Comprehensive support with the negotiation of the reimbursement price according to § 130b SGB V
With the GKV Financial Stabilization Act (GKV-FinStG), which came into force in Germany in 2023, the legal framework for negotiating reimbursement prices has become significantly more complex. Further legislative changes are to be expected in the coming months and years. In this dynamic environment, it is important for pharmaceutical manufacturers, with regards to negotiating the reimbursement price, to pursue the optimal strategy from the very beginning of the AMNOG process.
- Extensive analysis of the reimbursement price
We analyze the price potential in the therapeutic indication of your product early on in the AMNOG process. In doing so, we derive scenarios for the negotiation of the reimbursement price based on the costs for possible comparative therapies and the individual study situation.
- Optimal strategy for negotiating the reimbursement price
In close cooperation with you, we develop the best possible strategy for your reimbursement price negotiations. Therefore, we draw on our wealth of experience in price negotiations and extensive knowledge of the German pharmaceutical market.
- Targeted negotiation training
We prepare you specifically for each negotiation date. Together we create a negotiation script and simulate the negotiation situation.
- Effective collaborations
In order to provide you with the best possible support in achieving your negotiation goals, AMS offers to bring in various cooperation partners such as specialized lawyers or an acting trainer as part of the negotiation training.
- Support in the preparation of appendices I-III, IIIa-c for the GKV-SV
We offer support in the preparation of appendices I-III, IIIa-c in accordance with Section 3 of the framework contract.
- Strategic and formal preparation for arbitration procedure
If no agreement can be reached with the GKV-SV during the reimbursement price negotiations, one of the negotiating parties will call the arbitration board. In this case, we will continue to advise you strategically and support you in preparing your concretizing request.
Price negotiation with the GKV-SV linked to the German AMNOG procedure
Since January 2011, the AMNOG has regulated the market access for drugs in Germany. On the basis of a benefit dossier, which the pharmaceutical manufacturer submits when entering the market or upon market authorization of a new therapeutic indication, the G-BA decides on the additional benefit of the drug. Based on this assessment of the additional benefit, a reimbursement price is negotiated between the pharmaceutical manufacturer and the GKV-SV in accordance with Section 130b of the Social Code - Book V (SGB V). The negotiated reimbursement price applies retroactively from the 7th month after the drug has entered the market in Germany or an approval extension has been granted. The possible amount of the (partial) reimbursement price is regulated by a statutory framework based on the additional benefit as determined by the G-BA.