BRIDGING HTA AGENCIES ACROSS EUROPE- A SYSTEMATIC APPROACH TO CATEGORIZE EVOLVING AGENCIES

Author(s)

Nagy L1;Kamal-Bahl S*2, Brandtmüller A3 1MSD Pharma Hungary Ltd., Budapest, Hungary, 2Merck & Co., Inc., Sumneytown Pike, PA, USA, 3MSD Pharma Hungary, Budapest, Hungary

OBJECTIVES: HTA agencies are mushrooming in Europe. Industry faces the challenge to meet their diverse requirements and comply with decision criteria. Our aim was to investigate similarities and distinguishing characteristics of HTA agencies, to identify the anchor institutes that use different approaches to HTA and serve as a reference for others, and to assign other countries to one of the anchor institutes. METHODS: We identified the primary institutions in European countries where HTA plays a role in decision making. We developed a template for the unified assessment of the input needs of the agencies, and a set of criteria an anchor country should meet.. Agencies were assessed based on a literature review, and assigned to one of the anchor countries, which was validated by MSD subsidiaries across Europe. Future trends in anchor countries were investigated. RESULTS: We identified three anchor institutes in Europe using different value assessment concepts. IQWIG in Germany primarily assesses HTA submissions on the basis of patient related outcomes requiring hard endpoints. HAS in France sees the medical benefit of technologies in innovativeness rating them from no innovation to breakthrough innovation. NICE in England asks for evidence of cost-effectiveness as one of its major considerations. We found that other European countries tend to primarily follow one of these concepts. Analysing future trends, one can see converges in the fields of HTA requirements, between regulatory and HTA, in coordination and process harmonization, and regional and international collaboration. CONCLUSIONS: European HTA agencies can be systemized based on their requirements. This review can serve as a depository of individual country needs in HTA, an input to the design of clinical trials, and can support the development of industrial HTA strategies. Such a snapshot however cannot substitute the deep knowledge of local requirements and needs regular update to follow-up future trends.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PHP141

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling

Disease

Multiple Diseases

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