Evaluating Global Early Market Access Opportunities For Innovative Therapies: Focus On Japan, Uk And Us

Abstract

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: 148 agents entered the assessment process, 102 dossier completed the whole assessment process. G-BA evaluations resulted in 26 minor, 21 considerable, and 55 not quantifiable/no additional therapeutic benefit of assessed vs. comparator drug. In 29 cases the G-BA did not follow IQWiG's conclusions of the extent of additional benefit. The choice of appropriate comparator was controversial between G-BA and PM in 10 cases, followed by questions about evidence of benefit. 5 drugs, which failed to prove an additional benefit, were withdrawn from the German market. In a sub-analysis 18 drugs were examined, where the reimbursed price has been negotiated between the National Association of Statutory Health Insurance Funds (GKV-SV) and PM. The mean rebate was 17% with a range from 0 to 52%. Negotiated rebates were not correlated with any of the clinical and economic parameters (e.g. number of patients benefitting, proposed price) analyzed. 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.