AMNOG auf dem ökonomischen Prüfstand

In 2011, the “The Act on the Reform of the Market for Medicinal Products” (AMNOG) marked a turning point for the reimbursement of new patented drugs. Until then, their exfactory price had been refunded without any benefit assessment for the duration of patent protection. Ever since then this has been limited to a maximum of one year.

At the same time, the AMNOG price regulation is applied: observing the principle of “Money for Value”, the additional benefit of an innovation is firstly determined by comparing it to an existing therapy. Subsequently, a reimbursement amount is agreed on by the national association of health insurance funds and the manufacturer or set by an arbitration board.

Outcome: By the end of 2014 no additional benefit was certified in 60% of the subgroups; 60% of the regulated prices were still below the lowest price of the product in Europe; almost 20% of the launched pharmaceuticals were withdrawn from the German market; and the number of innovations not even launched in Germany increased by 30%.

The AMNOG in its current form turns out to be a hurdle for both availability and provision. The present study reveals the respective reasons and calls for reforms of the governance process. What is the benefit of cheap innovations if they do not reach the patient?