WG: Project researches efficient care structures for innovative therapies - Dresden University Hospital is a consortium partner

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Project researches efficient care structures for innovative therapies
Dresden University Hospital is a consortium partner in the “INTEGRATE-ATMP” project, which is funded with 13.6 million euros. Pediatric neurology and hematology are supported in the pre- and follow-up care of gene therapy and CAR T-cell therapies. Dresden teams meet with researchers from the Heidelberg University Hospital for a kick-off meeting. [https://cache.pressmailing.net/thumbnail/ab01132c-0d5c-450c-9ab4-f7e0732754f9/gruppenfoto-KickOff-~EGRATE-ATMP_web.jpg] Group photo for the Dresden kick-off meeting: Teams from the leading Heidelberg University Hospital met on Friday (December 2, 2022) with those involved in the project from the Carl Gustav Carus University Hospital. Photo: Dresden University Hospital / Kirsten Lassig
The aim of the new consortium project “INTEGRATE-ATMP” is to improve the care of patients who use innovative active ingredients in gene and cell therapy. The project, which is being run under the leadership of Heidelberg University Hospital, for which the Carl Gustav Carus University Hospital Dresden was also selected as one of a total of nine university partners, will receive a total of 13.6 million euros over the next four years from the Innovation Fund of the Federal Joint Committee (G-BA ). The focus is on the introduction and development of various tools that can be used to improve the care of patients who receive these novel, innovative therapies (Advanced Therapy Medicinal Products – ATMP). They are used, among other things, for diseases for which there are currently no or only inadequate treatment options. These include certain forms of lymph gland cancer or spinal muscular atrophy (SMA) in children. At the start of the project in Dresden, specialists from the Heidelberg University Hospital will meet with the local teams from the Medical Clinic I and the Neuropediatrics Department of the University Children's Clinic this Friday (December 2nd).
The “INTEGRATE” in the project name stands for integrated care with new therapies through telemedicine, empowerment (knowledge transfer), registers, drug safety, structured therapy paths and reimbursement. This is made possible by the treatment plans that are further structured in the project and coordinated between all centers, with which outpatient pre- and follow-up care, including reimbursement, can be standardized. In addition, a newly set up ATMP registry is intended to record therapy experiences with ATMPs across all diseases and regardless of disease. The plan is to link this documentation with existing disease-specific registries. This solution should also be expandable to new ATMP approvals in the future. Another component of the “INTEGRATE-ATMP” is a telemedical communication platform that will facilitate direct exchange between all those involved in the treatment and institutions and at the same time relieve the burden on patients in their everyday care - also by making the exchange with their practitioners flexible . In addition, the telemedicine platform should work together with the registry and enable structured management of possible undesirable side effects of ATMPs. “This nationwide project shows how it can be possible to overcome two challenges of university medicine in a cross-location project. “Highly complex, innovative therapies and the treatment of rare diseases represent a major financial and personnel burden for individual institutions,” says Prof. Michael Albrecht, Medical Director of the Dresden University Hospital. “The 'INTEGRATE-ATMP' concept not only impresses with its approach of standardizing pre- and aftercare nationwide at an early stage and providing it with corresponding cost reimbursement regulations, but also of creating a telemedicine platform in parallel that can also be used by patients and patients can use. By participating in the project, the Dresden University Hospital can contribute its expertise in the areas of telemedicine, networking and interdisciplinary collaboration as well as its scientific excellence in the fields of oncology and neurodegenerative diseases.”
The term “medicines for advanced therapies” – Advanced Therapy Medicinal Products or ATMP – summarizes a group of innovative active ingredients that consist either of nucleic acids or cell or tissue products. On the one hand, these are gene therapeutics made from nucleic acids. They can be used to replace, repair, remove or regulate either defective or dysfunctional genes. These medications are used, for example, in the treatment of spinal muscular atrophy. The second group of ATMPs is produced from cells or tissues, some of which undergo genetic modifications. In this way, additional functions can be transferred to the cells or tissue. These are, for example, CAR T cells that can be used to attack cancer cells. ATMPs are medicines that are individually tailored to patients and enable more targeted treatment and, in the best case, cure of congenital or acquired diseases.
“INTEGRATE-ATMP” also builds an interdisciplinary bridge at the Dresden University Hospital Prof. Maja von der Hagen, head of the neuropediatrics department at the Clinic for Pediatric and Adolescent Medicine and Dr. Malte von Bonin, senior physician at Medical Clinic I, represents two very different specialist areas that have so far had very few points of contact. This changed in recent years with the advent of ATMPs. The use of these innovative drugs represents a major challenge for treatment teams. This is due, among other things, to the relatively small number of patients - spinal muscular atrophy is a rare disease with an incidence of 1:8,000 to 1:10,000 newborns - as well as the very complex nature of the disease, from the preparation of therapy to aftercare Procedures. To date, the costs of administering these therapeutic agents have only been financed by health insurance companies on a case-by-case basis. The complex pre- and aftercare services could only be billed using the general university outpatient flat rate. As part of “INTEGRATE-ATMP”, a selective contract in accordance with Section 140a of the Fifth Social Security Code is now being negotiated with the Techniker-Krankenkasse as a consortium partner.
