ZZZS denies funding for boy Tea's US treatment

Slovenia's national health insurer, ZZZS, has rejected a request to fund experimental treatment for 10-year-old Tea, who suffers from Duchenne muscular dystrophy. The treatment, involving the drug Elevidys, was sought in the United States. The ZZZS cited a lack of expected improvement or prevention of disease worsening as the primary reason for denial.

The decision, issued on July 24, comes amid an ongoing public donation campaign for Tea. A council of doctors at the University Medical Centre Ljubljana's Pediatric Clinic concluded that alternative treatments are available within Slovenia. They suggested Duvyzat, a drug approved by the European Medicines Agency in June 2025, could potentially slow the progression of Tea's condition.

In evaluating Elevidys, the medical council meticulously reviewed clinical trial results. They noted that the EMBARK Phase 3 study did not meet its primary endpoint, showing no statistically significant difference in muscle function between children receiving Elevidys and those given a placebo after 52 weeks. The council also highlighted that the European Medicines Agency had not yet granted marketing authorization for Elevidys in the EU due to insufficient efficacy evidence. Furthermore, two children in clinical trials for the same drug reportedly died from liver failure.

The council expressed additional concerns regarding the gene therapy's use of a viral vector, questioning its unproven effectiveness and the potential to hinder future use of similar, more effective gene therapies. They pointed out that Elevidys is not administered anywhere in the EU, nor is it funded in Italy for Italian children with Duchenne muscular dystrophy seeking treatment in the US. The ZZZS stated that the legal representative later requested the inclusion of foreign experts in the council, proposing three specialists from the US and Canada.