eprintid: 36567
rev_number: 11
eprint_status: archive
userid: 5878
dir: disk0/00/03/65/67
datestamp: 2025-05-15 12:49:38
lastmod: 2025-05-26 17:50:42
status_changed: 2025-05-15 12:49:38
type: article
metadata_visibility: show
creators_name: Pixberg, Constantin
creators_name: Schulze, Markus
creators_name: Buschhorn, Lars
creators_name: Suppelna, Jan Philip
creators_name: Mock, Andreas
creators_name: Hlevnjak, Mario
creators_name: Heublein, Sabine
creators_name: Schumacher-Wulf, Eva
creators_name: Schneeweiss, Andreas
title: Reimbursement in the Context of Precision Oncology Approaches in Metastatic Breast Cancer: Challenges and Experiences
ispublished: pub
divisions: i-850300
divisions: i-910400
keywords: Metastatic breast cancer, Genomics-guided therapies, Reimbursement, Precision oncology, Translational oncology
note: 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
abstract: 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.
date: 2024
date_type: published
publisher: Karger
id_scheme: DOI
id_number: 10.11588/heidok.00036567
official_url: https://doi.org/10.1159/000533902
ppn_swb: 1926647920
own_urn: urn:nbn:de:bsz:16-heidok-365677
language: eng
bibsort: PIXBERGCONREIMBURSEM2024
full_text_status: public
publication: Breast Care
volume: 19
number: 1
place_of_pub: Basel ; Freiburg, Br. ; Paris ; London ; New York, NY ; Bangalore ; Bangkok ; Shanghai ; Singapore ; Tokyo ; Sydney
pagerange: 10-17
pages: 8
issn: 1661-3791(Druck-Ausg.); 1661-3805 (Online-Ausg.)
edition: Zweitveröffentlichung
citation:   Pixberg, Constantin ; Schulze, Markus ; Buschhorn, Lars ; Suppelna, Jan Philip ; Mock, Andreas ; Hlevnjak, Mario ; Heublein, Sabine ; Schumacher-Wulf, Eva ; Schneeweiss, Andreas  (2024) Reimbursement in the Context of Precision Oncology Approaches in Metastatic Breast Cancer: Challenges and Experiences.  Breast Care, 19 (1).  pp. 10-17.  ISSN 1661-3791(Druck-Ausg.); 1661-3805 (Online-Ausg.)     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/36567/1/BRC533902.pdf