THIRD PARTY PARTICIPATION IN EARLY BENEFIT ASSESSMENT OF CANCER DRUGS IN GERMANY

Author(s)

Schmidt U
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

OBJECTIVES: In Germany third parties like manufacturers, physician associations, medical societies, or industry organisations are allowed to comment on the early benefit assessments (EBA) of drugs by submitting written statements (WS) and attending oral hearings (OH) before the Federal Joint Committee (G-BA) decides on a resolution. This review assesses the number of WS and OH participants of cancer drugs’ EBA and evaluates trends in third party participation (TPP). METHODS: The status of cancer drugs’ EBA and associated documents from 2011 until May 2014 were retrived from the G-BA website. All completed assessments were included if a summary documentation including the OH protocoll and all WS was available. Information on number and category of third parties submitting WS or attending OH were extracted from the summary documentation, categorized and analysed. RESULTS: Until May 2014 28 cancer drugs’ EBA were started and 25 completed. Summary documentation was available for 14 (56%) completed assessments. The mean number of submitted WS was 9.1 (range 4-16). The mean number of third parties in OH was 5.9 (range 3-9). In all EBA the manufacturer submitted WS and participated in the OH. Representatives of at least one competitor and pharmaceutical industry organizations each were present in all OH. Apart from one EBA, for which no dossier was available, medical societies always turned in WS and attended 11 (85%) OH. In the beginning of the EBA process the number of submitted WS was slightly higher. Overall, no trend for TPP in OH was identified. CONCLUSIONS: In Germany TPP in cancer drugs’ EBA is broadly used by both medical societies and the pharmaceutical industry. Further research is required to identify reasons why medical societies do not attend OH although a WS was handed in.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PCN271

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Oncology

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