ROLE OF INDIRECT COMPARISONS IN THE AMNOG EVALUATION PROCEDURE

Author(s)

Bustamante MM1, Gambari J2
1CBPartners, New York, NY, USA, 2CBPartners, London, UK

OBJECTIVES: The AMNOG assessment procedure requires that manufacturers submit indirect comparisons for the assessment of molecules in the absence of direct comparisons versus the G-BA appropriate comparator. The purpose of this study was to understand the role that indirect comparisons have in IQWiG’s assessment of added benefit and consequently also on the G-BA decision outcome.  METHODS: The IQWiG assessments and G-BA evaluations through the AMNOG process from initial implementation to the end of 2014 were analysed based on publications from the G-BA website. 104 molecules that had gone through the AMNOG procedure were identified and further categorised in order to determine whether they had submitted direct, indirect, or both types of comparisons. The G-BA publications by means of the classification score were used to source and quantify the outcome of the decision. RESULTS:

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PHP141

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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