Germany – Pharmaceutical products – Abschluss einer nicht-exklusiven Rabattvereinbarung nach § 130a Abs. 8 SGB V über Arzneimittel mit dem Wirkstoff Denosumab Xgeva (ATC-Code nach WHO: M05BX04)

The subject of this publication is the conclusion of non-exclusive discount agreements in accordance with § 130a (8) SGB V for medicinal products with the active substance Denosumab (ATC code according to WHO: M05BX04), limited to products with the trade name Xgeva, biosimilars that refer to the biotechnologically produced original medicinal product with the trade name Xgeva, and the corresponding import medicinal products. The contract is concluded within the framework of a so-called Open-House model, i.e. a contract conclusion is open to all interested pharmaceutical companies within the participation period, provided they meet and accept the participation requirements. This means that individual contract negotiations are not conducted and there is no (supply) exclusivity. It is pointed out that the quantity to be procured is unknown, as it depends on demand and the development of the number of insured persons, the prescription behaviour of doctors and the dispensing and stocking behaviour of public pharmacies. Accordingly, minimum procurement quantities are not guaranteed. Interested pharmaceutical companies can download the participation documents from the project room of the German Tender Portal (DTVP). To do this, an application for access to the project room is initially required. After the applicant has been granted access by the contracting entity, the participation documents can then be accessed. Absolute confidentiality must be maintained regarding the content of the participation documents - in particular regarding the content of the discount agreement and the discounts mentioned therein. Full or partial disclosure or provision of contents of the participation documents to or for third parties requires the prior written consent of the contracting entity. If participation is waived, all documents must be destroyed immediately in a data protection-compliant manner. The documents to be submitted are set out in the documents "Cover Letter" and "Explanations of the Contract Terms" deposited in the project room. Communication, including the transmission of the participation documents, is carried out electronically via the tender portal DTVP; details can be found in the aforementioned documents. Any contradictory information in the contract notice is due to technical reasons and is not binding. Participation applications can be submitted for the first time by 5 August 2026. All further submission deadlines can be found in the attachment "Submission Deadlines" deposited in the project room. If the deadline for submission falls on a Saturday, Sunday or a public holiday throughout Germany, the next working day shall take its place. In the event of late receipt, the submitted applications will be considered for the next submission deadline. The discount agreement ends, regardless of the date of conclusion of the contract, at the latest on 31 May 2027. The contracting entity reserves the right to terminate the Open-House procedure prematurely, in particular in the event of the conclusion of exclusive discount agreements; in this case, the discount agreements already concluded end in accordance with the contractual provisions. According to the contracting entity's experience, exclusive discount agreements generally come into force 8 to 12 months after the publication of the corresponding contract notice in the Supplement to the Official Journal of the European Union.