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10 cases, followed by questions about evidence of benefit. 5 drugs, which failed to prove an additional benefit, were withdrawn from the German market.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.
OBJECTIVES:In Argentina, the public health system is deeply decentralized and organized mainly at the provincial level. In this context, differences regarding income distribution and access to health services require the creation of regulatory devices and State intervention. One of the answers provided by the Buenos Aires Health Ministry was the creation of Provincial Public Health Insurance. This program included an innovative mechanism of human resources payment for the public sector-a capitated system with the possibility to generate a plus over the fixed salary-and aimed to reach the coverage of 2.4 million of citizens. The object of this research is to analyze the performance of the strategy in terms of focalization and development of preventive tasks associated to a higher quality at the primary healthcare level. METHODS: A database of 1.7 million of consultations in 59 municipalities during the period 2004 to 2006 was analyzed, considering the evolution of preventive and curative consultations. Logistic regression models were implemented to determine the variables conditioning those tendencies. RESULTS: The program was appropriately focalized in poor municipalities. Preventive consultations increased 107% during the three-year period, and curative consultations decreased by 56%. Preventive consultations were significantly associated with young and female patients, as well as younger physicians. Also, poor and populated municipalities showed high associations with preventive consultations. Differences between municipalities were relevant, showing significant associations on both signs. CONCLUSIONS: The insurance's hiring and payment mechanisms, result to be innovative and successful in the context of public health subsector, conditioning the professionals to increase their efforts towards higher quality preventive care. The strategy might be seen as one of the instruments with the potential to enhance care quality and performance. Nevertheless, municipalities show particular characteristics regarding their management and administrative structures that affect the success of the program.
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