AN ANALYSIS OF GERMAN AMNOG RE-VIEW ASSESSMENTS AND LEARNINGS FOR MANUFACTURERS

Author(s)

Stoor L, Falk K, Brown A
Abacus International, Manchester, UK

OBJECTIVES: The primary focus of manufacturers’ reimbursement submissions in Germany is on demonstrating the added benefit of a product versus the appropriate comparator(s). Some decisions made by Gemeinsamer Bundesausschuss (G-BA) result in a time-limited approval, after which there should be a review.  This study analyses any completed reviews conducted by the G-BA.  METHODS: G-BA decisions were searched to identify restricted decisions and subsequent reviews. Data were extracted, the reasons for the restrictions and the ways these were addressed in the reviews, were analysed.  RESULTS: CONCLUSIONS: The results indicate that restricted decisions provide manufacturers with the opportunity to collect additional data and improve the final added benefit recommendation. If manufacturers address the G-BA’s criticism of the original submission, more favourable added benefit levels can be achieved during the review. Furthermore, it shows that EMA decisions influence G-BA decision making.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP212

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

Multiple Diseases

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