AMNOG DOSSIERS AS A CHALLENGE FOR PHARMACEUTICAL COMPANIES- IS THERE A CORRELATION BETWEEN VOLUMES AND ADDED MEDICAL BENEFIT?
Author(s)
Kulp W, Reinartz MT
Xcenda GmbH, Hannover, Germany
OBJECTIVES: Since the enactment of AMNOG in Germany in 2011, 238 dossiers have been submitted to G-BA. A dossier is mandatory for pharmaceutical companies in order to be able to realize a price higher than the price of the appropriate comparator defined by G-BA in the price negotiation, given an added medical benefit is granted. However, the efforts and resources to assemble an AMNOG dossier are extensive and, oftentimes, underestimated by companies. One major challenge are the extensive mandatory data requirements that go beyond respective requirements posed by EMA or FDA. METHODS: Volume (number of pages) of Modules 1-4 was used as a proxy for efforts and resources to write an AMNOG dossier. Module 4 contains clinical data on which added medical benefit is assessed. Hence, volume of module 4 was compared to the respective added medical benefit to conclude on possible correlation. RESULTS: CONCLUSIONS: For non-orphan drugs, uncertainty in regard with the presumed added medical value seems to translate into greater volume of the dossiers. The inverse effect in orphan drugs might be attributable to the fact that more comprehensive clinical data might facilitate emphasizing the clinical value of drugs thus leading to a higher rating.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP257
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases