The affordability of lecanemab, an amyloid-targeting therapy for Alzheimer's disease: an EADC-EC viewpoint.

Lecanemab, an anti-amyloid antibody with effects on biomarker and clinical endpoints in early Alzheimer's Disease (AD), was granted accelerated approval by the FDA in 2023 and regulatory review in Europe is ongoing. We estimate the population potentially eligible for treatment with lecanemab in the 27 EU countries to 5.4 million individuals. Treatment costs would exceed 133 billion EUR per year if the drug is priced similarly as in the United States, amounting to over half of the total pharmaceutical expenditures in the EU. This pricing would be unsustainable; the ability to pay for high-priced therapies varies substantially across countries. Pricing similarly to what has been announced for the United States may place the drug out of reach for patients in some European countries. Disparities in access to novel amyloid-targeting agents may further deepen the inequalities across Europe in health outcomes. As representatives of the European Alzheimer's Disease Consortium Executive Committee, we call for pricing policies that allow eligible patients across Europe to access important innovations, but also continued investments in research and development. Infrastructure to follow up the usage of new therapies in routine care and new payment models may be needed to address affordability and inequalities in patient access.
Competing Interests: No specific funding was received for the preparation of this manuscript. Authors have completed separate CoI forms. The authors declare the following Conflicts of Interest: LJ received research grants (paid to institution) by Vinnova, FORTE and Novo Nordisk, license fees for the RUD instrument paid to European Health Economics, advisory board honorarium from Laboratoires Servier, travel support from BioArctic AB. AW received grants from Vinnova and EU (PREDEM, MOPEAD, PRODEMOS, EURO-FINGER, PROMINENT, PMI-AD, ADDITION, paid to institution), and is a license holder of the RUD instrument. Member of MSAP for ADI (un-paid). RH received research grants from JPND, ZonMW, IMI, H2020 (paid to institution), consulting fees from Lilly Nederland, iMTA, Biogen Nederlands, Biogen MA Inc, Eisai Inc (paid to institution), member of ISPOR modeling SIG and IPECAD modeling group (un-paid). MB is Member of the Advisory Boards Grifols, Roche, Lilly, Araclon Biotech, Merck, Zambon, Biogen, Novo- Nordisk, Bioiberica, Eisai, Servier, Schwabe Pharma. SE received research grants from Interreg Vlaanderen-Nederland, Research Foundation Flanders (FWO), VLAIO, GSKE/FMRE (paid to institution), consulting fees from Icometrix, Novartis, Eisai (paid to institution), personal consulting fees from Roche and Biogen, personal honoraria from Eisai, Roche, travel support to institution from Biogen, Patent EP3452830B1 (institution), member of SMB/SAB for EU-H2020 project RECAGE. VP of Belgian Dementia Council (unpaid). LF received grants from EU (RADAR-AD, RECAGE, FRAILBRAIN, paid to institution), personal consulting fees from Biogen, Eisai, Grifols, Hummingbird, Infecto-Pharm, Janssen-Cilag, MSD, Neurimmune, Functional Neuromodulation, Noselab, NovoNordisk, Roche, TauRX, Schwabe, lecture honoraria from Hoffmann-LaRoche and Schwabe, personal advisory board honorarium from Avanir/Otsuka, Pharmatropix, FZ Jülich, Charité Berlin, Neuroscios, reMYND, Vivoryon. FJ received personal consulting fees and lecture honoraria from Eisai, Biogen, Lilly, and personal honoraria for participation in advisory board from AC Immune. PJO received grants from Alector, Alzheon, Araclon Biotech, Biogen, Avanir Pharmaceuticals, Cortexyme, Eisai, Eli Lilly, Green Valley Pharmaceutical, Hoffman-La Roche, Janssen, Novartis Pharmaceuticals, NovoNordisk, TauRx, UCB Biopharma (paid to institution). NS received grants from EU (EPAD) and NovoNordisk (paid to institution). Personal fee as member of SAB from Albert Einstein College of Medicine – NIH funded. PJV received grants from EU (AMYPAD, RADAR-AD, EPND), Zon-MW, Biogen, Amyloid biomarker study (paid to institution), honoraria from workshop grant writing by Stiftung Synapsis, Alzheimer Forschung Schweiz. Patent holder (PCT/NL2020/050216) on AD subtypes (all paid to institution). GW received research grant from Danish Ministry of Health (paid to institution). BW received personal honorarium for a 2 h meeting with BioArctic, member of SMB for Alzinova, member of SAB for Resverlogix, stocks in AlzeCure pharma. GJ, PK, MK and AM declare no conflicts of interest.
(© 2023 The Author(s).)