Volker J J Schettler1, Class L Neumann2, Christian Peter3, Thomas Zimmermann3, Ulrich Julius4, Eberhard Roeseler5, Franz Heigl6, Wolfgang Ramlow7, Helmut Blume8. 1. Center of Nephrology Goettingen GbR, Göttingen, Germany. 2. BRAVE - Benefit for Research on Arterial Hypertension, Dyslipidemia and Vascular Risk and Education e.V., Göttingen, Germany. 3. BioArtProducts GmbH, Rostock, Germany. 4. Department of Medicine III, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany. 5. Center for Nephrology, Hypertension, and Metabolic Diseases, Hannover, Germany. 6. Medizinisches Versorgungszentrum Kempten-Allgäu, Kempten, Germany. 7. Apheresis Center, Rostock, Germany. 8. Scientific Institute for Nephrology (WiNe), Düsseldorf, Germany.
Abstract
OBJECTIVE: In recent years the Federal Joint Committee (G-BA), a paramount decision-making body of the German health care system challenged the approval of diagnostic and therapeutic procedures for regular reimbursement, including lipoprotein apheresis therapy. Years before an interdisciplinary German apheresis working group, established by members of both German Societies of Nephrology (Verband Deutsche Nierenzentren (VDN), Deutsche Gesellschaft für Nephrologie (DGfN)), initiated a revision of the indication of lipoprotein apheresis therapy according to current guidelines and recommendations for the treatment of lipid disorders. This working group was convinced, that data derived from a registry would support lipoprotein apheresis as a therapy for severe hyperlipidemic patients suffering from progressive cardiovascular diseases. METHODS AND RESULTS: In 2009 the working group established the indication for lipoprotein apheresis with respect to current cardiovascular guidelines and scientific knowledge for the registry, which are in line with the reimbursement guidelines. In 2011 financing by sponsors was secured and an internet-based registry was created. A pilot project with 5 apheresis centers finished in 2012 - since then the registry is available to all German apheresis centers. CONCLUSIONS: There has been consensus between the medical societies and health care carriers regarding the need for a German Lipoprotein Apheresis Registry (GLAR). The launch of this registry complies with requirements of the Federal Joint Committee (G-BA). Complementing the Pro(a)LiFe-Study, first data from GLAR support the safety of the different apheresis treatment procedures. In addition these first data suggest, with respect to the results of Pro(a)LiFe-Study, effectiveness in preventing cardiovascular progression as well. Here, further data are needed to statistically substantiate these early findings.
OBJECTIVE: In recent years the Federal Joint Committee (G-BA), a paramount decision-making body of the German health care system challenged the approval of diagnostic and therapeutic procedures for regular reimbursement, including lipoprotein apheresis therapy. Years before an interdisciplinary German apheresis working group, established by members of both German Societies of Nephrology (Verband Deutsche Nierenzentren (VDN), Deutsche Gesellschaft für Nephrologie (DGfN)), initiated a revision of the indication of lipoprotein apheresis therapy according to current guidelines and recommendations for the treatment of lipid disorders. This working group was convinced, that data derived from a registry would support lipoprotein apheresis as a therapy for severe hyperlipidemic patients suffering from progressive cardiovascular diseases. METHODS AND RESULTS: In 2009 the working group established the indication for lipoprotein apheresis with respect to current cardiovascular guidelines and scientific knowledge for the registry, which are in line with the reimbursement guidelines. In 2011 financing by sponsors was secured and an internet-based registry was created. A pilot project with 5 apheresis centers finished in 2012 - since then the registry is available to all German apheresis centers. CONCLUSIONS: There has been consensus between the medical societies and health care carriers regarding the need for a German Lipoprotein Apheresis Registry (GLAR). The launch of this registry complies with requirements of the Federal Joint Committee (G-BA). Complementing the Pro(a)LiFe-Study, first data from GLAR support the safety of the different apheresis treatment procedures. In addition these first data suggest, with respect to the results of Pro(a)LiFe-Study, effectiveness in preventing cardiovascular progression as well. Here, further data are needed to statistically substantiate these early findings.
Authors: V J J Schettler; J Ringel; S Jacob; U Julius; R Klingel; F Heigl; E Roeseler; P Grützmacher Journal: Internist (Berl) Date: 2016-05 Impact factor: 0.743
Authors: V J J Schettler; C L Neumann; C Peter; T Zimmermann; U Julius; E Roeseler; F Heigl; P Grützmacher; H Blume; A Vogt Journal: Clin Res Cardiol Suppl Date: 2017-03
Authors: Richard A Ferraro; Thorsten Leucker; Seth S Martin; Maciej Banach; Steven R Jones; Peter P Toth Journal: Drugs Date: 2022-03-18 Impact factor: 11.431