Department of Quality of Laboratories, Sciensano, Rue Juliette Wytsmanstraat 14, 1050, Brussels, Belgium.
Rare Diseases Working Group, Belgian National Commission on Clinical Pathology, Brussels, Belgium.
Orphanet J Rare Dis. 2021 Feb 17;16(1):89. doi: 10.1186/s13023-021-01728-1.
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.
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.
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.
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.
比利时罕见病计划的目标之一是通过使用表型测试来改善患者的管理，更具体地说，通过确定用于罕见病的生化分析，开发新的融资条件并建立参考实验室来获得这些测试。
从 2015 年 5 月至 2016 年 8 月进行了一项可行性研究，以选择可融资的生化分析，其中包括应通过参考实验室进行的分析。该选择基于用于罕见病的分析清单以及对比利时临床病理实验室进行的调查（调查每年的分析成本、量、周转时间以及在比利时不可用且外包到国外的测试）。制定并提交给比利时医疗保健当局一份可融资分析、融资方式、参考实验室范围和预算估算的提案。该提案于 2016 年 12 月获得批准后，从 2017 年 1 月到 2019 年 12 月实施。
2019 年，发布了 46 项新的报销条件，并承认了 18 个参考实验室。还与 5 个外国实验室建立了合作关系，以便组织在比利时不可用的 9 项分析的外包和融资。
在临床病理和罕见病方面，这一举措使未报销的分析得以确定，并满足了最关键的财务需求。它还通过建立比利时参考实验室和用于高度特异性分析的外国转诊实验室，以及为这些测试建立永久性监测、质量和融资框架，有助于改善患者的管理。
