Gene Therapy Libmeldy Undergoes Cross-Country HTA In Europe

Cross-country drug access coalition BeNeLuxA is reviewing the costly one-off gene therapy for children with metachromatic leukodystrophy.

Vector of business people sitting at target table brainstorming idea
Orchard's gene therapy Libmeldy could be subject to cross-country price negotiations • Source: Shutterstock

BeNeLuxA, the cross-country initiative in Europe focused on access to medicines, is conducting a joint health technology assessment (HTA) of what is reportedly the world’s most expensive drug, Libmeldy (atidarsagene autotemcel), a gene therapy from Orchard Therapeutics. Joint price negotiations for the product could follow depending on the outcome of the HTA assessment, says the initiative, made up of Belgium, the Netherlands, Luxembourg, Austria and Ireland.

Industry and other stakeholders will be playing close attention to how the assessment plays out and whether joint pricing negotiations follow as the EU moves towards closer collaboration on HTAs and joint clinical assessments. In October, Belgian minister of health, Frank Vandenbroucke, described BeNeLuxA as the “gold standard for voluntary collaborations between member states

BeNeLuxA

BeNeLuxA is the most advanced of several cross-country collaborations in Europe that aim to make access to medicines more sustainable. It comprises Belgium, the Netherlands, Luxembourg, Austria and Ireland.

Areas of cooperation include: horizon scanning, information sharing and policy exchange, health technology assessments, and pricing and reimbursement

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