On January 1, 2011, the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) was introduced with the objective of assessing the added value of new drugs, in particular looking at potential cost containment and savings in the pharmaceutical sector, enabling access to medicines for patients and a reliable framework for the pharmaceutical industry. With the launch of a new product, the manufacturer has to submit a dossier to the Joint Federal Committee, which is the basis for the assessment of the early benefit evaluation. The final assessment of the Joint Federal Committee forms the basis for the subsequent reimbursement price negotiations, based on the price of standard therapy, with the Federal association of statutory health insurances (GKVSpitzenverband). The “AMNOG” dossier presents, besides the demonstration of the benefit, the therapy costs which are relevant for the GKV focusing mainly on the drug costs. At the same time, however, the benefit has to be presented in accordance with § 35a SGB V according to the "international standards of evidence-based medicine and health economics". The present thesis addresses the question of whether the AMNOG, after three years of first completed procedures, could meet its objective to evaluate the benefit of a drug in accordance with the standards of evidence-based medicine and international health economics and lay the foundation for value-based price negotiation and thus increases welfare. An evaluation of the completed early benefit assessments over three years can demonstrate that the health economic evaluation currently plays no role within the early benefit assessment. Simply focusing on the costs of drugs and the costs of the application as only these costs are relevant for the SHI system, cost offsets are excluded. The assessment has a period of one year, which also speaks against international standards of health economics. Focusing on the cost reduction of SHI within the framework of the AMNOG leads in a welfare economic analysis to an increase in consumer surplus, but ignores dynamic development effects of innovations. The use of health economic evaluation, for example in health technology assessments, shows how a particular value for money can be established, but not the determination of the price. The price is formed as a balance between the society’s willingness to pay for innovation and the manufacturer's investment in innovation. Health economics provides essential recommendations for this. One possibility would be to establish a regulatory framework that enables decentralized contracts. A competition in e.g. selective healthcare contracts taking into account the interests of all market participants, based on information from jointly defined health economic evaluation, can lead to an increase in the quality of care.
|School:||Universitaet Bayreuth (Germany)|
|Source:||DAI-C 81/1(E), Dissertation Abstracts International|
|Subjects:||Economics, Health care management|
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