GOOD COP, BAD COP; G-BA AND IQWIG IN CLINICAL OUTCOME EVALUATIONS

Author(s)

Pontynen A, Jaksa A
Context Matters, New York, NY, USA

OBJECTIVES:  G-BA and IQWiG state the same guidelines for assessing clinical efficacy data on Mortality, Morbidity, and Quality of Life (QoL). This analysis compares the two agencies’ approaches to clinical data evaluation to determine if they interpret the guidelines and standards similarly in practice, and accept the same outcomes for demonstrating benefit. METHODS: This analysis included 98 G-BA and 153 IQWiG evaluations for 88 different drugs across 41 disease conditions. 1,312 clinical outcomes were evaluated to determine the rates of outcome rejection. Rejection was defined as instances where the manufacturer submitted information and G-BA or IQWiG concluded that the data was not usable; instances of no data or inconclusive data were excluded. RESULTS:

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

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

Code

PHP169

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

Multiple Diseases

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