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Randomized Controlled Trial
. 2025 Jun;32(6):e70197.
doi: 10.1111/ene.70197.

Utility, Costs and Cost-Utility of Amyloid-PET in the Diagnostic Process of Memory Clinic Patients: A Trial-Based Economic Evaluation From AMYPAD-DPMS

Affiliations
Randomized Controlled Trial

Utility, Costs and Cost-Utility of Amyloid-PET in the Diagnostic Process of Memory Clinic Patients: A Trial-Based Economic Evaluation From AMYPAD-DPMS

Ingrid S van Maurik et al. Eur J Neurol. 2025 Jun.

Abstract

Background: Amyloid positron emission tomography (PET) is instrumental in achieving an accurate diagnosis and may help to limit health-seeking behavior. Currently, amyloid-PET is not routinely used in clinical practice due to lack of evidence on cost-utility. We assessed the cost-utility of early versus no amyloid-PET in the diagnostic work-up of memory clinic patients after 6 months.

Methods: We assessed cost-utility of patients enrolled in AMYPAD-DPMS (EudraCT Number: 2017-002527-21) from six European memory clinics and randomized in ARM1; early amyloid-PET, ARM2; no amyloid-PET or ARM3; (amyloid-PET at request of the managing physician). ARM3 was not part of the cost-utility analysis. The EuroQol classification system (EQ-5D-5L), visual analogue scale (VAS), and ICEpop Capability measure for older people (ICECAP-O) were collected at baseline and 6 months. Costs were calculated from cost diaries at baseline, 3 and 6 months. The incremental cost-effectiveness ratio (ICER) was calculated using EQ-5D-5L and a societal perspective.

Results: From April 2018, to October 2020, 844 participants were screened and 840 were randomized (290 ARM1; 270 ARM2 and 280 ARM3). N = 514 (250 ARM1; 264 ARM2) were included in the economic evaluation. Amyloid-PET resulted in higher costs at 6 months (ARM1 vs. ARM2 ∆€1384, bootstrapped 95% CI [7, 2761]). No significant difference in EQ-5D-5L, VAS or ICECAP-O was found. The incremental cost-effectiveness ratio (ICER) was €461,333 per QALY.

Conclusion: Although patients receive an early etiological diagnosis, the cost-utility after 6 months is not favorable for amyloid-PET. The cost-utility will need to be reassessed when considering amyloid-PET to select patients for anti-amyloid biologics.

Keywords: Alzheimer's disease; amyloid‐PET; cost‐utility; early diagnosis.

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Conflict of interest statement

