Elevidys’ Restricted Label Helps Sarepta Pressure Payers For Coverage Of DMD Gene Therapy

Sarepta says the age limit in the indication could encourage swifter insurance coverage of the newly approved gene therapy for Duchenne muscular dystrophy so potential patients don't age out of the treatment window before they would be eligible for reimbursement.

Sarepta website
The initial accelerated approval of Elevidys restricted use to four- and five-year-old ambulatory DMD patients. • Source: Shutterstock

A restricted label can often be an impediment to reimbursement, but Sarepta Therapeutics, Inc. is hoping that the limits on Elevidys, its new gene therapy for Duchenne muscular dystrophy, will pressure payers to set reimbursement policies quickly so no eligible boys age out the treatment window before being able to get coverage.

Key Takeaways
  • Sarepta will push for reimbursement so boys don’t age out of restricted Elevidys label

  • The company said conversations with payers have been positive

  • Elevidys

Elevidys (delandistrogene moxeparvovec-rokl) received an accelerated approval from the US Food and Drug Administration on 22 June for four- and five-year-old ambulatory

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