Early benefit assessment reveals weaknesses in new drug development, says Germany's IQWiG

The German Act on the Reform of the Market for Medicinal Products (AMNOG) was introduced in 2011 to regulate the early benefit assessment of new drugs. More than half of the drugs that have entered the market in Germany since then have emerged from these assessments without any proven added benefit.

In a publication in the British Medical Journal using the first 216 assessments, researchers from the Institute for Quality and Efficiency in Health Care (IQWiG) examine the reasons for this sobering result and develop suggestions for improvements in drug development.

Beate Wieseler, head of the IQWiG’s Drug Assessment Department and first author of the article, notes: "There are three reasons for the conclusion 'added benefit not proven'. Often simply no studies are available comparing the new drug with the standard treatment for the disease. In other cases studies are available, but the control treatment is unsuitable, for example, because it is not approved for the patients investigated. In this situation, there is no information that could support the decision by patients and physicians for one of the available treatment alternatives. In a smaller number of cases, suitable studies comparing new drugs and standard treatment are available, but do not show any clear advantages or disadvantages.”