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.ObjectiveTo review the economic impact (for payers) of NASs granted by the European Medicines Agency (EMA) for dimethyl fumarate (DMF), developed by Biogen and approved for multiple sclerosis (MS) as Tecfidera? on 3 February 2014.MethodWe reviewed the available DMF-containing products and identified their indication and price through relevant databases and official Web sites. The economic impact of Tecfidera? on payers’ budgets was calculated assuming NASs was or was not granted. The forecast was identified in Datamonitor.ResultsResults identified four products already containing DMF as the main or unique ac...