Pricing & Reimbursement
Comprehensive support with the negotiation of the reimbursement price negotiation according to § 130b SGB V
With the introduction of the GKV Financial Stabilization Act (GKV-FinStG), the Act to Combat and Improve the Supply of Medicines (ALBVVG), and the Medical Research Act (MFG), the legal framework for reimbursement negotiations under Section 130b SGB V has evolved significantly in recent years, becoming increasingly complex.
In this dynamic environment, it is more important than ever for pharmaceutical companies to pursue an optimal strategy for reimbursement negotiations from the very beginning of the AMNOG process.
Dr. Alexandra Carls
Director Medical Science
Alexandra is a board-certified specialist in Clinical Pharmacology with extensive expertise in early clinical development, Health Technology Assessment (HTA), and Market Access. She began her career at the University Hospital Heidelberg, where she served as an investigator and principal investigator for Phase I and II clinical trials, ensuring scientific and regulatory excellence in early drug development. Additionally, she gained experience in pediatric nephrology and coordinated the European Reference Network for rare kidney diseases. A research fellowship in Clinical Pharmacology and Toxicology at the Hospital for Sick Children in Toronto further enriched her scientific profile.
Building on this experience, Alexandra transitioned 2016 into HTA and Market Access, leading teams in pricing negotiations, HTA consultations, and dossier preparation. She supports both companies focused on the German market and those requiring a pan-European market access strategy and aligning early development programs with long-term strategic goals. As Director Medical Science, she and her team drive the targeted advancement of the department and the company while fostering long-term client relationships.
Your service expert
Dr. Alexandra Carls
Director Medical Science
Our services include
Comprehensive pricing potential analysis
We conduct early-stage analysis, potentially even before the AMNOG process begins, to assess the pricing potential of your product in relevant therapeutic indications.
Drawing on the available evidence, possible outcomes of health technology assessment, and the costs of potential comparator therapies, we develop strategic scenarios to support reimbursement negotiations.
Leading the negotiations
AMS offers comprehensive expertise in Pricing & Reimbursement – ranging from strategic consulting to negotiation management. With experience from nearly 30 reimbursement negotiations with the German National Association of Statutory Health Insurance Funds, we draw on a wealth of knowledge from various health technology assessment scenarios, including innovative contracting models. This breadth of experience ensures you receive the best possible support with a comprehensive view of the entire market access process.
Tailored strategy for successful reimbursement negotiations
Together with you, we develop the optimal strategy for your negotiation with the German National Association of Statutory Health Insurance Funds – well-founded, thoughtful, and aligned with your market access strategy. We draw on our extensive experience in pricing negotiations and in-depth expertise in the German pharmaceutical landscape.
Advanced negotiation training and legal advice
To provide optimal support in achieving your negotiation goals, AMS offers the option of incorporating specialized partners into the negotiation training process. This could include expert attorneys or a professional actor for realistic role-playing and personalized coaching.
Targeted negotiation training
We prepare you thoroughly for each negotiation meeting. Together, we define key focus areas, after which our team develops a tailored simulation script and rehearses the negotiation scenario with your team. Following each negation meeting, we conduct a comprehensive analysis to refine your approach.
Support in document preparation for pricing negotiations
We are happy to assist you with the preparation of documents in accordance with § 3 of the Framework Agreement (RahmenV), ensuring all required materials are prepared efficiently and in compliance with regulatory standards.
Strategic and formal preparation for arbitration
If an agreement cannot be reached during the reimbursement negotiations with the German National Association of Statutory Health Insurance Funds, one of the negotiating parties may refer the matter to arbitration. In this case, we continue to provide strategic advice and assist you in preparing your detailed application for the arbitration process.
Tailored strategy for successful reimbursement negotiations
Together with you, we develop the optimal strategy for your negotiation with the German National Association of Statutory Health Insurance Funds – well-founded, thoughtful, and aligned with your market access strategy. We draw on our extensive experience in pricing negotiations and in-depth expertise in the German pharmaceutical landscape.
Thanks to our holistic approach, you benefit from a coordinated team that supports your product from the very first step of the AMNOG process. Our experts are deeply familiar with your value story, evidence base, and the nuances of the benefit assessment procedure, ensuring we’re fully prepared to navigate every challenge of the price negotiation with confidence and precision.
Pricing negotiations with the German National Association of Statutory Health Insurance Funds (GKV-SV)
Since January 2011, the AMNOG (Pharmaceuticals Market Access Act) has governed the market access for medicines in Germany. Based on a benefit dossier submitted by the pharmaceutical company upon market entry or the approval of a new therapeutic indication, the Joint Federal Committee (G-BA) assesses the medical added value of the medicine. This assessment of added value serves as the basis for negotiating a reimbursement amount between the pharmaceutical company and the German National Association of Statutory Health Insurance Funds (GKV-SV) in accordance with § 130b of the Social Code (SGB) V.
The agreed reimbursement amount is retroactively applicable from the seventh month after the medicine is placed on the market or after an approval extension. The level of (partial) reimbursement amounts is determined by a legally defined framework, based on the added value as established (or not established) by the G-BA.
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