TY  - JOUR
JF  - Breast Care
PB  - Karger
SN  - 1661-3791(Druck-Ausg.); 1661-3805 (Online-Ausg.)
N1  - Dieser Beitrag ist aufgrund einer (DFG-geförderten) Allianz bzw. Nationallizenz frei zugänglich. *** This publication is freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively
Y1  - 2024///
N2  - Background:Precision oncology programs using next-generation sequencing to detect predictive biomarkers are extending therapeutic options for patients with metastatic breast cancer (mBC). Regularly, based on the recommendations of the interdisciplinary molecular tumor board (iMTB), an inclusion in a clinical trial is not possible. In this case, the German health insurance system allows for the application of reimbursement for an off-label drug use. Here, we describe the current challenges and our experience with reimbursement of molecular therapies in mBC. Methods:A total of 100 applications for reimbursement of off-label therapies recommended by an iMTB were filed for patients with mBC, of which 89 were evaluable for this analysis. The approval rate was correlated with the molecular level of evidence of the respective therapy according to the National Center for Tumor Diseases (NCT) and European Society for Medical Oncology Scale for Clinical Actionability of molecular Targets (ESCAT) classification as well as with pretreatment therapy lines. <b><i>Findings:</i></b> Overall, 53.9% (48/89) of reimbursement applications were approved. Applications for therapies based on level of evidence m1 (NCT classification), tier I and II (ESCAT classification) had a significantly and clinically relevant increased chance of reimbursement, while a greater number of previous treatment lines had no significantly increased chance of approval, though a trend of approval toward higher treatment lines was detectable. <b><i>Interpretation:</i></b> Currently, the German jurisdiction seems to aggravate the clinical implementation of clinically urgently needed molecular therapies.
VL  - 19
IS  - 1
EP  - 17
AV  - public
SP  - 10
TI  - Reimbursement in the Context of Precision Oncology Approaches in Metastatic Breast Cancer: Challenges and Experiences
A1  - Pixberg, Constantin
A1  - Schulze, Markus
A1  - Buschhorn, Lars
A1  - Suppelna, Jan Philip
A1  - Mock, Andreas
A1  - Hlevnjak, Mario
A1  - Heublein, Sabine
A1  - Schumacher-Wulf, Eva
A1  - Schneeweiss, Andreas
UR  - https://doi.org/10.1159/000533902
KW  - Metastatic breast cancer
KW  -  Genomics-guided therapies
KW  -  Reimbursement
KW  -  Precision oncology
KW  -  Translational oncology
CY  - Basel ; Freiburg, Br. ; Paris ; London ; New York, NY ; Bangalore ; Bangkok ; Shanghai ; Singapore ; Tokyo ; Sydney
ID  - heidok36567
ER  -