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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?

Author

Listed:
  • Jörg Ruof

    (Roche Pharma AG
    Medical School of Hanover)

  • Thomas Staab

    (Roche Pharma AG)

  • Charalabos-Markos Dintsios

    (Heinrich Heine University)

  • Jakob Schröter

    (Baden-Württemberg Cooperative State University)

  • Friedrich Wilhelm Schwartz

    (Medical School of Hanover)

Abstract

Objectives The aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency (EMA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA). Methods Medicinal products with completed benefit assessments during an assessment period of 3.5 years were considered. PAMs extracted from European Public Assessment Reports (EPARs) were compared with data requests issued by the G-BA in the context of conditional appraisals. Results Twenty conditional appraisals (19 products) and 34 EPARs containing PAMs (33 products) were identified. Data categories (efficacy, safety, etc.), data types (type of study required to address the request) and clarity of requests were determined. Conditional appraisals disproportionately focused on oncology products (13/19 products with conditional appraisals vs. 14/33 products with PAMs). No clear rationale for the G-BA issuing conditional appraisals could be identified in public sources. Both EMA and G-BA requested mainly efficacy and safety data (44/54 and 23/35 categories requested, respectively); however, 28/35 G-BA data requirements went beyond requests made by the EMA. Almost half of the G-BA requests (9/20), but no PAMs, were unclear, and no methodological guidance for fulfilling the data requirements was provided by the G-BA. Conclusions Better alignment between data requests from regulatory authorities and health technology assessment bodies is strongly recommended.

Suggested Citation

  • Jörg Ruof & Thomas Staab & Charalabos-Markos Dintsios & Jakob Schröter & Friedrich Wilhelm Schwartz, 2016. "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 Committ," Health Economics Review, Springer, vol. 6(1), pages 1-11, December.
  • Handle: RePEc:spr:hecrev:v:6:y:2016:i:1:d:10.1186_s13561-016-0124-4
    DOI: 10.1186/s13561-016-0124-4
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    References listed on IDEAS

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    1. 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.
    2. 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.
    3. 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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    Cited by:

    1. 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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