REVIEW OF DATA CUTS USED AS BASIS FOR STATISTICAL ANALYSES AND DERIVATION OF ADDITIONAL BENEFIT PRESENTED WITHIN GERMAN BENEFIT ASSESSMENTS FOR ONCOLOGICAL DRUGS

Author(s)

Kuehnast S, Kuerschner N, Leverkus F
Pfizer Deutschland GmbH, Berlin, Germany

OBJECTIVES: Since the Act on the Reform of the Market for Medicinal Products (AMNOG) became effective in Germany in 2011, pharmaceutical manufacturers must submit a benefit dossier demonstrating an additional benefit of a new drug compared to an appropriate comparative therapy. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) decides conclusively on the extent of the additional benefit. The assessment is based on the presented clinical study data in the benefit dossier considering its specific methodological requirements. Especially in oncological trials, further data cuts are often prespecified in the study protocol in addition to the data cut for the final analysis of the primary endpoint.The aim of this study is to investigate benefit assessments regarding the presented data cuts and their consideration for the derivation of additional benefit and to examine whether a gold standard can be derived. METHODS: Recently published benefit assessments of oncological drugs are screened with regard to the data cuts presented. It is summarized on how much and which data cuts statistical analyses have been presented, including possible variations regarding presentation of subgroup analyses. Eventually, an evaluation of the existence of a gold standard is conducted.  RESULTS: Based on the included benefit assessments no clear gold standard can be derived. The number and rationale of data cuts presented often varied. Statistical analyses, including subgroup analyses, were often presented based on the clinical study report data cut. Analyses of overall survival and adverse events were often presented on additional later data cuts, not necessarily including subgroup analyses. CONCLUSIONS: A lack of precisely defined requirements make it necessary to decide individually on the basis of which data cuts statistical analyses should be presented within the benefit dossier.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PCN296

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Oncology

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