What is a rare disease?
In Switzerland, a rare disease is defined as a life-threatening or chronically debilitating condition that affects less than 5 in 10,000 people. There are between 6,000 and 8,000 rare diseases identified worldwide, with 75% affecting children and 80% having a genetic origin.
Swiss policy on rare diseases
The limited number of patients per disease and the inherent challenges for research and drug development mean that special incentives are required to support the development of orphan drugs. Accordingly, various incentives such as a simplified authorization procedure and provisions for data exclusivity have been introduced over recent years in Switzerland.
Patient access to diagnosis and treatment of rare diseases in Switzerland
In Switzerland, orphan drugs authorized by Swissmedic are reimbursed by compulsory health insurance if they are included in the Specialties List (SL) established by the Swiss Federal Office of Public Health, or FOPH (Bundesamt für Gesundheit, or BAG / Office Fédéral de la Santé Publique, or OFSP). Orphan drugs that are not included in the SL can be reimbursed via an alternative pathway, art. 71a-d of the Swiss Ordinance on Compulsory Healthcare (Verordnung über die Krankenversicherung, or KVV / Ordonnance sur l’assurance-maladie, or OAMal), if they fulfill certain criteria. In December 2020, the BAG published an evaluation report on this regime.
The report underlines the important role played by this regime in reinforcing patient access to treatment but also highlights several shortcomings in the implementation of the KVV provisions, including the divergence in benefit assessments of treatment options by insurers (the RDAF submitted a statement on the report and the policy options to revise the regime).