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Reimbursement in the Context of Precision Oncology Approaches in Metastatic Breast Cancer: Challenges and Experiences

Pixberg, Constantin ; Schulze, Markus ; Buschhorn, Lars ; Suppelna, Jan Philip ; Mock, Andreas ; Hlevnjak, Mario ; Heublein, Sabine ; Schumacher-Wulf, Eva ; Schneeweiss, Andreas

In: Breast Care, 19 (2024), Nr. 1. pp. 10-17. ISSN 1661-3791(Druck-Ausg.); 1661-3805 (Online-Ausg.)

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Official URL: https://doi.org/10.1159/000533902
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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.

Document type: Article
Journal or Publication Title: Breast Care
Volume: 19
Number: 1
Publisher: Karger
Place of Publication: Basel ; Freiburg, Br. ; Paris ; London ; New York, NY ; Bangalore ; Bangkok ; Shanghai ; Singapore ; Tokyo ; Sydney
Edition: Zweitveröffentlichung
Date Deposited: 15 May 2025 12:49
Date: 2024
ISSN: 1661-3791(Druck-Ausg.); 1661-3805 (Online-Ausg.)
Number of Pages: 8
Page Range: pp. 10-17
Faculties / Institutes: Service facilities > German Cancer Research Center (DKFZ)
Medizinische Fakultät Heidelberg > Universitäts-Frauenklinik
Uncontrolled Keywords: Metastatic breast cancer, Genomics-guided therapies, Reimbursement, Precision oncology, Translational oncology
Additional Information: 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
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