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External Reference Pricing Impact of the Integration of the Amnog Discount In The List Price

      Objectives

      In Germany, the AMNOG law replaced free pricing by the early benefit assessment (EBA) since 2011. Manufacturers are free to set new drugs' prices for up to one year after which the price is negotiated between manufacturers and insurers based on the EBA. The negotiated price, that is consistently lower than the one set by the manufacturers, is considered as the official list price since April 1st2014. The objective of this study is to evaluate the potential impact of this new law on the external reference pricing (ERP) in Europe.

      Methods

      A simulation model, developed for the European Commission, was used to simulate ERP’s impact on Boceprevir and Telaprevir prices after five years, following the discount’s inclusion on the official list price in Germany. ERP impact on price was evaluated in Belgium, Czech Republic, France, Germany, Luxembourg, Norway, Slovakia, Slovenia, Sweden, Switzerland, The Netherlands and UK for Boceprevir and in Belgium, Finland, France, Germany, Luxembourg, Norway, Poland, Slovakia, Slovenia, Sweden, Switzerland, The Netherlands and UK for Telaprevir. National policy inputs were obtained from a literature review and consultation of international organisations’ representatives. Prices used at the start of the simulation were obtained from IMS.

      Results

      After five years, the relative price variation of Boceprevir between the scenario with AMNOG discount integrated in the list price and with no discount integrated in the list price was null in Belgium, Luxembourg, Sweden and UK, of -8.1% in the Netherlands, -9.2% in Norway, nearly -10% in Czech Republic, France, Slovakia and Switzerland, and -14% in Slovenia. For Telaprevir, the price variation was null in Belgium, Finland, Luxembourg, Slovenia and the UK, of -0.8% in Slovakia, -2.5% in the Netherlands, -2.9% in Norway, -6.9% in France and -8.6% in Switzerland.

      Conclusions

      Integrating AMNOG discount in the list price impacts significantly the price in European countries due to ERP.