PHARMACEUTICAL INDUSTRY'S EXPERIENCES WITH THE SCIENTIFIC ADVICE OFFERED BY THE FEDERAL JOINT COMMITTEE WITHIN THE EARLY BENEFIT ASSESSMENT OF DRUGS IN GERMANY
Author(s)
Dintsios C1, Schlenkrich S2
1Heinrich Heine University of Düsseldorf, Düsseldorf, Germany, 2University of Applied Science Zittau/Görlitz, Görlitz, Germany
OBJECTIVES: The early benefit assessment of drugs was introduced in Germany in 2011. The objective was to elicit pharmaceutical manufacturers’ experiences with the scientific advices offered by the Federal Joint Committee so far. METHODS: Several pharmaceutical manufacturers were interviewed on their experiences with the scientific advices offered by the federal Joint committee. Subsequently, a specifically for this purpose developed questionnaire comprising eight items on different topics and the perceived quality of the scientific advice was utilized. RESULTS: The qualitative part comprised 7 manufacturers with 1 to 10 advices till end of 2012. With regard to the quantitative elicitation part a total of 61 completed questionnaires from 19 manufacturers were included till the beginning of 2015 (corresponding to 25% of the advices). 14 cases were about “early” advices in terms of relating to evidence before commencing phase-III trials, 44 cases concerned “late” advices (pivotal trials were just conducted or already terminated), another 2 repeated scientific advices and finally, 4 referred to miscellaneous contents (multiple answers possible). Both, the preceding qualitative and the following quantitative part of the elicitation, highlighted with regard to the process as well as to the content shortcomings from a pharmaceutical industry’s point of view: Inconsistencies, lacking expertise with conducting clinical trials, partially incomplete answers and a low readiness to engage in dialogue were criticized. On the other hand, the majority of respondents showed a positive attitude concerning unambiguousness, completeness, traceability, atmosphere and the protocol of the advice. In the course of time, propositions on study design, agreement with the determined appropriate comparative therapy and subgroup definitions improved significantly. CONCLUSIONS: A more active involvement of further stakeholders and the incorporation of procedural elements from other health care systems with longer experience, shared by the international research-based pharmaceutical industry at least, could improve the scientific advices offered by the decision maker in Germany.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP60
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Multiple Diseases