Abstract
BackgroundOne 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.MethodsA 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.ResultsIn 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.ConclusionsIn 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.
Highlights
In Europe, rare diseases are defined as disorders affecting less than 1 patient in 2.000 individuals [1, 2]
In 2009, the Council of the European Union published recommendations addressed to the Member States in order to encourage them to improve the access of patients with rare diseases to high-quality diagnosis, care, treatment, social support and information [2, 8, 9]
This paper describes the approach used to identify and prioritize the biochemical analyses that should be covered by the Belgium public health system, either through traditional reimbursement of clinical pathology tests or through the development of a new system of Reference laboratory (RL) and foreign referral laboratories, as well as RLs’ selection procedure and duties
Summary
In Europe, rare diseases are defined as disorders affecting less than 1 patient in 2.000 individuals [1, 2]. To this date, approximately 8.000 rare diseases have been identified [2,3,4,5]. One of the deliverables of the Belgian action plan for rare diseases, published in December 2013, is to improve the patients’ diagnosis and follow-up [10]. One objective of the Belgian Rare Diseases plan is to improve patients’ management using phenotypic tests and, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
