![]() ![]() The result of the benefit assessment is published on the internet, and pharmaceutical companies, federations, and experts are given the opportunity to submit written and verbal statements on the result.Īfter another three months, the G-BA passes a resolution based on the benefit assessment and the hearings. The G-BA can delegate the benefit assessment to the Institute for Quality and Efficiency in Health Care (IQWiG) or third parties. The dossier must prove an additional benefit of the medicinal product over the appropriate comparator specified by the G-BA. For this purpose, the company submits a dossier to the G-BA based on the authorization documents and all studies carried out on this medicinal product. Within three months of market authorization of a new medicinal product, the G-BA assesses recognition of any additional benefit claimed over the appropriate comparator. The responsibilities of the G-BA following AMNOG For the first time, pharmaceutical companies are obliged to submit a dossier on product benefit when a new product is launched on the German market or authorized for new indications. This law went into effect on 1 January 2011. Since 2011, their findings form the basis of decisions on the prices statutory health insurance providers pay for new medicinal products with new active ingredients. It also assigns a key responsibility to the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG): that of conducting benefit assessments of newly authorized medicinal products in accordance with SGB V, section 35a. It completely revises pricing regulations for newly authorized medicinal products and their reimbursement by statutory health insurance providers. The German parliament passed the Act on the Reform of the Market for Medicinal Products (AMNOG) on 11 November 2010. The benefit assessment of medicinal products in accordance with the German Social Code, Book Five (SGB V), section 35a This page compiles information on the benefit assessment of medicinal products in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG). ![]()
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