Following the launch of the first disease-modifying therapies for Alzheimer’s disease, a key theme at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases has (AD/PD) been on their real-world use. Eisai/Biogen’s Leqembi was fully approved in the US in July 2023, and Eli Lilly’s Kisunla was approved in July 2024 in the US. With its earlier launch, much of the real-world data at AD/PD 2025 has focused on Leqembi.
Due to the risk of amyloid-related imaging abnormalities, magnetic resonance imaging (MRI) scans are a key component for the safe administration of the anti-amyloid-beta monoclonal antibodies (mAbs), and they were anticipated to be a bottleneck for uptake of the drugs in a clinical setting. During a symposium on ‘Aβ-targeting therapies’ held on 3 April, real-world data of Leqembi use in the US was presented. The data showed that on average there were no significant delays in MRI scheduling for patients who were being prescribed Leqembi, indicating that, despite concerns, the initial drug roll-out has not faced problems with the MRI requirements. However, this is very early data from after the drug was approved and as such, relatively small numbers of patients were being prescribed Leqembi compared with the potential treatable population, so significant logistical and structural changes will still need to be implemented to enable more widespread uptake of these mAbs without MRI requirements resulting in interruptions to dosing.
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Further, the US study highlighted the concerns regarding access, with 98.3% of patients prescribed Leqembi based in an urban setting and 77.4% of a White ethnicity, showing that significant work remains for access for rural and non-White populations. Additionally, the study showed that the majority of patients receiving Leqembi were diagnosed with mild AD, compared with mild cognitive impairment (MCI). In general, the anti-Aβ mAbs are more effective the earlier in the disease progression they are administered, so the results show that more work is also required to increase awareness of MCI so that patients can receive treatment earlier. In an industry symposium sponsored by Eisai on 4 April, further insights on Leqembi use in treatment centres were presented with perspectives for the UK, Israel, and the US. In the UK, while Leqembi has been approved, it is not reimbursed, requiring patients to pay out of pocket for the drug. A similar situation exists in Israel, with patients either paying out of pocket for the drug or accessing it through private healthcare insurance. In general, the experience of Leqembi prescription in the UK- and Israel-based practices was positive, with coordination between many disciplines, such as psychiatrists, radiologists, and infusion centre staff, critical in the smooth implementation of this new way of treating AD. In these private practices, relatively short time periods were seen between patient presentation at the clinic and initiation of Leqembi if criteria for therapy were met. However, these experiences are in private specialised clinical practices and the experience in larger public healthcare services is likely to be different. For example, in the case study of a particular patient’s journey in the US presented during the symposium, there were 20 months between the initial presentation of the patient to primary care and the initiation of Leqembi.
Further real-world insights from more varied clinical practices in broader patient populations will be critical to provide input to enable better implementation of the anti-Aβ mAbs. Longer-term real-world data will also be important to evaluate the efficacy of extended Leqembi use. Questions remain regarding the continued maintenance dosing of Leqembi, with no specified treatment end, compared with the current Kisunla label, which specifies considering stopping treatment once sufficient amyloid clearance is seen. Longer-term data will also allow for continued understanding of the safety profile of the anti-Aβ mAbs as greater uptake is seen.
