German Court to Rule on Terminal Patient's Fight for Unapproved Drug Coverage
German Court to Rule on Terminal Patient's Fight for Unapproved Drug Coverage
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 challenging a court ruling that denies him access to an unapproved medication. The Federal Constitutional Court of Germany will decide on Wednesday, September 13, whether insurers must cover the cost of drugs not authorised for terminally ill patients. The case centres on Translarna, a treatment his health insurer has refused to fund despite its potential to slow the disease's progression.
The plaintiff, born in 2004, lost the ability to walk in 2015 due to Duchenne muscular dystrophy. His legal battle began after AOK Rheinland-Pfalz/Saarland, his health insurer, declined to pay for Translarna. The Rhineland-Palatinate State Social Court initially ruled in his favour, ordering the insurer to provide the drug, citing possible benefits in delaying the disease's advance.
Translarna was approved by the European Medicines Agency (EMA) in 2014 but only for patients who can still walk. Later trials showed limited effectiveness, and the EMA has not extended approval to non-ambulatory patients due to insufficient evidence. The manufacturer's attempt to widen the drug's use failed, leading the Federal Social Court in Kassel to overturn the State Social Court's decision. It concluded that any hope of meaningful impact was unfounded and that drug safety must take precedence, even in fatal cases. The upcoming ruling by the Federal Constitutional Court will determine whether insurers can be forced to fund treatments lacking full regulatory approval. The outcome could affect others with terminal illnesses seeking access to experimental or off-label medications.
The court's decision will clarify whether patients with fatal diseases can legally demand unapproved treatments. If the ruling favours the plaintiff, insurers may face pressure to cover similar cases in the future. The verdict is expected to set a precedent for access to medications beyond their authorised use.