The first step in the joint reimbursement process for Libmeldy® (atidarsagene autotemcel), a gene therapy product for the treatment of children with metachromatic leukodystrophy, was successfully completed. The authors of the pharmacotherapeutic evaluation were RIZIV-INAMI Brussels, and the pharmacoeconomic and budgetary assessment for the three countries (Ireland, Belgium and the Netherlands) was conducted by NCPE in Dublin. ZIN, Amsterdam, contributed as co-author and DSV, Vienna, as reviewer.
Cross-border consultations resulted in a scientific and economic report, approved in all three countries where the company submitted the dossier. This will facilitate agreement on reimbursement terms and be the basis for joint negotiations should the company and the Beneluxa Initiative decide to enter into such a process.
NCPE summary: https://www.ncpe.ie/drugs/otl-200-autologous-cd34-cells-encoding-arylsulfatase-a-arsa-gene-libmeldy-hta-id-21009/
ZIN report: https://www.zorginstituutnederland.nl/publicaties/adviezen/2022/09/27/pakketadvies-sluisgeneesmiddel-atidarsagene-autotemcel-libmeldy
Last update: 11 October 2022