Asian Journal Of Social Pharmacy

Abstract: Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical insurance. Methods A case analysis method was used to introduce the EU’s decision to include rare disease drugs in medical insurance by using real-world evidence because clinical data of rare diseases were difficult to obtain. Results and Conclusion
China can use real-world evidence to make medical insurance decisions based on the experience of the EU and continue to invest more in rare diseases, which can solve the problem of few drugs for patients with rare disease.

Key words: EU, real-world evidence, rare disease, medical insurance