Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?
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DOI: 10.1186/s13561-016-0124-4
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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.
- Andrea Lebioda & David Gasche & Franz-Werner Dippel & Karlheinz Theobald & Stefan Plantör, 2014. "Relevance of indirect comparisons in the German early benefit assessment and in comparison to HTA processes in England, France and Scotland," Health Economics Review, Springer, vol. 4(1), pages 1-14, December.
- 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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- Franziska Worm & Charalabos-Markos Dintsios, 2020. "Determinants of Orphan Drug Prices in Germany," PharmacoEconomics, Springer, vol. 38(4), pages 397-411, April.
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Keywords
Marketing authorisation; Post-authorisation measure; (Early) benefit assessment; Conditional appraisal; EMA; G-BA;All these keywords.
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