Like the Heidelberg University Hospital, the Dresden University Hospital is one of the pioneering institutions in the use of ATMPs. The Medical Clinic I was there from the beginning when CAR T-cell therapy was introduced in Germany and has been certified for this since 2018. It is similar with the field of neuropediatrics. With the availability of gene replacement therapy with “Zolgensma” for spinal muscular atrophy (SMA), children were already treated before approval. The first child in Germany in Heidelberg and the second – “Baby John” – in the Dresden University Hospital. Even though only three to five children affected by SMA are treated with gene replacement therapy at the Dresden University Children's Clinic every year, the human and time effort involved in caring for these girls and boys remains considerable. This is also because the G-BA stipulates follow-up care over 15 years and then the transition and that the treatment is not adequately paid for, with the exception of financing the very expensive medication against the genetic neurological disease. Without gene replacement therapy, children would suffer severe mobility restrictions or die in the first few years of life. “If the 'INTEGRATE-ATMP' project is successful, the current remuneration method can, in the best case scenario, be replaced in the future. Currently, the care provided by university medicine cannot be billed cost-effectively via the university outpatient clinic or the social pediatric centers. We hope that with the 'INTEGRATE-ATMP annual flat rate' we will be able to achieve the necessary transparency and appropriate financing of specialized aftercare so that we can set it up the same for all treatment centers," says Prof. Maja von der Hagen, head of the Department of Neuropediatrics at the Clinic for Pediatric and Adolescent Medicine.
Project creates a scientific basis for aftercare for CAR T-cell therapy The Dresden University Hospital is one of currently two centers in Saxony that offer CAR T-cell therapy. Every year, 30 to 50 patients with malignant diseases of the lymphatic system - lymph gland cancer - who receive CAR T-cell therapy in Medical Clinic I benefit from this. “This form of therapy is very complex and requires regular medical follow-up,” says Dr. Malte von Bonin: “After the actual therapy, our patients suffer from immunodeficiency with an increased tendency to infection and, in some cases, long-term anemia.” To date, there are no nationwide standards for the care of cancer patients after CAR T-cell therapy. The actors here act based on experience. One of the goals of the “INTEGRATE-ATMP” project is therefore to create a scientific basis for these treatment steps. It should be clarified at what interval follow-up examinations take place as standard and which values must be collected. There is also the question of whether and, if so, which medical appointments can be covered by telemedicine. The focus of the project is not only on further improving the medical treatment outcome, but also on the quality of life of those affected.
Along with the Charité, the Dresden University Hospital is the only hospital in the new federal states to be involved in the “INTEGRATE-ATMP” project. Dresden's special expertise in the area of CAR T cells is also reflected in its participation in the future cluster “SaxoCell”, which aims to make living medicines such as CAR T cell therapy available to significantly more patients in the future.
Facts about “INTEGRATE-ATMP”
* Project duration: from October 1, 2022 to September 30, 2026 (four years) * Nine German university hospitals are involved (Charité Berlin, Dresden, Erlangen, Essen, Frankfurt, Hamburg, Heidelberg, University of Munich Hospital, Tübingen). With the exception of the Frankfurt University Hospital, the departments of hemato-oncology and neuropediatrics are involved. * Other consortium partners are the German Register for Stem Cell Transplantation. V., the Institute for Women's Health – Institute Woman's Health GmbH and the Techniker Krankenkasse. * The project is funded with 13.6 million euros from the Innovation Fund of the Federal Joint Committee (G-BA). Of this, 500,000 euros will flow directly to the Dresden location. * The study is not randomized, which means that all participating patients can benefit from the possible advantages of nationwide coordination. * The first patients will be recruited for the project from January.
Contacts for media professionals
Carl Gustav Carus University Hospital Dresden
Department of Neuropediatrics at the Clinic for Child and Adolescent Medicine Head: Prof. Dr. med. Maja von der Hagen Tel. 0351 4 58 37 89 Email: [email protected]<[email protected]> www.uniklinikum-dresden.de/kik<>
Medical Clinic I Dr. med. Malte von Bonin Telephone: 0351 4 58 Email: martin.bornhä[email protected]<mailto:martin.bornh%C3%[email protected]> www.uniklinikuim-dresden.de/mk1

Heidelberg University Hospital
Clinic for Hematology, Oncology and Rheumatology Medical Director: Prof. Dr. med. Carsten Müller-Tidow Tel.: 06221 56-8001 Email Secretariat: [email protected]<[email protected]>
Center for Child and Adolescent Medicine Heidelberg Medical Director: Prof. Dr. med. Georg F. Hoffmann Email: [email protected]<[email protected]> You can log out here<>.