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@ARTICLE{Pennings:310364,
author = {E. R. A. Pennings and F. W. Thielen and F. Broussais and J.
Delgado and U. Jaeger and C. Sanges and Y. Cabrerizo and L.
Roux-Opstaele and C. Dreuillet and E. Gonzalez-Marcano and
O. Millán and B. Huber and S. Clavreul and N. Bolaños and
S. Nier and J. Mihályová and R. Hájek and M. Horňáková
and R. Doeswijk and C. Thieblemont and M. Hudecek$^*$ and C.
A. Uyl-de Groot and M. J. Kersten},
title = {{T}he {E}uropean {CAR}-{T} map-{C}urrent status and future
directions to improve access to {CAR} {T}-cell therapy for
hematologic malignancies.},
journal = {HemaSphere},
volume = {10},
number = {3},
issn = {2572-9241},
address = {Hoboken},
publisher = {John Wiley $\&$ Sons Ltd.},
reportid = {DKFZ-2026-00560},
pages = {e70306},
year = {2026},
note = {#NCTZFB9#},
abstract = {Despite its great promise, implementation of CAR-T
therapy-a personalized, logistically complex, and expensive
treatment-remains challenging, hampering patient access
across and within countries. Since 2018, six products have
been centrally approved in Europe (i.e., the European
Economic Area; EU-approved) for 15 hematologic malignancy
indications. To better understand patient access to
EU-approved commercial CAR-T therapy, we evaluated the
current status in all 30 countries where EU-approval is
valid plus the UK, addressing economic, clinical, and
organizational aspects, and identifying challenges and
strategies for improvement. A two-step approach was used,
complementing data from marketing authorization holders (4/4
responded) with country-specific insights from clinical
experts obtained via an online survey (30/31 responded). In
August 2024, $26\%$ of the 31 countries had no CAR-T
products commercially available, $74\%$ ≥ 1 product for
non-Hodgkin lymphoma and leukemia, and $16\%$ ≥ 1 product
for multiple myeloma. One-time payment was the most used
reimbursement method. Time to access varied significantly,
with medians ranging from 0 (France/Germany) to 53 months
(Slovakia). The median number of qualified CAR-T centers per
10 million population per country was 5.0 (IQR: 3.0-6.1). In
most countries, patient eligibility assessment was
decentralized. Costs and logistical complexity were main
factors restricting access in countries with and without
commercially available products. Proposed solutions included
cost reductions, improving reimbursement processes, and
increasing healthcare resources. This study shows that
patient access to commercial CAR-T therapy in Europe remains
limited. Its insights into this multi-faceted problem can
guide policy-making, advocacy work, and research to make
this transformative treatment accessible to more patients in
need.},
cin = {WA01},
ddc = {610},
cid = {I:(DE-He78)WA01-20160331},
pnm = {899 - ohne Topic (POF4-899)},
pid = {G:(DE-HGF)POF4-899},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:41799248},
pmc = {pmc:PMC12961523},
doi = {10.1002/hem3.70306},
url = {https://inrepo02.dkfz.de/record/310364},
}