New therapies require innovative healthcare structures

The INTEGRATE-ATMP project aims to develop harmonized and quality-assured tools to ensure the best possible treatment quality for patients receiving ATMPs (Advanced Therapy Medicinal Products). INTEGRATE stands for Integrated Care of New Therapies through Telemedicine, Empowerment, Gene Therapies, Registries, Drug (“Arzneimittel”) Safety, structured Treatment Pathways, and Reimbursement (“Erstattung”).

What are ATMPs?

Advanced therapy medicinal products, or ATMPs, comprise a group of innovative active substances consisting of either nucleic acids or cellular or tissue products. The aim of gene therapy medicinal products composed of nucleic acids is either the replacement, repair, removal or regulation of a defective or dysfunctional gene. The group of so-called somatic cell therapeutics and biotechnologically produced tissue products, on the other hand, consist of cells that are modified in the laboratory in such a way that they acquire additional functions, e.g. in the defence against cancer cells, or replace defective tissue.

In which diseases are ATMPs used?

ATMPs are used, for example, in spinal muscular atrophy (SMA), severe combined immunodeficiencies, adenosine deaminase deficiency (ADA-SCID), metachromatic leukodystrophy (MLD), or as cellular immunotherapy in adult patients (chimeric antigen receptor (CAR) T-cells) for blood and immune cell diseases.

What is the goal of the INTEGRATE-ATMP project?

INTEGRATE-ATMP aims to improve the care of patients receiving ATMPs and provide the best possible care.
The project seeks to establish binding frameworks for the quality-assured and cost-effective use of existing and future ATMPs in Germany, thereby ensuring optimal care for patients. Ideally, this will improve the individual quality of life of ATMP patients. ATMP medical centers are supported implementing, administering and managing outpatient ATMP patient care structures.

Who can participate in the study?

All legally insured (“gesetzlich versicherte”) patients treated at one of the participating medical centers for their ATMP therapy can take part in the project.

Consortium

Under the leadership of Heidelberg University Hospital, 23 additional medical centers, the Techniker Krankenkasse (health insurance), national registry operators, the Institute of Management/Chair of Health Management at Friedrich-Alexander University Erlangen-Nürnberg, and the Institute Women’s Health in Tübingen have joined forces within a consortium for the INTEGRATE-ATMP project.

Scientific Advisory Board

The consortium develops and coordinates the project components (= structural measures) within the project with the Scientific Advisory Board established for this purpose. This board is composed of experts from professional associations, representatives of patient organizations, representatives of physicians’ associations, and other partners.