TY - JOUR

T1 - The affordability of lecanemab, an amyloid-targeting therapy for Alzheimer's disease

T2 - an EADC-EC viewpoint

AU - Jönsson, Linus

AU - Wimo, Anders

AU - Handels, Ron

AU - Johansson, Gunilla

AU - Boada, Mercè

AU - Engelborghs, Sebastiaan

AU - Frölich, Lutz

AU - Jessen, Frank

AU - Kehoe, Patrick Gavin

AU - Kramberger, Milica

AU - de Mendonςa, Alexandre

AU - Ousset, Pierre Jean

AU - Scarmeas, Nikolaos

AU - Visser, Pieter Jelle

AU - Waldemar, Gunhild

AU - Winblad, Bengt

N1 - Publisher Copyright: © 2023 The Author(s)

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Antibodies against amyloid b-peptide

KW - Health economics

KW - Lecanemab

KW - Mild AD

KW - Passive immunotherapy

KW - Pricing

KW - Prodromal AD

U2 - 10.1016/j.lanepe.2023.100657

DO - 10.1016/j.lanepe.2023.100657

M3 - Review

C2 - 37251789

AN - SCOPUS:85159583413

VL - 29

JO - The Lancet Regional Health - Europe

JF - The Lancet Regional Health - Europe

SN - 2666-7762

M1 - 100657

ER -