Background

INTEGRATE-ATMP is a research project funded by the Innovation Fund of the statutory health insurance system with the aim of optimising the supply of advanced therapy medicinal products (ATMPs) in Germany.
For this project, 24 specialised German treatment centres with many years of experience in the treatment of children and adults with ATMPs have joined forces under the leadership of the Clinic for Haematology, Oncology and Rheumatology (Internal Medicine V, Heidelberg University Hospital, UKHD) and Clinic I (General Paediatrics, Neuropaediatrics, Metabolism, Gastroenterology and Nephrology, Centre for Paediatric and Adolescent Medicine, UKHD). ATMPs are active substances for use in humans that are based on genes, tissues or cells. They offer innovative possibilities for the treatment of congenital diseases of childhood and adolescence and acquired diseases, e.g. tumours of the haematopoietic system. They are used as gene therapeutics for diseases for which there were previously no or only inadequate treatment options.
Patients with the following indications and already approved and used ATMPs are included in the project:

• Gene therapy for the treatment of spinal muscular atrophy (SMA), a severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) and metachromatic leukodystrophy (MLD)
• CAR T-cell therapy with gene-therapeutically modified endogenous immune cells for the treatment of malignant diseases of the lymphatic system (B-cell lymphomas)

The project has been funded by the Innovation Committee of the Joint Federal Committee (G-BA) and the statutory health insurance funds (INTERGRATE-ATMP) for four years since 2022 with a total of around 13.6 million euros
Other partners include the operators of existing national registries, the Techniker Krankenkasse health insurance company on the payer side, patient representatives, registered doctors, specialist associations and federal authorities.

Vision

INTEGRATE-ATMP aims to make a significant contribution to creating a forward-looking, efficient and binding framework for the quality-assured use of existing and future ATMPs in Germany, thereby ensuring the best possible care for patients. The structural measures include

• the introduction of structured treatment plans for outpatient pre- and aftercare,
• the establishment of a cross-disease ATMP register that can be expanded for future ATMP authorisations,
• the introduction of a telemedical communication and exchange platform for patients and practitioners, including those in private practice and referring physicians,
• structured management of potential adverse drug reactions and the establishment of a comprehensive therapy decision board with the participation of paediatricians in private practice (for the indication SMA).

Contact

Dr Andreas Ziegler, M.sc.

TO THE HOMEPAGE of INTEGRATE-ATMP and explanatory video

INTEGRATE ATMP (integrate-atmp.de)