Economic impact of new active substance status on EU payers’ budgets: example of dimethyl fumarate (Tecfidera®) for multiple sclerosis

摘要

BackgroundRecently, collaboration between regulators and payers was set up and was mainly focused on evidence generation along product clinical development. However, neither the regulatory path nor the new active substance status (NASs) was considered. Granting NASs will provide the product with 8 years of data protection and 2 years of market exclusivity during which no generic could enter the market.