Slovenian Health Insurance Institute denies funding for boy's Duchenne therapy in US

The Zavod za zdravstveno zavarovanje Slovenije (ZZZS) has refused to finance a treatment for a Slovenian boy, Tea, who suffers from Duchenne muscular dystrophy. The proposed therapy, Elevidys, would be administered in the United States. ZZZS cited the medical council’s assessment that the drug offers no realistic prospect of cure, improvement, or slowing of disease progression. The council also noted that Elevidys has not received EU marketing authorization and that the phase‑3 EMBARK trial failed to meet its primary endpoint, with two trial participants dying from liver failure.

The council suggested an alternative therapy, duvyzat (givinostat), which received EMA approval in June 2025 and is available in Slovenia. The decision was announced on 24 July, amid an ongoing donor campaign to raise funds for Tea’s treatment.