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INDUSTRY'S EXPERIENCES WITH THE SCIENTIFIC ADVICE OFFERED BY THE FEDERAL JOINT COMMITTEE WITHIN THE EARLY BENEFIT ASSESSMENT OF PHARMACEUTICALS IN GERMANY

Published online by Cambridge University Press:  19 February 2018

Charalabos-Markos Dintsios  and
Sara Schlenkrich
Charalabos-Markos Dintsios
Affiliation:
Institute for Health Services Research and Health Economics Heinrich Heine University Dü[email protected]
Sara Schlenkrich
Affiliation:
University of Applied Sciences, Zittau/Görlitz
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Abstract

Objectives: Optional scientific advice (SA) for the early benefit assessment of pharmaceuticals is offered by the German decision maker, the Federal Joint Committee (FJC). The aim of this study was to elicit manufacturers’ experiences with the SA procedures offered by the FJC to date.

Methods: A preliminary survey on a small sample size was conducted. Subsequently, a questionnaire comprising eight items, which was developed on the basis of that survey, was used. Data were analyzed using qualitative and quantitative approaches.

Results: The elicitation, including a sample of 25 percent of the completed advice, highlighted the following, regarding the process as well as to the content shortcomings of the SA procedures from an industrial perspective: inconsistencies, FJC's lack of expertise in conducting clinical trials, partially incomplete answers. and a low willingness of the FJC to engage in dialogue with industry were criticized. On the other hand, the majority of respondents expressed a positive attitude concerning unambiguousness, completeness, traceability, discussion atmosphere, and the protocol of the advice. Early SA, before pivotal trials start, showed a significantly higher completeness compared with late SA with respect to endpoints and study duration. Within 4 years the quality of FJC's propositions on some topics improved significantly.

Conclusions: Only a few statistically significant differences were detectable between early versus late SA. A positive trend in industry's perception of the SA can be observed over time. A more active involvement of additional stakeholders and the incorporation of procedural elements from other healthcare systems could improve the quality of the SA offered by the FJC.

Keywords

Scientific adviceEarly benefit assessmentAMNOGPharmaceutical industryFederal Joint Committee
Type
Policy
Information
International Journal of Technology Assessment in Health Care , Volume 34 , Issue 2 , 2018 , pp. 196 - 204
Copyright
Copyright © Cambridge University Press 2018 

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