Simon-Kucher's AMNOG experts Gabor Kiss, Christoph Engelke, and Benedict Biebl share insights into what drives successful AMNOG price negotiations – from early strategic decisions to negotiation tactics and execution.
German AMNOG price negotiations start long before the first negotiation round with the GKV-SV. Strategic decisions made well ahead of launch – from evidence generation and dossier strategy to launch pricing – can shape the subsequent benefit assessment and significantly influence the achievable reimbursement price. Understanding these interdependencies and anticipating their implications for price negotiations is critical.
Translating early preparation into a successful negotiation outcome requires a clear strategy, a thorough understanding of the GKV-SV's negotiation approach, and the ability to adapt tactics as discussions evolve. Importantly, the implications of today's decisions often extend beyond the initial negotiation, affecting future indication extensions, renegotiations, and international pricing.
We spoke with Gabor Kiss and Christoph Engelke, Partners at Simon-Kucher and co-leads of the firm's AMNOG team, and Benedict Biebl, Senior Director, about what really matters when navigating the German AMNOG process – and which aspects pharmaceutical companies frequently underestimate. The team has supported more than 150 price negotiations and over 25 arbitration board proceedings in Germany, across therapeutic areas, ranging from blockbuster oncology products to highly specialized orphan drugs and gene therapies.
Where does preparation for a successful AMNOG negotiation actually begin?
Gabor: Much earlier than many companies might expect. In my experience, some of the most important decisions are made well before launch. The evidence strategy, how the added benefit is derived, the positioning against relevant comparators, and even seemingly simple things like how the eligible patient population is derived and how treatment costs are presented can all have a significant impact on the subsequent price negotiation. The key is to anticipate these implications early and approach the entire AMNOG process with the eventual price negotiation in mind.
Christoph: Absolutely. And when it comes to the actual negotiation preparation, it is very important to understand what really drives the achievable price. We analyze relevant price benchmarks, comparable AMNOG cases, the applicable legal and regulatory framework, as well as the key negotiation levers for the product. From there, we define clear objectives, realistic price scenarios, and a strategy for how to achieve them. A target price alone isn't a strategy – you need to know how you are going to get there.
How far ahead do you plan? Are you thinking about the first round, or the whole process?
Christoph: We definitely think about the whole process, including the possibility of ending up before the arbitration board if no agreement can be reached. Every negotiation round needs to serve a purpose. We think through the likely positions of the GKV-SV, anticipate potential objections, and define how we want to move the negotiation forward from one round to the next. But that does not mean following a rigid script – quite the opposite. You need a clear plan, but also the flexibility to react to what actually happens at the negotiation table.
Benedict: One important consideration is that arbitration should not be treated as something to prepare for only after negotiations have failed. The possibility of arbitration needs to be reflected in the negotiation strategy from the beginning.
This means understanding which arguments and supporting analyses could remain relevant in arbitration, where the key uncertainties lie, and how different negotiation outcomes compare with a potential arbitration decision.
Ultimately, manufacturers need a clear view of their alternatives. That puts them in a stronger position to make informed decisions throughout the negotiation process, including when to hold firm, when to compromise, and when arbitration may be the better option.
Strategy is one thing, but negotiating teams are under real pressure at the table. How do you make sure the plan holds up?
Gabor: We develop detailed negotiation guidelines covering everything from key arguments and objection handling to how we want to steer the discussion – even specifying which points should be captured in the negotiation protocol and at what level of detail. Our prior experience with GKV-SV helps us anticipate its arguments and prepare accordingly.
Benedict: That’s exactly where realistic negotiation simulations become valuable. It is one thing to have a well-prepared argument, but quite another to defend it when challenged. These mock negotiations often reveal weaknesses that are difficult to spot on paper: arguments that are less convincing than expected, inconsistencies between team members, or situations where a seemingly harmless concession could undermine the broader negotiation position. Identifying these risks beforehand allows us to refine the strategy and prepare the team for the pressure of actual negotiations.
After each negotiation round, how do you decide whether to hold your position or adjust your approach?
Christoph: One of the most important things is not to confuse a tough negotiation with a failing strategy. The GKV-SV may challenge an argument or push for significant price concessions, but that does not necessarily mean you should adjust your position.
The real challenge is distinguishing between negotiation tactics and signals that genuinely change your assessment of the achievable outcome. You need to know where you have room to maneuver, which concessions might be acceptable, and where holding your ground is critical. That requires a clear strategy upfront, but also the experience to interpret what is happening at the negotiation table.
Looking beyond the initial price negotiation, what do you think manufacturers tend to underestimate?
Gabor: I think one of the most underestimated aspects is how much a product's pricing potential can change over its lifecycle. Orphan drugs are a good example. They initially benefit from special rules, such as automatic added benefit in the AMNOG assessment. But once the statutory revenue threshold is exceeded, they must undergo a regular benefit assessment, which can lead to a substantially different added benefit rating and affect the renegotiation of the reimbursement price.
The important question is therefore not only what price you can achieve today, but how robust that price will be under different future scenarios.
Christoph: And the same applies to indication extensions, competitor entries, or changes in the appropriate comparator therapy. These developments can completely change the negotiation dynamics. That is why we do not look at AMNOG as a one-off event. You need to anticipate how the market and regulatory environment might evolve and understand what that means for your pricing strategy. Otherwise, you risk making decisions today that may become very costly later on.
The latest AMNOG reform has brought several changes to pricing and reimbursement in Germany. Which of these do you consider particularly relevant for pharmaceutical manufacturers?
Gabor: The removal of the pricing guardrails is certainly a positive development for manufacturers, creating new opportunities in price negotiations for certain products. But that does not mean higher prices are automatically guaranteed. For products already on the market, manufacturers need to carefully assess whether renegotiating an existing agreement actually makes sense. The potential upside must be weighed against other factors, including changes in the competitive environment and the new statutory price-volume rules.
This last factor, in particular, should not be underestimated. Some of the largest products could face double-digit price-volume discounts under the new rules, putting significant pressure on their reimbursement prices.
Christoph: Another important change is the increase in the mandatory manufacturer rebate from 7% to 15.5% as of January 1, 2027, with exemptions already in place for certain new launches and further exceptions under discussion.
What makes this particularly interesting is how different rebate levels could affect relative pricing. At first glance, an exemption seems to offer a clear financial advantage. But will manufacturers actually retain that benefit, or could it be partially or fully offset in the negotiated reimbursement price?
That remains to be seen. But it illustrates a broader point: in AMNOG, the impact of a regulatory change cannot be assessed in isolation. What ultimately matters is how the different rules interact and influence the price a manufacturer can achieve.
Simon-Kucher's AMNOG team brings more than a decade of deep analytical, clinical, and economic expertise with direct hands-on execution. Depending on the situation, we work as a strategic sparring partner, an active contributor at the negotiation table, or negotiation lead for our clients to help secure robust, sustainable outcomes in the German reimbursement market.
Preparing for a launch, a dossier, or your next negotiation round? Reach out to our AMNOG team for specialist advice.
