AMNOG

Trainings for Hearings and Negotiations

Focused preparation

Market access and the reimbursement of medicines and medical devices are governed by specific, institutionalized consultations, hearings and price negotiations. These require pharmaceutical companies to prepare thoroughly and specifically . Understanding the relevant context and adapting one’s approach to the situation effectively are essential. This requires not only technical expertise but also strategic negotiation and communication skills. Drawing on our subject matter expertise and practical experience, we provide you with tailored training and consulting to ensure you are fully prepared for these meetings and negotiations.

Strategic training for G-BA consultation meetings

Early and structured consultation with the Joint Federal Committee (G-BA) is a key factor in the success of a benefit assessment. During these consultations the G-BA determines, the appropriate comparator therapy, amongst other things. This represents the core of the comparative benefit assessment. Pharmaceutical companies must apply for an appointment at an early stage, prepare the consultation request in terms of both content and strategy, and submit it to the G-BA 10 weeks before the actual consultation date. The results are communicated in a confidential oral consultation, which allows for discussion, and are subsequently recorded in a written transcript. We provide comprehensive support with the substantive, strategic and formal preparation of your consultation request.

In addition to the written consultation request, the consultation itself requires thorough preparation, clear messaging and an understanding of mutual expectations. We will train you specifically for the consultation with the G-BA and support you in presenting your objectives and content in a structured, consistent and convincing manner. Our training sessions cover refining the substance of your arguments, preparing for critical situations, and and conducting mock consultations. We tailor our training specifically to your company’s products and objectives to ensure you are optimally prepared.

Professional preparation for the G-BA hearing

The early benefit assessment process includes an oral hearing phase that follows the benefit assessment. This phase also includes a the preparation of a written statement. The oral hearing represents the only opportunity, prior to the G-BA’s final decision, to comment on the benefit assessment from the perspective of the pharmaceutical company and interested medical society experts , as well as to request amendments where appropriate. This is why the oral hearing is so importance. In the written statement, you can comment on and discuss the results of the benefit assessment, as well as submit further data where necessary. Comments must be submitted within three weeks of the publication of the benefit assessment. We are happy to assist you in preparing your submission.

Tailored negotiation training

The goal of the early benefit assessment under the AMNOG program is to negotiate a reimbursement rate for new medicines. The legal framework for these negotiations under Section 130b of the German Social Code, Book V (SGB V), is highly complex and subject to constant change. Thorough and strategic preparation for the negotiations is essential to secure the best possible reimbursement rate for your product. With our many years of expertise, we guide you through the entire process and prepare you individually and specifically for your negotiations. In addition to training you on how to negotiate the reimbursement amount under Section 130b of the SGB V, we also train you on how to negotiate discount agreements under Section 130c of the SGB V.

Figure 1: Amendments to Section 130b SGB V since the implementation of AMNOG

From theory to practice

Ideally, voluntary negotiations (e.g. those based on the Harvard model) are ideally win-win situations in which both parties benefit from the outcome. In contrast, negotiations with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband, GKV-SV) regarding the reimbursement amounts under Section 130b SGB V are compulsory and tend to be of a distributive, requiring compromise. Should the negotiating parties fail to reach an agreement, an arbitration board will decide on the reimbursement amount.
Key strategic considerations that determine the strategy and tactics of pharmaceutical price negotiations include exploring the “zone of possible agreement” and the “best alternative to a negotiated agreement.” In addition to intensive preparation, experienced negotiators use negotiation techniques to clarify their objectives and the objectives and motives of the other side.
We are happy to support you with customized training to ensure you are fully prepared for negotiations with the GKV-SV.

Training Concept

The launch price establishes the price benchmark for negotiations with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband, GKV-SV). Negotiations begin with the pricing and market launch, in the form of the price notification and the submission of the benefit dossier. Actual preparation for negotiations with the GKV-SV regarding the reimbursement amount under Section 130b of the SGB V begins with developing a strategy and defining objectives based on prices and quantities of appropriate comparative therapies and comparable medicinal products.. A thorough market and price analysis is essential for the negotiation. In addition to these factual arguments, negotiation skills as well as an understanding of the negotiation process are crucial factors for success. Therefore, Our training program generally comprises the following components:

• Basic knowledge of the framework conditions for negotiations (including contract forms, AMNOG guidelines)
• Strategic advice and definition of objectives
• Market and price analysis
• Specific negotiation skills: negotiation theory and competence, negotiation tactics and personalities, are also covered.

Our expertise is based on game theory, social psychology and negotiation theory. Furthermore, our trainers have practical experience negotiating with health insurance funds and the GKV-SV. We tailor our training programs to our clients’ individual knowledge and interests

Support with price negotiations

We would be happy to support you with our many years of experience negotiating with the GKV-Spitzenverband and/or health insurance funds. Our services include specific training to prepare you for the negotiations (see above). We provide personalized strategic support during the negotiation meetings. We provide strategic support at every meeting, including personalized preparation, follow-up as well as analysis, to help you achieve the best possible outcome.