. ¹⁰ , ¹⁸ This suggests that the clinical pathways established under Japan's universal health coverage could facilitate timely access to DMT treatment. Abundant MRI capacity (Japan leads the world in scanners per capita ¹⁹ ) might be one of the reasons, as the routine imaging for ARIA monitoring was rarely perceived as burdensome (Q17). The currently short waiting times presumably reflect the limited number of patients during the initial treatment rollout. Maintaining this level of access as the eligible patient population grows will be a challenge. If patient numbers increase to an estimated ≈ 32,000 domestic patients annually in 2031, ²⁰ the resource constraints identified in this survey—such as infusion space and staffing—could become bottlenecks, potentially resulting in longer waiting times.

Safety remains a critical aspect of lecanemab treatment and our survey reflects a generally favorable impression toward safety profile in the real‐world setting. Clinicians reported lower AE rates (Q83, Q85, Q87) and infrequent infusion interruptions due to ARIAs or other events (Q25–Q28) compared to clinical trials. ²¹ The reasons remain uncertain; it may be due to a genuinely low incidence of ARIAs in the Japanese population—similar to the slightly lower ARIA rate observed in analyses on Asian populations from the Clarity‐AD study (e.g., ARIA‐E of 12.6% in overall participants and 6.2% in participants in Asian regions) ²² —or it may result from measurement, recall, and reporting bias. Alternatively, physicians may have applied dosing criteria that were more conservative and cautious than those used in the clinical trials, potentially excluding higher risk patients. While forthcoming registry data from the US ALZ‐NET ²³ and Japan's all‐case post‐marketing surveillance (PI: Takeshi Iwatsubo; https://addmt.ncnp.go.jp) will obtain more detailed and reliable safety data, this survey provided timely, practice‐based insights.

The study also highlights concerns regarding the affordability and logistical demands of administering the therapy and a significant gap between the demand for lecanemab treatment and the capacity available at many facilities. Approximately one fourth of the respondents indicated that outpatient space and staffing for infusion are operating at near capacity (Q65–Q67) that may be a significant barrier to scaling up treatment. In addition, more than half of respondents noted that their current treatment capacity is smaller than what is required (Q68). These results may be related to the possibility that, as inferred from the uneven distribution of treated patients (Q24, Figure S1), cases are heavily concentrated in certain high‐volume centers. Improving the drug administration route, as anticipated by > 50% of users (Q128)—for example, the possible future use of subcutaneous administration of lecanemab, which has been approved in the United States but not in Japan ²⁴ —might reduce burdens such as securing infusion space and staff workload, thereby contributing to improved patient access to the treatment.

The study also reveals challenges related to diagnostic testing. To confirm the findings suggestive of amyloid pathology, PET was preferred over CSF (Q43), although PET is far less available at the users’ own sites (Q50, Q51). The integration of BBMs in prescreening, as expected by the majority of users (Q63), may help ease these resource constraints, reducing dependence on PET and CSF—modalities that are costly, time intensive, or invasive. In Japanese clinical settings, if reimbursed under health insurance as an adjunctive diagnostic aid, BBM measurement may be usefully performed by the patient's primary care physician—for example, avoiding referral to a specialist if the BBM (e.g., phosphorylated tau217 ²⁵ ) level is too low but referring patients when it is in the intermediate range or above—thereby helping to guide the patient's treatment plan.

Policy advocacy may be needed to address these systemic limitations. Lecanemab prescribers (i.e., “users”) have firsthand knowledge of the actual effort, time, and costs involved in the entire process—from explaining the treatment to patients, to preparing and administering infusions, and monitoring for ARIAs. Thus, compared to “non‐users” who lack this direct experience, they are likely to feel more acutely that the current reimbursement levels do not adequately compensate for that effort (Q127, Q128). For example, for a single outpatient visit solely for lecanemab infusion, the hospital can bill the drug cost, infusion procedure fee, and follow‐up consultation fee. Excluding the drug cost, these charges don't even reach USD 10 in total. Because materials such as the infusion line and saline must be paid for out of this amount, the actual profit per patient per outpatient DMT infusion is much lower. Even accounting for the drug price margin, personnel and other expenses can still result in operating at a loss. This is in contrast to other conditions, for which the add‐on fees billable to outpatients are defined by the public insurance schedule: for instance, in the case of administering chemotherapy for malignant tumors on an outpatient basis, hospitals can bill an additional USD 30 to 40 (“Outpatient Chemotherapy Administration Fee”), which evaluates the facility's outpatient infusion system and pharmacist involvement. Another example is the “Designated Intractable‐Disease Outpatient Guidance and Management Fee,” under which routine outpatient visits for neurodegenerative diseases like Parkinson's disease can be billed ≈ USD 18. Establishing additional medical fees for outpatient infusion and for managing relationships with affiliated or partner facilities might be critical measures to help expand outpatient capacity and better support the infrastructure required for DMT provision. In addition, because APOE ε4 allele carriers face a higher risk of ARIAs, APOE testing helps stratify risk when deciding to start treatment and for planning monitoring, thereby improving the quality of informed consent (shared decision making) with patients and their families. This is why insurance coverage of the APOE test is highly anticipated by specialists (Q128).

Our study has some limitations. First, although the collective number of treated patients by the respondents was > 3200, it is possible that the same patient was counted more than once by respondents belonging to the same facility. Second, due to the nature of anonymized online survey, the degree of influence of selection bias on the representativeness of the current results to all users remains uncertain. This should be evaluated by comparing the results from the current survey to those from an all‐case registry.

Based on the findings of this study, the concrete policy recommendations we suggest are as follows: (1) Establish new reimbursement codes: Create dedicated fee‐schedule codes to recognize the full range of administrative and specialized tasks involved in DMT administration (e.g., an “anti‐amyloid antibody treatment management fee”). (2) Expand insurance coverage for mandatory testing: Secure insurance reimbursement for clinically valuable APOE genotyping, with a view to covering plasma biomarker assays in the future. (3) Promote regional care coordination: Design reimbursement incentives that support the development of collaborative care networks between central hospitals and community providers (such as primary care physicians) to ensure seamless continuity of DMT delivery. These measures might be essential for building a sustainable, high‐quality infrastructure for delivering DMTs.

In summary, while lecanemab shows considerable promise as a treatment for early AD, its broader implementation in Japan might depend on addressing the operational and infrastructural challenges suggested in this study. Future efforts should focus on policy adjustments and resource allocations to ensure that the benefits of lecanemab are fully realized in clinical practice while maintaining high standards of patient safety and care.

CONFLICT OF INTEREST STATEMENT

A.I. receives honorarium and a clinical trial grant from Eisai. Other authors have no conflicts of interest to disclose related to the content of the manuscript. Author disclosures are available in the supporting information.

CONSENT STATEMENT

Online informed consent was obtained on the introductory page of the survey prior to questions.

Supporting information

Supporting Information

Supporting Information

Supporting Information

Sato K, Niimi Y, Ihara R, et al. Real‐world lecanemab adoption in Japan 1 year after launch: Insights from 311 specialists on infrastructure and reimbursement barriers. Alzheimer's Dement. 2025;21:e70652. 10.1002/alz.70652

DATA AVAILABILITY STATEMENT

The survey data we used for this analysis are not available for data sharing.