Highlights
- What is already known about the topic?
- The benefit assessment of tumor-agnostic therapies leaves stakeholders with various challenges.
- What does the paper add to existing knowledge?
- The paper systemized these challenges and identified possible solutions for the benefit assessment of tumor-agnostic therapies in Germany. Categories of challenges included ‘Determination of the appropriate comparator’, ‘No comparative studies’ and ‘Basket studies’. Solutions proposed in the literature are manifold and include, e. g., the increased use of real-world evidence.
- What insights does the paper provide for informing health care-related decision making?
- We identified a range of possible solutions, which could guide future reforms, in Germany and beyond, towards more value in health. Future research should investigate the acceptance and feasibility of these solutions.
Abstract
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In Press Accepted ManuscriptFootnotes
Précis: Challenges of the German benefit assessment process regarding tumor-agnostic indications are manifold. This study’s aim was to systematize these challenges and identify possible solutions.
Author Contributions:
Concept and design: Schiller, Eckhardt, Schmitter, Rombey
Acquisition of data: Schiller, Alber
Analysis and interpretation of data: Schiller, Eckhardt, Alber, Rombey
Drafting of the manuscript: Schiller, Rombey
Critical revision of paper for important intellectual content: Schiller, Eckhardt, Schmitter, Alber, Rombey
Statistical analysis: Schiller
Administrative, technical, or logistic support: Schmitter
Supervision: Rombey
Conflict of Interest Disclosures: Ms Schiller was employed by Pfizer during the conduct of this research. This research was conducted as part of her master’s thesis. She reported receiving salary from Pfizer Pharma GmbH. Ms Schmitter reported receiving stock and stock options from Pfizer Inc. She is an employee and shareholder of Pfizer. No other disclosures were reported.
Funding/support: There was no grant funding for this project. JS received salary support by Pfizer Pharma GmbH. The open access publication fee was paid by the Department of Health Care Management, Technische Universität Berlin.
Role of Funder/Sponsor:
There was no formal funder or sponsor.
Acknowledgements: The authors wish to thank all experts who participated in the interviews.
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