Outcome of joint negotiations for Libmeldy

Belgium, Ireland and the Netherlands jointly agreed to end the negotiation discussions on reimbursement with the manufacturer of Libmeldy, a gene therapy for the treatment of metachromatic leukodystrophy (MLD).

The joint reimbursement process for Libmeldy started with a Health Technology Assessment by Belgium, Ireland and the Netherlands. In December 2022 the three participating countries initiated price negotiations. They came to an aligned position on what would be an acceptable price for this product in all three countries, taking into account many aspects, such as the expected value, uncertainties, and medical need. However, the manufacturer was not prepared to make the product available under the proposed reimbursement conditions.

Members of the Beneluxa Initiative acknowledge that it is very disappointing for patients and all concerned that it has not been possible to reach an agreement with the manufacturer. 

It is the fourth time that Beneluxa countries have jointly negotiated on the price of a therapy. While the most recent negotiations have resulted in a positive reimbursement decision in all participating countries, the negotiations for Libmeldy did not result in an agreement being reached that would support reimbursement in Ireland, Belgium and the Netherlands for this promising but extremely expensive therapy. 

About Beneluxa
The Beneluxa Initiative on Pharmaceutical Policy is a voluntary collaboration between Belgium, The Netherlands, Luxemburg, Austria and Ireland. The cooperation was initiated with the aim of sustainable access to and appropriate use of medicines. Together its members strive to enhance patients’ access to high quality and affordable pharmaceutical treatments. Besides undertaking joint price negotiations, the partnership works together on horizon scanning, health technology assessments and sharing of knowledge and expertise on policies and challenges yet to come.

Last update: 12 April 2023


Ireland, Belgium and the Netherlands complete joint HTA report on gene therapy Libmeldy

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/atidarsagene-libmeldy/
ZIN report: https://www.zorginstituutnederland.nl/publicaties/adviezen/2022/09/27/pakketadvies-sluisgeneesmiddel-atidarsagene-autotemcel-libmeldy

Last update: 11 October 2022