In line with a provisional report issued in September, Boston, USA-based pricing watchdog the Institute for Clinical and Economic Review (ICER) has confirmed guidance on the cost-effectiveness of a new gene therapy.
Approved in the UK and Europe, atidarsagene autotemcel is being developed by Orchard Therapeutics (Nasdaq: ORTX) as a treatment for the rare disease metachromatic leukodystrophy (MLD).
A decision from the US Food and Drug Administration on Orchard’s Biologics License Application (BLA) is expected by March 18, 2024.
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