Nathalie M Vandevelde1,2, Pieter Vermeersch3,4,5, Katrien M J Devreese3,6, Marie-Françoise Vincent3,7,8, Béatrice Gulbis3,9, François Eyskens10,11,12, François Boemer3,13, André Gothot3,14, Viviane O Van Hoof3,15, Carolien Bonroy3,6, Hedwig Stepman3,6, Geert A Martens3,16,17, Xavier Bossuyt3,4, Laurence Roosens3,18, Julie Smet9, Hilde Laeremans19, Ilse Weets3,20, Jean-Marc Minon21, Kris Vernelen22, Wim Coucke22. 1. Department of Quality of Laboratories, Sciensano, Rue Juliette Wytsmanstraat 14, 1050, Brussels, Belgium. nathalie.vandevelde@sciensano.be. 2. Rare Diseases Working Group, Belgian National Commission on Clinical Pathology, Brussels, Belgium. nathalie.vandevelde@sciensano.be. 3. Rare Diseases Working Group, Belgian National Commission on Clinical Pathology, Brussels, Belgium. 4. Department of Laboratory Medicine, UZ Leuven, Leuven, Belgium. 5. Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium. 6. Department of Laboratory Medicine, Ghent University Hospital, Ghent, Belgium. 7. Department of Laboratory Medicine, Cliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels, Belgium. 8. Belgian Fund Rare Diseases and Orphan Drugs, Brussels, Belgium. 9. Clinical Pathology, LHUB-ULB, Université Libre de Bruxelles, Brussels, Belgium. 10. Center of Inherited Metabolic Diseases, Antwerp University Hospital, Edegem, Belgium. 11. Department of Metabolic Disorders in Children, Antwerp University Hospital, Edegem, Belgium. 12. Observatory of Chronic Diseases, National Institute for Health and Disability Insurance (INAMI-RIZIV), Brussels, Belgium. 13. Biochemical Genetics Lab, Department of Human Genetics, CHU of Liege, University of Liege, Liège, Belgium. 14. Department of Laboratory Haematology and Immuno-Haematology, CHU Liège, Liège, Belgium. 15. Department of Clinical Chemistry, Antwerp University Hospital, Edegem, Belgium. 16. VUB Metabolomics Platform, Vrije Universiteit Brussel, Brussels, Belgium. 17. Laboratory for Molecular Diagnostics, AZ Delta Roeselare, Roeselare, Belgium. 18. Laboratory for TDM and Toxicology, University Hospital Antwerp, Edegem, Belgium. 19. Laboratory of Pediatric Research, Free University of Brussels, Brussels, Belgium. 20. Department of Clinical Chemistry and Radio-Immunology, University Hospital Brussels, Brussels, Belgium. 21. Laboratory and Department of Blood Transfusion, CHR de la Citadelle, Liège, Belgium. 22. Department of Quality of Laboratories, Sciensano, Rue Juliette Wytsmanstraat 14, 1050, Brussels, Belgium.
Abstract
BACKGROUND: One objective of the Belgian Rare Diseases plan is to improve patients' management using phenotypic tests and, more specifically, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories. METHODS: A feasibility study was performed from May 2015 until August 2016 in order to select the financeable biochemical analyses, and, among them, those that should be performed by reference laboratories. This selection was based on an inventory of analyses used for rare diseases and a survey addressed to the Belgian laboratories of clinical pathology (investigating the annual analytical costs, volumes, turnaround times and the tests unavailable in Belgium and outsourced abroad). A proposal of financeable analyses, financing modalities, reference laboratories' scope and budget estimation was developed and submitted to the Belgian healthcare authorities. After its approval in December 2016, the implementation phase took place from January 2017 until December 2019. RESULTS: In 2019, new reimbursement conditions have been published for 46 analyses and eighteen reference laboratories have been recognized. Collaborations have also been developed with 5 foreign laboratories in order to organize the outsourcing and financing of 9 analyses unavailable in Belgium. CONCLUSIONS: In the context of clinical pathology and rare diseases, this initiative enabled to identify unreimbursed analyses and to meet the most crucial financial needs. It also contributed to improve patients' management by establishing Belgian reference laboratories and foreign referral laboratories for highly-specific analyses and a permanent surveillance, quality and financing framework for those tests.
BACKGROUND: One objective of the Belgian Rare Diseases plan is to improve patients' management using phenotypic tests and, more specifically, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories. METHODS: A feasibility study was performed from May 2015 until August 2016 in order to select the financeable biochemical analyses, and, among them, those that should be performed by reference laboratories. This selection was based on an inventory of analyses used for rare diseases and a survey addressed to the Belgian laboratories of clinical pathology (investigating the annual analytical costs, volumes, turnaround times and the tests unavailable in Belgium and outsourced abroad). A proposal of financeable analyses, financing modalities, reference laboratories' scope and budget estimation was developed and submitted to the Belgian healthcare authorities. After its approval in December 2016, the implementation phase took place from January 2017 until December 2019. RESULTS: In 2019, new reimbursement conditions have been published for 46 analyses and eighteen reference laboratories have been recognized. Collaborations have also been developed with 5 foreign laboratories in order to organize the outsourcing and financing of 9 analyses unavailable in Belgium. CONCLUSIONS: In the context of clinical pathology and rare diseases, this initiative enabled to identify unreimbursed analyses and to meet the most crucial financial needs. It also contributed to improve patients' management by establishing Belgian reference laboratories and foreign referral laboratories for highly-specific analyses and a permanent surveillance, quality and financing framework for those tests.
Authors: Christine E Miller; Patti Krautscheid; Erin E Baldwin; Tatiana Tvrdik; Amanda S Openshaw; Kim Hart; Danielle Lagrave Journal: Am J Med Genet A Date: 2014-03-24 Impact factor: 2.802