a1 Maastricht University and Agency for Health Technology Assessment in Poland (AHTAPol)
a2 Maastricht University and VU University Amsterdam
a3 Sackler Faculty of Medicine
a4 Maastricht University
a5 VU University Amsterdam; Netherlands Institute for Systems Biology; University of Manchester; and Manchester Interdisciplinary BioCentre
a6 FU Berlin and Max Planck Institute for Molecular Genetics
a7 Maastricht University
Objectives: This article examines the challenges for health technology assessment (HTA) in the light of new developments of personalized health care, focusing on European HTA perspectives.
Methods: Using the example of the Integrated Genome Research Network – Mutanom (IG Mutanom) project, with focus on personalized cancer diagnostics and treatment, we assess the scope of current HTA and examine it prospectively in the context of the translation of basic and clinical research into public health genomics and personalized health care.
Results: The approaches developed within the IG-Mutanom project are based on innovative technology potentially providing targeted therapies for cancer; making translation into clinical practice requires a novel course of action, however. New models of HTA are needed that can account for the unique types of evidence inherent to individualized targeted therapies. Using constructive health technology assessment (CTA) models is an option, but further suitable models should be developed.
Conclusions: Integrative, systems biology-based approaches toward personalized medicine call for novel assessment methods. The translation of their highly innovative technologies into the practice of health care requires the development of new HTA concepts.
(Online publication March 30 2011)
L.B., J.E.L., T.S.I.D.B., B.L., A.B. acknowledge the MUTANOM project, which is funded through the German Federal Ministry of Education and Research (BMBF) as part of the Program of Medical Genome Research (NGFN-Plus) Grant 01GS08105 (IG-Mutanom). A.B., J.E.L., T.S.I.D.B. acknowledge funding from the European Commission, through PHGEN II, Agreement No. 2008 13 02. A.B., J.E.L., T.S.I.D.B., L.B. are in the Research School CAPHRI, Maastricht University. H.W. thanks various EC framework programs (notably the Marie Curie research training network NucSys, BioSim, EC-MOAN, YSBN, UNICELLSYS), NWO-FALW, the BBSRC and EPSRC (BB/C008219/1, EP/D508053/1, BB/F003528/1, BB/F003536/1, BB/F003552/1, BB/I004688/1, BB/I004696/, BB/I00470X/1), and FEBS for support of a range of Systems Biology projects leading to insights expressed here (see also www.systembiology.net/support). L.B. is employed by the Agency for Health Technology Assessment in Poland (AHTAPol). The views expressed in this article are those of the authors, and do not represent an official AHTAPol's position.