VP107 Pharmaceutical Industry's Experiences with the German Health Technology Assessment Scientific Advice

Abstract

INTRODUCTION:

The early benefit assessment of drugs was introduced in Germany with the ‘Act to Reorganize the Pharmaceuticals’ Market in the SHI’ (AMNOG) in 2011. Before submitting the manufacturer's dossier, optional scientific advice is offered by the Federal Joint Committee (G-BA). The objective was to elicit manufacturers experience with the scientific advice offered by the Federal Joint Committee.

METHODS:

To prepare the survey, several manufacturers were interviewed on their experience with the scientific advice offered by the Federal Joint Committee. Subsequently, a questionnaire was developed to collect information for this purpose, comprising eight items on different topics aimed at understanding the perceived quality of the scientific advice provided.

RESULTS:

The qualitative part comprised seven manufacturers who had received between one and ten advisories before the end of 2012. With regard to the quantitative elicitation part, a total of sixty-one completed questionnaires from nineteen manufacturers were included until the beginning of 2015 (corresponding to almost 25 percent of the overall implemented scientific advice). Fourteen cases were about so called “early” scientific advice in terms of relating to evidence before commencing phase-III trials, forty-four cases concerned “late” scientific advice (pivotal trials were just conducted or already terminated), another two concerned repeated scientific advice and finally, four referred to miscellaneous contents (multiple answers possible). Both, the preceding qualitative and the following quantitative part of the elicitation, highlighted points about the process as well as the content shortcomings from an 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. Over 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 are systems with longer experience could improve the scientific advice provided.