In July, the U.S. Food and Drug Administration (FDA) announced safety concerns with the gene therapy Elevidys. In light of this, Point32Health will no longer offer coverage of Elevidys, effective for dates of service on or after July 22, 2025.
Previously, Point32Health covered Elevidys for the treatment of Duchenne muscular dystrophy for members of our Harvard Pilgrim Health Care Commercial, Tufts Health Plan Commercial, Tufts Health Direct and Tufts Health RITogether products. On July 22, we retired the Medical Drug Medical Necessity Guideline for Elevidys and halted coverage.
This coverage change comes on the heels of an announcement from the FDA that it placed Sarepta Therapeutics investigational gene therapy clinical trials on hold following three deaths resulting from acute liver failure in individuals treated with Elevidys or the same AAVrh74 serotype that is used in Elevidys.