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 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.
Close knowledge gaps
One reason for these information deficits could be the accelerated drug approval procedures, which leave less and less time to collect meaningful data for the use of drugs. The hope that the information deficits could be remedied by so-called post-marketing studies has so far not been fulfilled. Such studies are rarely conducted and published - and if they are, they rarely confirm the added benefit of the new drugs. Identifying knowledge gaps after approval and closing them with meaningful data is therefore a very important task for the future.
Furthermore, the authors call for the mandatory requirement to provide meaningful comparisons between new drugs and standard treatment as early as the date of market access. New approaches to drug development that are more strongly orientated towards gaps in treatment options or the goals of healthcare systems could also contribute to better patient care.