Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs
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DOI: 10.1016/j.healthpol.2018.03.017
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- Inna Dabisch & Jürgen Dethling & Charalabos-Markos Dintsios & Melanie Drechsler & Daniel Kalanovic & Peter Kaskel & Frank Langer & Jörg Ruof & Thorsten Ruppert & Daniel Wirth, 2014. "Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany," Health Economics Review, Springer, vol. 4(1), pages 1-8, December.
- Jörg Ruof & Friedrich Schwartz & J.-Matthias Schulenburg & Charalabos-Markos Dintsios, 2014. "Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(6), pages 577-589, July.
- Fischer, Katharina Elisabeth & Heisser, Thomas & Stargardt, Tom, 2016. "Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia," Health Policy, Elsevier, vol. 120(10), pages 1115-1122.
- Ruof, Jörg & Knoerzer, Dietrich & Dünne, Anja-Alexandra & Dintsios, Charalabos-Markos & Staab, Thomas & Schwartz, Friedrich Wilhelm, 2014. "Analysis of endpoints used in marketing authorisations versus value assessments of oncology medicines in Germany," Health Policy, Elsevier, vol. 118(2), pages 242-254.
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- Matthias Herpers & Charalabos-Markos Dintsios, 2019. "Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 20(1), pages 45-57, February.
- C. M. Dintsios & F. Worm & J. Ruof & M. Herpers, 2019. "Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree," Health Economics Review, Springer, vol. 9(1), pages 1-15, December.
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Keywords
Early benefit assessment; Market authorization; Confirmatory endpoints; Explorative endpoints; Benefit-risk ratio; Benefit-harm balance;All these keywords.
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