PARTICIPATION OF EXTERNAL MEDICAL SOCIETIES IN THE BENEFIT ASSESSMENT OF PHARMACEUTICALS IN GERMANY

Author(s)

Bleß H, de Millas C, Kern B
IGES Institut GmbH, Berlin, Germany

OBJECTIVES: Every new molecule entity undergoes a benefit assessment by the Federal Joint Committee (G-BA) in Germany. After an assessment of the dossier by the Institute for Quality and Efficiency in Health Care (IQWiG) or the G-BA, external experts can comment during an appraisal process. This research aims to explore how specific external experts (medical societies (MS) and the Drug Commission of the German Medical Association (AkdÄ)) differ from the opinion of the assessment and whether the G-BA agrees or disagrees with them regarding additional benefit, appropriate comparator (AC) and endpoints. METHODS: All 136 benefit assessments regularly completed between January 2011 and August 2015 were systematically reviewed. It was determined if MS and AkdÄ recommended a higher, lower or equal additional benefit compared to the assessment. Regarding the AC, experts’ agreement or disagreement with the choice in the assessment was determined. Endpoints were evaluated (agree/ disagree) when at least one expert disagreed with the assessment. RESULTS: AkdÄ or MS disagreed with 74/136 of all assessments concerning the additional benefit. MS recommended a higher additional benefit more often (118/140) than the AkdÄ (8/45). A lower additional benefit was recommended in 2/140 (MS) respectively 9/45 (AkdÄ) of all statements. When MS/ AkdÄ recommended a higher benefit, the G-BA accorded with 54/118 respectively 6/8 of all statements. Regarding the other subjects, the concurrence rate was 14/79 respectively 4/21 in case of AC and 33/135 respectively 16/35 in case of controversial endpoints. CONCLUSIONS: The high number of divergent opinions between assessment, medical experts and final appraisal demonstrate the need for discourse. The authors recommend to improve the process: involvement of medical experts in the choice of the AC; earlier access for medical experts to dossiers; greater transparency towards considered external opinions by the G-BA; including medical experts as voting members of the appraisal board.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

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

Code

PHP216

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Multiple Diseases

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