Germany – Pharmaceutical products – Abschluss nicht exkl. Arzneimittel-Rabattvereinb. nach § 130a Abs. 8 SGB V im Wege eines Open-House-Modells zum Wirkstoff Omalizumab (ATC-Code nach WHO: R03DX05)

The subject of this publication is the conclusion of non-exclusive discount agreements pursuant to Section 130a, Paragraph 8, SGB V on medicinal products with the active substance Omalizumab (ATC Code according to WHO: R03DX05). The contract conclusion takes place 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 that they meet and accept the participation requirements. This results in individual contract negotiations not being conducted and no (supply) exclusivity being given. It is pointed out that the quantity to be procured is unknown, as this depends on demand and the development of the number of insured persons, the prescribing 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 via the project room of the German Tender Portal (DTVP). To do this, an application for access to the project room is first required. After activation 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. Any full or partial disclosure or provision of content 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" filed in the project room. Communication, including the transmission of the participation documents, takes place electronically via the tender portal DTVP; details can be found in the aforementioned documents. Any contrary statements in the contract notice are due to technical reasons and do not claim any binding effect. Participation applications can be submitted for the first time by 3 September 2026. All further submission deadlines can be found in the annex "Submission Deadlines" filed in the project room. If the deadline for submission falls on a Saturday, Sunday or a public holiday nationwide, the next working day will take its place. In the event of late receipt, the submitted participation applications will be considered for the next submission deadline. The discount agreement ends, irrespective of the date of conclusion of the contract, by 30 September 2027 at the latest. 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 will end in accordance with the contractual provisions. According to the experience of the contracting entity, 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.