Karlsruhe rules on medication cost coverage - German Court to Rule on Terminal Patient's Fight for Unapproved Drug Coverage

A young man with Duchenne muscular dystrophy is taking his fight for life-extending medication to Germany's highest court. The Federal Constitutional Court will rule on Wednesday at 9:30 AM on whether insurers must pay for unapproved drugs in terminal cases. His insurer, AOK Rheinland-Pfalz/Saarland, has repeatedly refused to cover the cost of Translarna, a treatment not approved for his condition.

The plaintiff has been unable to walk since 2015 and is seeking coverage for Translarna, a drug EU-approved only for walking patients with Duchenne muscular dystrophy. His case has moved through multiple courts, with conflicting rulings on whether the insurer should fund the medication.

The Federal Social Court previously ruled against him, stating that drug safety must take precedence even in fatal diseases. This decision blocked coverage for Translarna, despite the severity of his condition. The European Medicines Agency (EMA) has repeatedly found insufficient evidence to support Translarna's use in non-ambulatory patients. In July 2024, the EMA's CHMP reaffirmed its negative opinion, citing limited scientific data. This stance remains unchanged in assessments up to 2025. The Constitutional Court will now decide on an appeal against the Federal Social Court's judgment. Its ruling could set a precedent for future cases involving unapproved treatments in terminal illnesses.

The court's decision will determine whether the plaintiff can access Translarna through his insurer. A ruling in his favour could force AOK Rheinland-Pfalz/Saarland to cover the drug's cost. The outcome may also influence how German insurers handle requests for unapproved medications in similar cases.