Karlsruhe rules on medication cost coverage - German Teen's Legal Fight for Life-Extending Duchenne Drug Reaches Top Court

A young man with Duchenne muscular dystrophy is battling in court for access to a life-extending drug. His health insurer, AOK Rheinland-Pfalz/Saarland, has repeatedly refused to cover the cost of Translarna, a medication not fully approved for his stage of the disease. The case has now reached Germany's highest court, with a final decision expected this week.

The plaintiff, born in 2004, lost the ability to walk in 2015 due to Duchenne muscular dystrophy—a rare, genetic condition that typically causes death in early adulthood. His legal fight began when the Rhineland-Palatinate State Social Court initially ruled in his favour, ordering the insurer to provide Translarna. The judges cited 'indication-based, plausible evidence' that the drug might slow the disease's progression.

The Federal Social Court in Kassel later overturned that decision. It argued that drug safety must come first, even in fatal illnesses, and that patients have no right to unapproved treatments. Translarna is EMA-approved for Duchenne patients who can still walk, but its manufacturer failed to extend approval for non-ambulatory cases. The young man's appeal has now reached the Federal Constitutional Court. On Wednesday, the judges will decide whether insurers must fund unapproved drugs when patients face terminal illness.

The ruling will determine whether the plaintiff can receive Translarna through his insurance. It may also set a precedent for future cases involving access to experimental or off-label treatments in Germany. The court's decision is expected to clarify the balance between patient rights and regulatory safeguards.