Preparing the pricing strategy for Germany

Novel medicinal products which are launched on the German market after regulatory approval undergo a dossier-based benefit assessment by the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA), known as the AMNOG procedure. For the first six months after market launch, the so-called "free pricing period", the legislator allows a freely selectable launch price to be set that is fully reimbursed from the first day. Subsequently, the reimbursement amount is negotiated with the German National Association of Statutory Health Insurance Funds (GKV-SV), which often means a reduction of the price by a discount adjusted primarily to the outcome of the benefit assessment. The launch price therefore prejudices the amount reimbursed by the Statutory Health Insurance (SHI) funds in the long term. What is a fair price for all involved stakeholders - the SHI, the treatment providers and, of course, the pharmaceutical company, for which the price must also be profitable or adequate?

It is advisable to initiate and prepare the pricing strategy at an early stage. Experience of the complex price relationships at national but also international level is essential for the company's business case. Complemented by in-depth expertise of German Health Technology Assessment (HTA) requirements, a comprehensive and convincing pricing rationale can be developed. Especially for German market newcomers and for extremely innovative or complex therapeutic approaches, such as orphan drugs or gene therapies, the support of an experienced strategic sparring partner is essential to pave the way for successful market access in Germany.

The business case is not won at the negotiating table alone. At SKC, we think from the end of the process and anticipate possible challenges and solutions right from the start. SKC systematically decodes the various framework conditions, influencing factors, intrinsic & extrinsic references as well as precedents & analogues, which can be captured with the help of our own MAIS database. The analyses are harmonized with internal guidelines and also attitudes and translated into transparent, realistic, and justifiable scenarios. This gives pricing managers full decision-making certainty in order to define an optimal price point.

1. Generation of a holistic product understanding. Essential are, for example, the field of application, the available evidence, and the previous market presence in Europe.
2. Detailed analysis of the national and international market situation (e.g. standard of care, unmet medical need, price structures, pipeline) and the legal framework (AMNOG process, price anchors, orphan privileges, etc.).
3. Establishing realistic and justifiable price scenarios considering the benefit assessment, in order to show the opportunities and risks of different courses of action.
4. Exploring the external view of the price, shaped by payers and service providers, in order to anticipate counter-arguments and positions at an early stage.
5. Development of a convincing value story that carries the price value argument and takes the German HTA system into account.