I.S.v.M. received a consultancy fee (paid to the university) from Roche. D.A. received funding by the Fondation Recherche Alzheimer and the Swiss National Science Foundation (project CRSK‐3_196354/1). L.C. has received research support from GE Healthcare (paid to institution). V.G. received research support and speaker fees through her institution from GE Healthcare, Siemens Healthineers and Novo Nordisk. J.‐F.D. reports a patent (European Patent Office 19705763.1–1132) and participating on an advisory board for Biogen Switzerland. P.S. has received consultancy fees (paid to the university) from Alzheon, Brainstorm Cell, and Green Valley. Within his university affiliation, he is the global PI of the phase 1b study of AC Immune, Phase 2b study with FUJI‐film/Toyama and phase 2 study of UCB and phase 1 study with ImmunoBrain Checkpoint. He is chair of the EU steering committee of the phase 2b programme of Vivoryon, the phase 2b study of Novartis Cardiology and co‐chair of the phase 3 study with NOVO‐Nordisk. He is also an employee of EQT Life Sciences (formerly LSP). G.F. is employee of GE Healthcare. R.G. and AS are employees of Life Molecular Imaging GmbH. J.D.G. has received research support from GE Healthcare, Roche Diagnostics and Hoffmann‐La Roche and speaker or consultant fees from Philips Netherlands, Roche Diagnostics, and Biogen. O.G. has received research support from and Hoffmann‐La Roche and speaker fees from Roche Diagnostics. J.L.M.L.: Dr. Molinuevo reported being a full‐time employee of Lundbeck; receiving grants from the EU IMI and La Caixa Foundation; and having served as a consultant or on advisory boards for or given lectures in symposia sponsored by Roche Diagnostics, Genentech, Novartis, Lundbeck, Oryzon, Biogen, Lilly, Janssen, Green Valley, MSD, Eisai, Alector, BioCross, GE Healthcare, and ProMIS Neurosciences. O.G.‐R.: received funding from the Alzheimer's Association (2019‐AARF‐644568) and Instituto de Salud Carlos III (PI19/00117). P.E. reportes receiving grants from Alzheimer's Research UK, Alzheimer's Drug Discovery Foundation, Alzheimer's Society UK, Alzheimer's Association US, Medical Research Council UK, Novo Nordisk, Piramal Life Sciences, and GE Healthcare; being a consultant to Roche, Pfizer, and Novo Nordisk; receiving speaker fees from Novo Nordisk, Pfizer, Nordea, and Piramal Life Science; receiving educational and research grants from GE Healthcare, Novo Nordisk, Piramal Life Science/Life Molecular Imaging, Avid Radiopharmaceuticals, and Eli Lilly; being an external consultant to Novo Nordisk and Cytodyn and a member of their scientific advisory boards; and being editor in chief of Brain Connectivity and serving on editorial boards of other journals, and was funded by the Medical Research Council and now by the Higher Education Funding Council for England (HEFCE). Z.W. reports grants from the EU IMI during the conduct of the study and grant support and consulting fees from GE Healthcare outside the submitted work and received funding from Health Technology Assessment NIHR, Lewy Body Society, and ARUK. Dr. Edison was funded by the Medical Research Council and now by the Higher Education Funding Council for England (HEFCE). F.J. received payment/honoraria from Roche and Lilly. He has participated on a Data Safety Monitoring Board or Advisory Board for AC Immune, Biogen, Roche, Eisai, and Grifols. J.D. reports serving on a data and safety monitoring board for Roche and receiving lecture fees from Biogen outside the submitted work. A.N. received consulting fees from Hoffman La Roche. Patent: US patent alpha 7 nicotinic PET tracer. She is deputy chairman of Wennergren Foundations. F.B. is a steering committee and iDMC member of studies by Biogen, Merck, Roche, and EISAI. He is a consultant to Roche, Biogen, Merck, IXICO, Jansen, and Combinostics. He has research agreements with Novartis, Merck, Biogen, GE, and Roche and is co‐founder of Queen Square Analytics Ltd. His research is sponsored by the NIHR‐UCLH Biomedical Research Centre, UK MS Society, MAGNIMS‐ECTRIMS, EC‐H2020, EC‐JU (IMI), and EPSRC. G.B.F. has received funding through the Private Foundation of Geneva University Hospitals from: A.P.R.A.—Association Suisse pour la Recherche sur la Maladie d'Alzheimer, Genève; Fondation Segré, Genève; Ivan Pictet, Genève; Race Against Dementia Foundation, London, UK; FondationChild Care, Genève; Fondation Edmond J. Safra, Genève; Fondation Minkoff, Genève; Fondazione Agusta, Lugano; McCall Macbain Foundation, Canada; Nicole et René Keller, Genève; Fondation AETAS, Genève. He has received funding through the University of Geneva or Geneva University Hospitals: for IISSs from ROCHE Pharmaceuticals OM Pharma EISAI Pharmaceuticals Biogen Pharmaceuticals and Novo Nordisk; for competitive research projects from: H2020, Innovative Medicines Initiative (IMI), IMI2, Swiss National Science Foundation, and VELUX Foundation. G.B.F. has received consulting fees through his institution from: Biogen, Diadem, Roche. G.B.F. has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events through his institution from: Biogen, Roche, Novo Nordisk, GE HealthCare. The other authors report no financial disclosures or conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Cost‐effectiveness plane and acceptability curve for total costs (A and B) and healthcare only costs (C and D). Red dot indicates ICER. Utilities were based on EQ5D‐5 L index. A.CE plane for total costs, B. CE acceptability curve for total costs, C. CE plane for healthcare costs and D. CE acceptability curve for healthcare costs.

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