Within the past 20 years several amendments of healthcare legislation have come into force in Germany, most notably the Act on the Reform of the Market for Medicinal Products (AMNOG). Through its implementation in January 2011, the AMNOG law has introduced a compulsory early benefit assessment of innovative pharmaceuticals for the first time in Germany.
This legislation results in a complex healthcare system entailing a dense regulatory network and close interaction between involved stakeholders. Market access barriers have developed at national and especially at regional level with significant impact on successful market access for pharmaceuticals. The early benefit assessment of pharmaceuticals is legally based on § 35a SGB V and the Rules of Procedure (VerfO) of the Federal Joint Committee (G-BA). The early benefit assessment was implemented for all reimbursable pharmaceuticals with new APIs (active pharmaceutical ingredient) or new API combinations as the mainstay of the new AMNOG legislation. The early benefit assessment procedure has a set structure and lasts regularly for at least 12 months: from time of dossier submission (which is defined by the time of first product launch as well as by the publication of the pharmaceutical price list in the Lauertaxe) until the negotiations of the respective reimbursement price.
The outcome of the early benefit assessment has an influence on companies' decisions to launch drugs in Germany, as well as a potential knock-on effect across Europe, as many other countries use Germany's process in reference pricing. It is essential to choose the right comparator (defined by the G-BA) and get the data that best reflects your drug's benefits, and gain the evaluation that allows you to get market access at the right price point.
To guide you through the market access journey in Germany, visit our Germany Value, Access and Outcomes Planner.
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Essential reading to gain a greater understanding on strategies that are relevant to succeeding in Germany: