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Early Benefit Assessment of Pharmaceuticals in Germany

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  • Katharina E. Fischer
  • Tom Stargardt

Abstract

Background. Since 2011, when the German Pharmaceutical Market Restructuring Act (AMNOG) came into effect, newly licensed pharmaceuticals must demonstrate an added benefit over a comparator treatment to be reimbursed at a value greater than the reference price. Evidence submitted by manufacturers is assessed by the Institute for Quality and Efficiency in Health Care (IQWiG) and subsequently appraised by the German Federal Joint Committee (FJC) as part of so-called early benefit assessments (EBA). This study aims to explain the decisions made, clarify the roles of the parties (manufacturers, IQWiG, FJC) involved, and guide manufacturers in developing future submissions by analyzing 42 EBAs concluded since January 2011. Methods. We developed a variable list representing the essential components of the EBA: the rating decisions of manufacturers, IQWiG, and the FJC regarding each pharmaceutical’s added benefit; the characteristics of the pharmaceutical; the characteristics of the EBA process; the types of evidence submitted; the methods used to generate evidence; and the pharmaceutical’s maximum possible budget impact. We used Cohen’s kappa to analyze agreement between the rating decisions of the different parties. The chi-square test and bivariate regression were used to identify associations between components of the EBA process and the rating decisions of the FJC. Results. We observed a low level of agreement between manufacturers and the FJC (kappa = 0.21; 95% CI 0.107–0.31) and a substantial level of agreement between IQWiG and the FJC (kappa = 0.64; 95% CI 0.451–0.827) in their rating decisions. The characteristics of the EBA process—for example, duration of the process ( P = 0.357), participation in the official hearing ( P = 0.227), and the pharmaceutical’s budget impact ( P = 0.725)—did not have a significant effect on the rating decisions of the FJC. There was, however, an association between the type of evidence submitted and the FJC’s rating decision when the manufacturer’s dossier reported outcomes related to morbidity ( P = 0.009) or adverse events ( P

Suggested Citation

  • Katharina E. Fischer & Tom Stargardt, 2014. "Early Benefit Assessment of Pharmaceuticals in Germany," Medical Decision Making, , vol. 34(8), pages 1030-1047, November.
    • Handle: RePEc:sae:medema:v:34:y:2014:i:8:p:1030-1047
    DOI: 10.1177/0272989X14546377
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    References listed on IDEAS

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    1. Henschke, Cornelia & Sundmacher, Leonie & Busse, Reinhard, 2013. "Structural changes in the German pharmaceutical market: Price setting mechanisms based on the early benefit evaluation," Health Policy, Elsevier, vol. 109(3), pages 263-269.
    2. Mitton, Craig R. & McMahon, Meghan & Morgan, Steve & Gibson, Jennifer, 2006. "Centralized drug review processes: Are they fair?," Social Science & Medicine, Elsevier, vol. 63(1), pages 200-211, July.
    3. Lesley Chim & Patrick Kelly & Glenn Salkeld & Martin Stockler, 2010. "Are Cancer Drugs Less Likely to be Recommended for Listing by the Pharmaceutical Benefits Advisory Committee in Australia?," PharmacoEconomics, Springer, vol. 28(6), pages 463-475, June.
    4. Fischer, Katharina Elisabeth, 2012. "A systematic review of coverage decision-making on health technologies—Evidence from the real world," Health Policy, Elsevier, vol. 107(2), pages 218-230.
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    Cited by:

    1. Giulini-Limbach, Chiara & Bauer, Cosima & May, Uwe, 2021. "Arzneimittelmarkt-Steuerung unter dem Einfluss von AMNOG und Festbeträgen: Forschungsprojekt im Auftrag der Bristol-Myers Squibb GmbH & Co. KGaA," IBES Diskussionsbeiträge 232, University of Duisburg-Essen, Institute of Business and Economic Studie (IBES).
    2. Böhler, Yvonne-Beatrice & Lamping, Christian & Wichardt, Philipp C., 2019. "Pharmaceutical prices: The impact of the launch strategy. An analysis of German data," Kiel Working Papers 2141, Kiel Institute for the World Economy (IfW Kiel).
    3. Yvonne-Beatrice Böhler & Christian Lamping & Philipp Christoph Wichard & Philipp Christoph Wichardt, 2019. "Pharmaceutical Prices: The Impact of the Launch Strategy - An Analysis of German Data," CESifo Working Paper Series 7879, CESifo.
    4. Katharina Elisabeth Blankart & Tom Stargardt, 2020. "The impact of drug quality ratings from health technology assessments on the adoption of new drugs by physicians in Germany," Health Economics, John Wiley & Sons, Ltd., vol. 29(S1), pages 63-82, October.

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