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Orchard Therapeutics Outlines US Launch Plans for Lenmeldy With $4.2M Price Tag

NEW YORK – Orchard Therapeutics on Wednesday announced US commercial launch plans for Lenmeldy (atidarsagene autotemcel), its gene therapy for children with metachromatic leukodystrophy (MLD), for which the firm has set a $4.25 million wholesale acquisition price.

London-based Orchard on Monday announced that Lenmeldy, which has already been approved in the European Union, Switzerland, and the UK as Libmeldy, had been approved by the US Food and Drug Administration. It's the first gene therapy for MLD, a rare genetic disease, to reach the US market.

The $4.25 million price tag reflects the clinical, economic, and societal value of a one-time treatment for MLD, Orchard maintained in a statement. In setting the price, the firm said it considered "the potential long-term impact treatment may have on overall healthcare utilization, minimization of productivity loss for caregivers, and life opportunities for patients."

The Institute for Clinical and Economic Review (ICER), a nonprofit that conducts independent value assessments of healthcare interventions, had suggested that Lenmeldy could be cost-effective if priced between $2.3 million and $3.9 million. Orchard added that it is "working collaboratively" with commercial and government payors to establish outcomes- and value-based risk-sharing agreements.

"We are confident in the potential long-term clinical outcomes of Lenmeldy and will continue to work with public and private payors to structure outcomes-based and other types of innovative reimbursement models that appropriately balance the needs of patients and families for adequate access, healthcare systems for affordability, as well as support future research and development of treatments for ultra-rare diseases like MLD," Orchard President and Chief Operating Officer Frank Thomas said in a statement.

The company, which is owned by Tokyo-based pharmaceutical firm Kyowa Kirin, is setting up a network of qualified treatment centers that will be able to administer Lenmeldy, beginning with five hospitals in Minneapolis, Atlanta, Philadelphia, Houston, and San Francisco. Orchard has also established a patient services program, dubbed Orchard Assist, to connect patients and caregivers with case managers who can support them throughout the treatment process.