It takes an average of 1.7 months for a newly approved drug to be available to German patients; for orphan drugs, it is only 1.3 months on average. In other countries it takes many times longer, up to a year and a half in France, for example.
The reason for this, explained Han Steutel, the President of the Association of Research-Based Pharmaceutical Companies (vfa) at a symposium of the Federal Joint Committee on the occasion of a ten-year review of the AMNOG, is that benefit assessments and price negotiations based on them do not start until after the market launch . In other countries, prices have to be negotiated first, which delays the market launch.
If the negotiated price is not lucrative enough, the manufacturer can still decide not to serve the market in the first place. Steutel explains the supply advantage for Germany as follows: “It is much easier for a company to make a decision not to introduce a new product in the first place than to take it off the market later.”
Sales hopes disappointed in reality
The decision of the legislature a good ten years ago to forego a fourth hurdle gave patients the chance of access to innovations – but not more. Because there is no reliable and unambiguous knowledge about the extent to which the outcome of benefit assessments influences the behavior of doctors who prescribe them.
One example of this is the first product evaluated in 2011, ticagrelor. Because the sales hopes that the manufacturer had made based on the assessment of “considerable additional benefit” were rather disappointed in the reality of supply.
According to Professor Bernhard Wörmann from the German Society for Medical Hematology and Oncology, an essential aspect is that an innovation meets a high level of “unmet medical need”, which also makes the patient suffering very high.
In addition, diseases that, when treated, the effect of innovations on hard endpoints such as overall survival can be observed quickly and easily – a fact that puts new therapeutic approaches in oncology at an advantage over diabetology, for example, says Wörmann.
It’s good that professional associations are on board
Everyone involved in the benefit assessment process agrees that better involvement of specialist societies, including the doctors’ drug commission – most recently made mandatory by law – has positive effects. Possibly also on the doctor’s prescription behavior.
However, this is influenced more by guidelines than by benefit assessment decisions – but the new quality of data and study transparency resulting from the benefit assessment is meanwhile also influencing the guidelines of the specialist societies.
In addition, after several years of preparatory work with the doctor information system, doctors have access to the results of benefit assessments as a digital information tool in their practice software. According to Sibylle Steiner from KBV, the guiding principle for action was to avoid a flood of information and to make relevant information available at a glance. This is also important for general practitioners, 90 percent of whom use AMNOG drugs.
However, this information also has its limits, according to Professor Dirk Müller-Wieland from the German Diabetes Society: Doctors not only consider and compare preparations, but also have more complex therapeutic strategies in mind. This applies in particular to chronic diseases accompanied by comorbidities.
In this context, from a medical point of view, the question arises of what additional use, for example, an add-on therapy with an innovation is. According to Müller-Wieland and Wörmann, this is not recorded in an isolated benefit assessment.