The Centers for Personalized Medicine (Zentren für Personalisierte Medizin, ZPM) have been established at the four university hospitals in the federal state of Baden-Wuerttemberg (approx. 11 Mio inhabitants), located in Southwest Germany, with the goal to make the developments of personalised medicine accessible to all affected patients in that region. Starting from implementing precision oncology into patient care for patients with tumour diseases at an advanced stage, current activities aim to expand the ZPM concept to immune-mediated diseases, e.g. psoriasis, inflammatory bowel disease and rheumatoid arthritis. Patients will benefit from quality-assured harmonized comprehensive molecular diagnostic and tailored therapy recommendations provided by the interdisciplinary molecular boards.
Molecular tumour boards mainly address cases of cancer patients where no clear standard treatment is available – either because the standard treatment was not successful or because there is no “standard” – for example in rare cancer forms or unusual progression of disease. As the cases presented are very complex, a highly interdisciplinary team is needed. Based on comprehensive molecular profiling of tumour tissue, the board develops personalised treatment recommendations that are often successful where conventional therapies fail. In a similar way, molecular inflammation boards are being established that try to find new solutions for patients with immune-mediated diseases.
The therapy itself is carried out either at the ZPMs or decentralized by the local cooperation partners. In comparison to conventional standard treatment, where patients with the same disease are offered a similar therapy according to established guidelines, personalised medicine offers individually tailored treatment options aiming to improve the outcome while reducing undesirable side effects for the patient.
In order to harmonize and further develop molecular diagnostics, structures and processes concerning molecular tumour boards, and data formats and IT-standards the ZPMs have implemented six permanent interdisciplinary working groups: MTB Harmonization and Consulting, Diagnostics, Medical Informatics, Bioinformatics, Medical Imaging, and Clinical Trials.
Integration of Personalised Medicine into the clinical healthcare system
From 2017 on, the Ministry of Social Affairs and Integration of Baden-Wuerttemberg supported the implementation of personalised medicine into an affordable, accessible and fair healthcare system resulting in the foundation of four ZPMs as specialized academic centers for personalised oncology, with the intention to expand it to further disease areas. The aims of the ZPMs are to offer similar provision of precision medicine at all four ZPM sites, a comprehensive local roll-out concept including transparent information of patients and physicians, and setting the fundaments for data sharing between the centers. In the initiative all relevant stakeholders are involved, such as ministries (Social Affairs, Health, Science), health insurance companies, all ZPM sites (representatives of university hospital administration, clinics, diagnostics), patient advocacy groups, other network partners, such as the German Cancer Research Center (DKFZ), non-academic hospitals, medical service of the health insurances (MDK) and industry. Recently, the regional government, the university hospitals and the health insurance funding bodies together successfully agreed on a comprehensive sustainable financing model by which the four centers are supported and innovative diagnostic and treatment costs are covered mainly by the healthcare insurances. In addition, a consented, rapid and standardized validation process for reimbursement of recommended treatments beyond guideline recommendations was established. Thus, the ZPM initiative is an example for a successful and comprehensive implementation of personalised medicine into routine healthcare.
All ZPMs have an identical basic structure comprising a board of directors, administration personnel and six fully functional core areas (molecular diagnostics, radiology, therapy, data management, biobanking, training/education). Each ZPM is represented by a spokesperson who together comprise the ZPM steering board. At the regional (state) level the advisory board, comprising all stakeholders, monitors the overall activities of the ZPMs.
bwHealthCloud - Data structure in the ZPM network
One focus in the establishment of the ZPMs is the non-commercial central data sharing bwHealthCloud platform which allows monitoring of pseudonymized outcome data, informing interdisciplinary molecular tumour boards for therapy recommendations as well as clinical trials, and provides data for basic and translational research projects to further improve healthcare within the concept of personalised medicine. Currently, the platform is successfully implemented and the go-live is planned for early 2022.
Last year, national organizations (Federal Joint Committee and German Cancer Aid) have decided to adopt the ZPM-concept nationwide, and the national roll-out to all 14 German Comprehensive Cancer Centers has started in August 2021. Based on the success of the ZPMs in Baden-Wuerttemberg the aim is to implement personalised medicine with the focus on oncology at the national level.