Decision on the reimbursement of the orphan drug SCENESSE® for the treatment of erythropoietic protoporphyria (EPP)

Facts

The case concerns the assumption of costs related to the administration of the drug SCENESSE® for the treatment of erythropoietic protoporphyria (EPP) from which the insured person A. suffers. The drug is not included in the list of pharmaceutical specialties and has not been approved by the Swiss Agency for Therapeutic Products (Swissmedic). The conditions for reimbursement by the mandatory health insurance, in particular the examination of its high therapeutic benefit in general and in the specific case, are controversial between the parties.

Considerations

The Federal Tribunal has recognized that the drug SCENESSE® generally has a high therapeutic benefit for the treatment of erythropoietic protoporphyria (EPP), having been approved by the European Medicines Agency (EMA) and in Germany. However, the existence of such a high therapeutic benefit in the specific case of the insured person has not been sufficiently demonstrated on the basis of the medical reports provided. Further investigations are therefore necessary, in particular through a court-ordered…