
Figure 1: Requirements, pros and cons for the confidential reimbursement amount in Germany
Confidential reimbursement amounts are finally available in Germany. However, the medicinal product and the pharmaceutical company must meet several requirements. Above all, the confidential reimbursement amount will only be available for new medicinal products with initial market entry in Germany and for companies with active R&D located in Germany.
Until now, reimbursement prices have been listed in databases in Germany. This allowed the use of the German reimbursement prices in the European reference price system. With the Medicine Research Act (Medizinforschungsgesetz, MFG), there is now the option that pharmaceutical companies can choose to keep the reimbursement price confidential, although this is associated with additional costs for the industry.
This option is available for innovative medicinal products which are assessed in the AMNOG benefit assessment after initial market entry and for which the negotiations with the statutory health insurances (SHI) on the reimbursement amount are concluded between January 1st, 2025 and June 30th, 2028. It is not possible to opt for a confidential reimbursement amount if an already listed reimbursement amount is subject to renegotiation following a re-assessment of the medicinal product. Nevertheless, it is possible that a product with an initially confidential reimbursement amount may remain confidential after a re-assessment.
Two further requirements for a confidential reimbursement amount aim at strengthening Germany as a research location. The first condition is that the pharmaceutical company has a permanent and active research department in Germany. In the case of development cooperations, licensing, or asset deals, it is also acceptable if the research department belongs to the respective cooperation or licensing partner. Beyond that, the second condition requires the pharmaceutical company to maintain relevant own projects (e. g. sponsored studies) and/or cooperations with public research institutions. Projects and/or cooperations must be ongoing; completed projects and/or cooperations will not be accepted. Pharmaceutical companies that do not conduct research in Germany are exempted from the confidential reimbursement amount. Taken together, both requirements aim to strengthen Germany as a research location.
If all requirements are met, the pharmaceutical company can opt for the confidential reimbursement amount. The pharmaceutical company is legally obliged to grant an additional discount of 9% on the negotiated reimbursement amount as a result of confidentiality. The SHI pay the listed price ahead. In consequence, the pharmaceutical company must pay the difference between listed price and the actual confidential reimbursement amount back retrospectively – this also includes the difference in wholesale margin, pharmacy margin, VAT and patient co-payment, if applicable. The difference in VAT may be refunded as part of the tax returns.
The advantages of the confidential reimbursement amount are that the actual reimbursement amount is no longer available for reference by other European countries and that private payers continue to pay the high list price. Among the disadvantages is increased price intransparency in Germany and Europe. Moreover, pharmaceutical companies will incur additional costs due to the additional 9 % discount and the compensation of the price difference. Pharmaceutical companies without research in Germany are completely excluded from the possibility of agreeing confidential reimbursement amounts.
The aim of the MFG is to strengthen Germany as a research location. With the possibility of a confidential reimbursement amount, the industry is offered incentives for research in Germany, which, however, can hardly be quantified in advance, as the reimbursement amounts are essentially determined by the benefit assessment. At the same time, the costs associated with the confidential reimbursement amount (additional rebate, repayments) reduce the appeal of the research incentives. Consequently, these malus regulations are contrary to the actual objectives of the MFG.