Early benefit assessments: 220th dossier assessment completed by the turn of the year
In the course of 2017, the German Institute for Quality and Efficiency in Health Care (IQWiG) completed its 200th dossier assessment: The results of the 216th to 220th early benefit assessments were published at the turn of the year. A comparison of the therapeutic indications shows: Oncology is way ahead when it comes to both the number of investigated drugs and the proportion of drugs with at least a hint of an added benefit. The proportion of drugs with confirmed added benefit is particularly low for psychiatric and neurological diseases.
In roughly 30 percent of the dossier assessments, the Federal Joint Committee (G-BA) comes up with a different conclusion than IQWiG. The number of cases where the G-BA conclusion was better than the IQWiG findings roughly corresponded to the number of cases where the G-BA conclusion was worse – mainly due to new findings derived from the commenting procedures on the IQWiG assessments.
Over the years, IQWiG and the G-BA have had to reassess the same drug increasingly often, either after a limitation or with regard to a new therapeutic indication. Moreover, several drugs for the same therapeutic indication undergo early benefit assessment with increasing frequency. Comparisons among these drugs would be useful to facilitate better practical application of the findings yielded by the early benefit assessment.
Oncology drugs present the largest proportion of drugs with added benefit
An analysis of all dossier assessments completed by the end of 2017 shows: Oncology is way ahead, while other diseases that are widespread in the population and entail enormous hardships are scarcely addressed in a dossier. The new drugs against cancer also have the highest rate of success: An added benefit was not confirmed or the benefit was even lower than that of the comparator therapy in only about 40 percent of these drugs. This balance was even better in case of new drugs against hepatitis C. Conversely, the data showed an added benefit for only 20 percent of the antidiabetics and for as few as 10 percent of the psychiatric and neurologic drugs.
Advances through immunotherapies
"In oncology, we have experienced several new therapeutic approaches in recent years, e.g. the immunotherapies", says Thomas Kaiser, Head of IQWiG's Drug Assessment Department. "We could observe clinically significant survival advantages particularly for some advanced cancers with hitherto poor prognosis. For individual therapeutic indications however, the amount of data provided by the approval studies is very small. The new drugs also have noticeable disadvantages, e.g. severe side effects on the immune system. In many cases, however, the increase in survival time or the improvement of quality of life outbalances these drawbacks. Compared with some chemotherapies, the balance turns out to be positive also with regard to the side effects. Unfortunately, equivalent advances are lacking for other diseases involving similar need for action, such as Alzheimer dementia."
IQWiG and G-BA agree in 70 percent of all cases
In its decisions, the G-BA agrees with the assessments of IQWiG on the extent of added benefit in roughly 70 percent of all cases. The diverging assessments can virtually be divided in a ratio of 50:50 into cases in which the G-BA assumed greater added benefit and those in which IQWiG found a greater added benefit. The most important reason for these deviations was the provision of new data from the commenting procedures on the IQWiG assessments considered in the G-BA decisions.
No references to other dossier assessments so far
The early benefit assessment was introduced in 2011, along with the Act on the Reform of the Market for Medicinal Products (AMNOG). Now, after more than six years, the assessment procedure is working out well. However, the weaknesses are becoming increasingly obvious for the IQWiG researchers. The more often they subsequently assess several drugs from the same therapeutic indication, the more confusing the results become for the users. The procedure does not allow comparisons with already completed assessments of other drugs. However, comparative assessments could support physicians and patients in their decision-making.
Dr. Anna-Sabine Ernst