Belgium - New Combined Reimbursement Rules for Personalised Medicines and Companion Diagnostics
The Belgian Official Journal of 5 June 2019 contains two Royal Decrees that create the regulatory framework for the combined reimbursement procedure of personalised medicines and companion diagnostics (“CDx”) in accordance with the tight reimbursement deadlines that apply to medicines but did not previously govern the CDx. As a result, the reimbursement of new CDx (or predictive biomarkers) often lagged that of the associated medicines and resulted in a reimbursement gap.
The new combined reimbursement procedure involves the cooperation of bodies responsible for respectively medicines and CDx in a “Platform CDx” and implies a single Health Technology Assessment of the “package” that consists of the medicine and the predictive biomarker. The Minister of Social Affairs will authorise or reject the package for reimbursement in a single reimbursement decision.
The combined reimbursement procedure will also entail the registration of all reimbursed tests and of the test results. In future, these will allow for more informed policy decisions regarding personalised medicine and the reimbursement of healthcare services in this area.
The modified regulatory framework consists of a new chapter VIII dedicated to personalised medicines in Annex 1 to the Royal Decree of 1 February 2018 governing the reimbursement of medicines. In addition, the list of categories of healthcare services (“nomenclatuur van geneeskundige verstrekkingen”/“nomenclature des prestations de santé”) contained in the annex to the Royal Decree of 14 September 1984 was expanded with a new Article 33ter that will specifically contain a category of CDx and will be updated frequently to reflect technological and scientific developments.
The new rules will enter into force on 1 July 2019.