More than half of new drugs have not been shown to add any benefit, study shows

On 1 January 2011, Germany introduced early benefit assessment (Frühe Nutzenbewertung) of new drugs through the reform of the market for medicinal products act (AMNOG). Its aim is to determine whether a new drug has any added benefit over standard care. The Federal Joint Committee (G-BA), the main decision making body within the German statutory health insurance system, is responsible for the assessment procedure and ultimately decides on the added benefit.

The G-BA specifies the standard care based on criteria laid down in the law. According to these criteria, standard care is an approved and reimbursed intervention that is established in clinical practice and for which a benefit has been proved according to the standards of evidence based medicine (predominantly based on studies with patient relevant outcomes). If appropriate, standard care might also be watchful waiting or best supportive care.

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