>> The speakers agreed that the safety of medical devices is in the interest of everyone involved and that a benefit assessment offers opportunities. For a further benefit assessment of interventions using high-risk medical devices, uniform evaluation criteria and a precise definition of value and benefit are necessary. The benefit assessment not only includes measuring and recording clinically relevant study data, but also their defined evaluation. “When assessing the clinical effects of a technology, decision-making bodies must rely on uniform value judgments. For this reason, individual decision-makers should formulate their value judgments based on patient preferences,” explained health economist Prof. Dr. Axel Mühlbacher from Neubrandenburg.
Similar to the outpatient sector, the Federal Joint Committee (G-BA) will decide in the future whether an examination and treatment method with medical devices of a high risk class and invasive nature will achieve special reimbursement in hospitals or whether it will be used at all. Among other things, the speakers criticized the GKV-VSG draft law for not clarifying which innovations should be examined for their benefits in the future. The definition in the draft law, according to which manufacturers and hospitals only have to submit studies if the new method is based on a new “theoretical scientific concept” and the application of which “has a particularly invasive character,” is still pending. In addition, according to the experts, there is still a lack of statements on the systematics, target criteria and further use of a benefit assessment. The planned timelines could also be too short, and there are fears that medical product innovations will reach the market later than before.
The discussion made it clear that the benefits of medical devices are in the interests of everyone involved. Although each interest group has its own values, a similar approach is evident in the individual positions: For the patient representative, Dr. Siiri Doka from the Federal Working Group on Self-Help, the value of a medical device in that it is safe... <<