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Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation

Author

Listed:
  • Jörg Ruof
  • Friedrich Schwartz
  • J.-Matthias Schulenburg
  • Charalabos-Markos Dintsios

Abstract

Considerable variance was observed in the levels of additional benefit reported by pharmaceutical manufacturers, IQWiG and G-BA. The areas of disagreement included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events. Copyright The Author(s) 2014

Suggested Citation

  • 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.
    • Handle: RePEc:spr:eujhec:v:15:y:2014:i:6:p:577-589
    DOI: 10.1007/s10198-013-0495-y
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    Citations

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    Cited by:

    1. Niehaus, Ines & Dintsios, Charalabos-Markos, 2018. "Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs," Health Policy, Elsevier, vol. 122(6), pages 599-606.
    2. Christine Blome & Matthias Augustin & Hidayet Metin & David Lohrberg, 2017. "Four years of early benefit assessment of new drugs in Germany: a qualitative study on methodological requirements for quality of life data," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 18(2), pages 181-193, March.
    3. Chassagnol, F & Marcelli, G & Wagle, J & Giuliani, G & Traub, D & Schaub, V & Ruof, J, 2020. "Review of Relative effectiveness assessments (REAs) of pharmaceuticals at the European network for health technology assessment (EUnetHTA): A first step towards a consolidated European perspective on ," Health Policy, Elsevier, vol. 124(9), pages 943-951.
    4. 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.
    5. 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.
    6. Omer Ben-Aharon & Oren Shavit & Racheli Magnezi, 2017. "Does drug price-regulation affect healthcare expenditures?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 18(7), pages 859-867, September.
    7. 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.
    8. Stephan Eger & Jörg Mahlich, 2014. "Pharmaceutical regulation in Europe and its impact on corporate R&D," Health Economics Review, Springer, vol. 4(1), pages 1-9, December.
    9. Hostenkamp, Gisela & Fischer, Katharina Elisabeth & Borch-Johnsen, Knut, 2016. "Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark," Health Policy, Elsevier, vol. 120(12), pages 1404-1411.

    More about this item

    Keywords

    Health care reform; (Early) benefit assessment; Appropriate comparative therapy; Market access; AMNOG; I10; I11; I18;
    All these keywords.

    JEL classification:

    • I10 - Health, Education, and Welfare - - Health - - - General
    • I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets
    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health

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