Karlsruhe rules on medication cost coverage - Germany's Top Court to Rule on Terminal Patients' Access to Unapproved Drugs

Germany's Federal Constitutional Court will deliver a landmark ruling on Wednesday at 9:30 AM. The case centres on whether health insurers must cover the cost of unapproved drugs for terminally ill patients. At the heart of the dispute is a young man with Duchenne muscular dystrophy fighting for access to a medication called Translarna.

The plaintiff, born in 2004, lost the ability to walk in 2015. His insurer, AOK Rheinland-Pfalz/Saarland, has repeatedly refused to pay for the treatment, despite his worsening condition.

The legal battle began when the Mainz Social Court initially rejected the plaintiff's claim. However, the Rhineland-Palatinate State Social Court later ruled in his favour, ordering the insurer to provide Translarna. This decision was overturned by the Federal Social Court, which argued that drug safety regulations must apply even in cases of fatal illness.

Translarna is approved in the EU for Duchenne muscular dystrophy—but only for patients who can still walk. The European Medicines Agency (EMA) rejected an application to extend its use to non-ambulatory patients, leaving those like the plaintiff without approved treatment options. The Constitutional Court will now decide whether the Federal Social Court's ruling violates the plaintiff's constitutional rights.

The case hinges on whether insurers can be compelled to fund unapproved therapies when no other options exist. The outcome could set a precedent for future disputes over experimental or off-label treatments in life-threatening conditions.

The plaintiff's legal team argues that denying access to Translarna infringes on his right to life and physical integrity. The insurer maintains that funding unapproved drugs would undermine regulatory safeguards designed to protect patients.

The Constitutional Court's decision will determine if the plaintiff can finally receive Translarna. It will also clarify whether insurers must cover unapproved treatments in cases of terminal illness when no alternatives are available. The ruling is expected to have wide-reaching consequences for patients and health providers across Germany.