TO WHAT EXTENT DOES THE FEDERAL JOINT COMMITTEE FOLLOWS THE EVIDENCE BASED RECOMMENDATIONS BY IQWIG

Author(s)

Weber B1, Schmitter S2, Schiffner-Rohe J21Pfizer, Berlin, Germany, 2Pfizer Deutschland GmbH, Berlin, Germany

OBJECTIVES: The Act on the Reform of the Market for Medicinal Products (AMNOG) funds, effective since 01.01.2011, implemented an early benefit assessment of drugs after launch in Germany. The Institute for Quality and Efficiency in Health Care (IQWiG) assesses the benefit of a drug based on a dossier submitted by the pharmaceutical manufacturer. Based on this assessment and the statements by industry, scientific community and patient organizations the Federal Joint Committee (FJC) reviews and decides on the extent of the additional benefit being the basis for price negotiations between the National Association of Statutory Health Insurance Funds and the pharmaceutical manufacturer. The objective is to investigate possible differences between the scientific assessments by IQWiG and the subsequent decisions by FJC. METHODS: We examined all IQWiG assessments and corresponding FJC decisions up to 01.06.2012 regarding possible disagreements. Afterwards we categorized these findings and tried to identify schemes where FJC regularly deviates from IQWiG’s recommendations. We excluded decisions on Orphan drugs because of the special regulations for these drugs. RESULTS: Totally 13 newly launched products were evaluated by IQWiG with subsequent decision on additional benefit by the FJC. An additional benefit is not proven for more than 70% of patient groups. The extent of the additional benefit doesn’t differ between assessment and decision in 8 products. The FJC merges patient populations being separately analyzed by IQWiG in 4 drugs. In case of Eribulin the result of IQWiG assessment is no additional benefit in both subgroups whereas the FJC decides on a slight and smaller benefit in the subgroups. Deviations in number of patients and costs can’t be assessed, because IQWiG doesn’t always provide information on these. CONCLUSIONS: Besides one case there are minor differences between assessments and subsequent decisions. The impact of these differences on the price negotiations is unknown until now.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP157

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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