Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden

Orchard Therapeutics announced on Feb. 27, 2023 that it has reached an agreement with the New Therapies (NT) Council which will result in reimbursed access to Libmeldy (atidarsagene autotemcel) for all metachromatic leukodystrophy (MLD) patients who fall within the scope of the European marketing authorization in Sweden.

The agreement with NT Council is a key component of the company’s commercial expansion plans in Europe and follows similar arrangements made with reimbursement authorities in the United Kingdom, Italy, and Germany. Additionally, the company is qualifying a sixth treatment center in Europe at the University Hospital Skåne Lund in Sweden, intended to serve as the primary site for eligible patients referred from the country and the Nordic region.

Libmeldy received the strongest possible recommendation for use by the NT Council following the completion of a health economic evaluation by FINOSE, a health technology assessment consortium between Finland, Norway, and Sweden.

“Libmeldy has the potential to transform the lives of eligible children with a single administration and was approved by the European Commission for the treatment of early-onset MLD based on data now encompassing more than 10 years of follow-up in the earliest treated clinical trial patients,” said Robin Kenselaar, senior vice president, EMEA at Orchard Therapeutics, in a company press release. “We are encouraged that the reimbursement agreements secured in multiple European countries to date continue to recognize the value of Libmeldy commensurate with its clinical impact. The agreement with NT Council is a positive step toward enabling access for MLD patients in other Nordic countries. We look forward to continuing to work with reimbursement authorities in the Nordic region and throughout Europe to make Libmeldy available to patients who may benefit from treatment.”
Source: Orchard Therapeutics