> The speakers critically assessed the randomized studies and study criteria required by law, according to which the benefits are to be assessed in accordance with paragraph 137h. One solution that was intensively discussed in this context was that of health economist Prof. Dr. Axel Mühlbacher from Neubrandenburg proposed “adaptive benefit assessment” as a learning process. “In order to meet patients’ justified demands for rapid access to innovative therapies, an urgent need for medical action should be an essential decision-making criterion on the path to approval and reimbursement,” said Mühlbacher.
The challenge lies in quick access to innovations, because patients and their doctors need further developments. When evaluating new types of medical devices, complex balances of benefits and harms lead to time-consuming decision-making processes. In addition, new medical products are increasingly being developed for the treatment of smaller patient populations. Because of the heterogeneity of patient groups, subgroups must be examined more frequently in clinical studies. The question that is currently unclear is whether the required high level of evidence can be achieved for examinations in subgroups within a reasonable period of time. This problem is from...