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