ACCESS TO MEDICINE, REIMBURSEMENT AND PRICING IN GERMANY- WHAT ARE THE IMPLICATIONS OF AMNOG?

Author(s)

Mueller E, Schmidt E, Schrank L, Neeser K
LASER ANALYTICA, Loerrach, Germany

OBJECTIVES: Since the health care reform in Germany (AMNOG) in 2011, newly approved drugs have to demonstrate their innovation to avoid reference group pricing. The pharmaceutical manufacturer (PM) has to submit a dossier proving additional benefit versus the appropriate comparator recommended by the G-BA (Joint Federal Committee). METHODS: Benefit assessments and G-BA decisions to date were analyzed. Outcome data, indirect comparisons and decisions (until January 2015) were explored with regard to factors potentially impacting the outcome of price negotiations.   RESULTS: CONCLUSIONS: AMNOG mediates price control despite mandatory reimbursement of innovative drugs. Following initial pitfalls in dossier development the withdrawal of 5 drugs in 2012 may indicate that nowadays either the PMs are more familiar with AMNOG or, that drugs with limited potential of proving an additional benefit tend to be not launched in Germany. The majority of price negotiations resulted in reductions of < 20%. It was not possible to identify parameters predicting the magnitude of rebates.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PHP153

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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