Questioning Conclusions and Statements on the German HTA System: A Critical Perspective

Author:

Tomeczkowski Jörg1,Heidbrede Tanja2ORCID,Leverkus Friedhelm3,Schmitter Sarah3,Dintsios Charalabos‐Markos4,Osowski Ulrike5,Herrmann Kirsten H.6,Bluhmki Tobias7,Marx Almuth8,Eichinger Birte8,Basic Edin9,Bussilliat Paul10,Dietrich Eva Susanne1ORCID

Affiliation:

1. Institute for Evidence‐Based Positioning in the Health Care Sector at the University of Bonn Bonn Germany

2. UCB BioSciences Monheim Germany

3. Pfizer Pharma Berlin Germany

4. Institute for Health Services Research and Health Economics, Medical Faculty Heinrich Heine University Düsseldorf Düsseldorf Germany

5. Merck Healthcare Germany Darmstadt Germany

6. Pharming Ottobrunn Germany

7. Bristol‐Myers Squibb Munich Germany

8. Novartis AG Nuremberg Germany

9. Berlin School of Economics and Law Berlin Germany

10. vfa Berlin Berlin Germany

Publisher

Wiley

Reference5 articles.

1. Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions

2. G‐BA decision report Alectinib (2017). Accessed February 6 2024.

3. IQWIG Assessment Report Alectinib (2017). Accessed February 6 2024.

4. IQWIG Assessment Report Asfostase Alfa (2020). Accessed February 6 2024.

5. Example for G‐BA position on Progression‐free Survival inJustification of the Resolution of the Federal Joint Committee (G‐BA) on an Amendment of the Pharmaceuticals Directive: Annex XII – Benefit Assessment of Medicinal Products with New Active Ingredients according to Section 35a SGB V Abemaciclib (reassessment after the deadline: breast carcinoma HR+ HER2‐ combination with fulvestrant). Accessed September 24 2023.

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